Peri-ImplantitisNCT05699343
Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane
A study testing InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane) and InterOss Collagen (Bone xenograft) in people with Peri-Implantitis and Surgery, run by Andrea Ravida at 1 site in United States.
Trial summary
The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air powder abrasive (APA) decontamination of implant surfaces, in combination with the placement of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Surgery
- What is being tested?
- InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane) and InterOss Collagen (Bone xenograft)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: To be enrolled, the participant must meet the following inclusion criteria:
- age 18 years or older
- be patients of record at the University of Pittsburgh Periodontics Department
- Systemically healthy patients
- Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at six sites per tooth)
- Study individuals will be included if they met the following criteria: (a) one or more peri-implant sites with PPD ≥6 mm combined with BOP/suppuration, and (b) peri-implant marginal bone loss, defined as a crater like defect ≥3 mm as assessed from intra- oral radiographs, (c) Infrabony circumferential defect of more than 270° determined by CBCT, (d) crown not possible to retrieve before surgery
Exclusion Criteria:study individuals will be excluded if any of the folllowing apply:
- Unlikely to be able to comply with study procedures and unable to return to SDM for multiple appointments over the course of about a year.
- Uncontrolled pathologic processes in the oral cavity (cancer and active periodontal disease)
- History of allergic reactions to dental local anesthetics
- History of head and neck chemotherapy or radiation within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, such as HIV infection, Paget's disease, osteoporosis, etc.
- Reported diagnosis of diabetes mellitus
- Patients taking corticosteroids, IV bisphosphonates, or any immunosuppressant medication that could influence post-operative healing and/or osseointegration
- Smokes more than 10 cigarettes/day (self-reported)
- History or current medications with known side effects of gingival growth (including any of the following: phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, diltazem, amlodipine, felodipine, verapamil, cyclosporine).
- Present alcohol and/or drug abuser (self-reported)
- Pregnant, unsure pregnancy status, or lactating females (self-reported), or planning to become pregnant within 1 year of study enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane. A Randomized Clinical Trial
The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air powder abrasive (APA) decontamination of implant surfaces, in combination with the placement of a bone graft, differs in treatment outcomes compared to placing the same bone graft material with a resorbable collagen membrane placed over the bone graft.
Read the detailed description
The purpose of the study is to compare treatment outcomes of peri-implantitis defects when using a defect fill substitute (InterOss Collagen), against the treatment outcome when placing the same defect fill substitute with a resorbable collagen membrane (InterCollagen Guide). There is no current literature to suggest that placing a collagen membrane over a bone grafting material in an infrabony defect of more than 270 degrees is more effective than placing the bone graft material alone. The present study will help in understanding if such defects require an additional placement of a collagen membrane which could increase the cost of the procedure for the practitioner and the patient.
The study will be conducted at the University of Pittsburgh School of Dental Medicine Graduate Periodontics Department. A detailed description of research activities during each patient visit is provided below.
Screening Visit (V0):
Prior to starting any of the procedures, the subject will complete the informed consent interview. Patients will be screened to assess for inclusion in the study. Vitals (blood pressure and heart rate) will be measured and medical history will be discussed. Limited field of view (FOV) cone beam computed tomography (CBCT) scan will be taken and examined prior to the study to determine the presence of a 270 degree circumferential boney defect for inclusion in the study. Probing pocket depths (PPD), plaque sites, mobility and bleeding on probing (BOP) are clinical measurements that will be completed. The visit will take approximately 1.5 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Pre-surgical phase (V1):
If the patient is eligible and willing to participate in the study following the screening visit, they will return for V1. Their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events from the previous visit will be assessed. A periapical (PA) radiograph will be taken to confirm a crater like defect >=3mm. The prosthetic superstructures (implant crowns) will be removed followed by placement of cover screws. PPD will be measured twice (with and without the implant crown). Bleeding on Probing (BOP), suppuration, mobility, and plaque sites will be recorded. Clinical photographs will be taken of the teeth and inside of the mouth. Generalized supragingival debridement will be performed. Patients will be informed that newly fabricated crowns might be needed after the treatment as part of the study. During this visit, patients will be also re-instructed and emphasized on maintaining proper at-home oral hygiene measures with a soft-bristled toothbrush for minimizing trauma to marginal soft tissues. The visit will take approximately 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Surgical treatment procedures (V2) After 4 to 6 weeks, the patient will undergo regenerative surgical procedure. Their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. The Study individuals will receive a local anesthetic as needed by the surgeon. Intra-sulcular, and if necessary, vertical releasing incisions will be made. Soft tissue flaps will be elevated at buccal and lingual aspects providing adequate access. Granulation tissue and mineralized deposits at implants will be removed using titanium curettes. The implant surfaces will be decontaminated with airflow. Once the surgical site was debrided, clinical intra-surgical measurements will be made. The measurement of peri-implant defect depth will be made clinically intra-surgically. Defects will be measured by calibrated examiners using a periodontal probe. The depth will be measured to the deepest point of the defect. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) - (Measurement at re-entry procedure). The defect resolution (DR) on the other hand will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth. The horizontal defect, width of keratinized tissue, and soft tissue thickness will also be measured at this visit.
Thereafter, study individuals will be randomized to control or test groups using the SPSS randomization method (SPSS PASW 23.0 statistical software package, SPSS Inc., Armonk, NY, USA). Depending on the randomization, one of the following therapies was used: (a) (control group); bone grafting alone (InterOss Collagen) will be placed. (b) (test group); the intraosseous component will be filled with bone grafting (InterOss Collagen) and covered with a resorbable collagen membrane (InterCollagen Guide). InterOss Collagen is an FDA cleared for use in guided bone regenerative procedures. InterOss Collagen is a bovine derived anorganic hydroxyapatite collagen composite composed of 90% bovine granules and 10% collagen fibers molded in a block form. InterCollagen Guide is an FDA cleared porcine derived resorbable collagen membrane intended for periodontal and dental surgeries. In both groups, if needed, a periosteal releasing incision will be made to allow complete coverage of the wound area. In both study groups, surgical soft tissue flaps will be sutured with interrupted sutures without tissue tension using 4/0 or 5/0 PGA providing full wound closure. Clinical photographs will be taken again, and surgical video may be recorded when possible. All study individuals will receive postoperative antibiotics and prescribed post-operative pain relievers, as well as care instructions.
The postoperative medications may include:
Amoxicillin 500 mg 3 x 7 days
- Clindamycin 300 mg 4 x 7 days Ibuprofen 600 mg PRN Chlorhexidine 0.12% rinse 2 x 2 weeks Tylenol 3 (300mg-30mg)* Medrol Dose Pack (as needed) Instructions not to wear any removable prosthesis during the healing phase
- Administer if drug allergy to Amoxicillin *Administer as alternative to Ibuprofen
The visit will take approximately 2.5-3 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
4 weeks post op (V3) After 4 weeks (± 2 days), the patient will return for follow-up. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Sutures will be removed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Re-entry procedure and replacement of superstructures (healing abutment) (V4) After 4 months of uninterrupted healing, patients will return for the re-entry procedure. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. A standardized PA radiograph will be taken at this visit. Intrasulcular incision will be performed on the adjacent teeth and midcrestal incision at the implant location. Full thickness flap will be elevated, and the same defect measurements taken during the surgical procedures will be performed to obtain clinical changes in peri-implant bone levels. Where the defect fill will be measured as the difference in millimeters between the initial measurements taken at baseline and the depth of defect present at follow up. During the re-entry procedure, if the bone defect around the implant is not completely filled after V2, (it happens that we succeed to feel 60-70% of the defect, but not the whole defect), additional bone grafting material will be added after taking intra-surgical measurements. Please note the same bone graft material will be used, and will not involve additional clinical procedures, since the flap is open for the re-entry procedures. The outcome of "complete bone fill?" Yes/No will be recorded on the Visit form. Then, implant cover screws will be replaced by appropriate healing abutments, followed by single interrupted sutures for re-adaptation of the flap. Clinical photographs will be taken again, and surgical video may be recorded. Finally, a periodontal maintenance will be performed. The visit will take approximately 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident. During this period, if needed new crowns will be designed, fabricated, and delivered to all patients and for all treated implants.
Post op after stage 2 (V5) Approximately 2 weeks after V4, subjects will return for V5. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Sutures will be removed. If a new crown is needed, digital impression will be taken with the Trios hand-held scanner, and patient will be referred to receive a new crown. If no new crown is needed, the old crown will be replaced at the next visit. Clinical photographs will be taken again. The visit will take approximately 1-2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Crown placement/replacement (V6) Approximately 1 month after V5, the subjects will return for the Implant Crown replacement. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. The old crown or the new crown will be placed in the treated area. A radiograph may be taken to assist in placement. The visit will take approximately 1- 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
8 months visit (V7) For V7, subjects will return at approximately 8-months post-op. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Probing pocket depth (PPD), recession, BOP, plaque, suppuration and mobility measurement will be recorded. Radiographic measurements (bone fill) will be obtained as performed at the pre-surgical visit (time point 1). Dental prophylaxis and periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
12 months visit (V8) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the pre-surgical visit (time point 1) using a standardized PA radiograph. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 2:
15, 18, 21, 24 months visit (V9, V10, V11, V12) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V12, timepoint 24 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 3:
27, 30, 33, 36 months visit (V13, V14, V15, V16) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V16, timepoint 36 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 4:
39, 42, 45, 48 months visit (V17, V18, V19, V20) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V20, timepoint 48 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 5:
51, 54, 57, 60 months visit (V21, V22, V23, V24) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V24, timepoint 60 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Clinical measurements:
- The following baseline procedures will be performed; (a) Intra-oral photographs and intra-oral radiographs of the implant sites; (b) clinical recording of full mouth plaque scores (FMPS) (presence of dental plaque along the peri-implant mucosal margin (gingival margin at teeth) was expressed as a percentage of examined sites within each subject including four sites per tooth and implant, (c) clinical recording of local plaque score (LPS) (presence of dental plaque along the mucosal margin at four sites of each treated implant and expressed as a percentage of implant sites within each subject), (d) clinical recording of probing pocket depths (PPD) (at all teeth, and the specific implant in the study (four sites; implant/tooth) to the nearest millimeter with a North Carolina probe (e) clinical recording of full mouth bleeding scores calculated as the percentage of assessed surfaces with BOP, (f) BOP will also be assessed with the North Carolina probe at four sites per implant. The bleeding will be graded; 0 = no bleeding, 1 = dot of bleeding, 2 = line of bleeding and 3 = drop of bleeding (Mombelli, van Oosten, Schurch, \& Lang, 1987), (g) clinical recording of recession at the peri-implant mucosal margin (buccal/lingual-palatal) relative to a fixed reference point on implants and (h), clinical recording of presence/absence of suppuration (SUP) at the implant (4 sites/implant).
- Peri-implant defect depth will be made clinically intra-surgically. Defects will be measured by calibrated examiners using a periodontal probe. The depth will be measured to the deepest point of the defect. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) - (Measurement at re-entry procedure). The defect resolution (DR) will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth.
- MBL will be calculated based on standardized radiographs using registered bite-block with a Rinn (Dentsply Rinn, Elgin, IL, USA) film holder and expressed as the distance from the implant shoulder to the most coronal bone-to-implant contact (BIC) on the mesial and distal side of the implant. The mean values will be calculated for each implant. In the case that the bone levels around the study implants are hidden or difficult to read, new radiographs will be taken. Peri-implant marginal bone levels will be measured using the ImageJ software* (ImageJ, U. S. National Institutes of Health, Bethesda, Maryland, USA) (Schneider, Rasband, \& Eliceiri, 2012). The software will be calibrated for every single image using the known implant length or the length of the implant collar. Measurements of the mesial and distal bone crest level adjacent to each implant will be rounded to the nearest 0.1 mm. Implants with bone up to the coronal margin of the implant collar will be given a value of zero. Mesial and distal measurements of each implant are averaged, and a mean calculated at patient level and then at group level. Implant failure: It will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0-mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
- Conditions
- Peri-Implantitis, Surgery
- Being tested
- InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane), InterOss Collagen (Bone xenograft)
- Keywords
- peri-implantitis, bone augmentation, collagen membrane, surgical treatment, dental implant
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane)Procedure or surgery
Group will receive InterOss Collagen and InterOss Collagen Guide during surgical intervention visit.
InterOss Collagen (Bone xenograft)Procedure or surgery
Group will only receive InterOss Collagen during surgical intervention visit.
| Study group | Role | What they receive |
|---|---|---|
| Bone grafting with collagen membrane | Experimental | This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with a collagen membrane (InterCollagen Guide) placed over the bone graft. Receives: Procedure: InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane) |
| Bone grafting without collagen membrane | Active comparator | This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with no collagen membrane placed over the graft. Receives: Procedure: InterOss Collagen (Bone xenograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Treatment of Peri-Implantitis
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy.
These criteria will be assessed at 12 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Measured: 1 year
Successful Treatment of Peri-Implantitis
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy.
These criteria will be assessed at 24 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Measured: 2 years
Successful Treatment of Peri-Implantitis
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy.
These criteria will be assessed at 36 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Measured: 3 years
Successful Treatment of Peri-Implantitis
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy.
These criteria will be assessed at 48 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Measured: 4 years
Successful Treatment of Peri-Implantitis
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy.
These criteria will be assessed at 60 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Measured: 5 years
Secondary outcomes (10)
Radiographic Marginal Bone Loss (MBL)
Marginal bone loss (MBL) will be calculated based on standardized radiographs using registered bite-block with a film holder and expressed as the distance from the implant shoulder to the most coronal bone-to-implant contact (BIC) on the mesial and distal side of the implant. The mean values will be calculated for each implant. Peri-implant marginal bone levels will be measured using the ImageJ software. The software will be calibrated for every single image using the known implant length or the length of the implant collar. Measurements of the mesial and distal bone crest level adjacent to each implant will be rounded to the nearest 0.1 mm. Implants with bone up to the coronal margin of the implant collar will be given a value of zero. Mesial and distal measurements of each implant are averaged, and a mean calculated at patient level.
Measured: 8 months
Radiographic Marginal Bone Loss (MBL)
MBL will be calculated based on standardized radiographs using registered bite-block with a film holder and expressed as the distance from the implant shoulder to the most coronal bone-to-implant contact (BIC) on the mesial and distal side of the implant. The mean values will be calculated for each implant. Peri-implant marginal bone levels will be measured using the ImageJ software. The software will be calibrated for every single image using the known implant length or the length of the implant collar. Measurements of the mesial and distal bone crest level adjacent to each implant will be rounded to the nearest 0.1 mm. Implants with bone up to the coronal margin of the implant collar will be given a value of zero. Mesial and distal measurements of each implant are averaged, and a mean calculated at patient level.
Measured: 12 months
Peri-Implant Bleeding on Probing
Clinical measurements will be taken at 8 months following the surgical procedure and compared to baseline measurements. Following probing measurements, bleeding on probing will be recorded at 6 sites around the implant (mesial facial, distal facial, facial, mesial lingual, distal lingual and lingual). Bleeding will be recorded as present if bleeding occurs within 30 seconds of probing a site and will be recorded as absent if no bleeding occurs.
Measured: 8 months
Peri-Implant Bleeding on Probing
Clinical measurements will be taken at 12 months following the surgical procedure and compared to baseline measurements. Following probing measurements, bleeding on probing will be recorded at 6 sites around the implant (mesial facial, distal facial, facial, mesial lingual, distal lingual and lingual). Bleeding will be recorded as present if bleeding occurs within 30 seconds of probing a site and will be recorded as absent if no bleeding occurs.
Measured: 12 months
Peri-Implant Probing Depth
Clinical measurements will be taken at 8 months following the surgical procedure and compared to baseline measurements. Probing depths will be recorded on 6 sites around the implant (mesial facial, distal facial, facial, mesial lingual, distal lingual and lingual). All clinical measurements will be made in millimeters and measured using a standard periodontal probe and by one examiner.
Measured: 8 months
Peri-Implant Probing Depth
Clinical measurements will be taken at 12 months following the surgical procedure and compared to baseline measurements. Probing depths will be recorded on 6 sites around the implant (mesial facial, distal facial, facial, mesial lingual, distal lingual and lingual). All clinical measurements will be made in millimeters and measured using a standard periodontal probe and by one examiner.
Measured: 12 months
Clinical Peri-Implant Bone Defect Fill
Peri-implant bone defect depth will be measured clinically during initial surgical procedure and at uncovery to determine clinical bone defect fill (DF). The bone defect will be measured using a prefabricated acrylic stent stabilized on adjacent teeth. The depth will be measured from the marked area of the stent to the deepest point of the defect using a standard periodontal probe and recorded in mm. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) - (Measurement at re-entry procedure).
Measured: 4 months
Clinical Peri-Implant Bone Defect Resolution
Peri-implant bone defect depth will be measured clinically during initial surgical procedure and at uncovery to determine bone defect resolution. The bone defect will be measured using a prefabricated acrylic stent stabilized on adjacent teeth. The depth will be measured from the marked area of the stent to the deepest point of the defect using a standard periodontal probe and recorded in mm. The defect resolution (DR) will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth.
Measured: 4 months
Patient Reported Pain Outcomes
Patients will be provided with numerical pain assessment forms following each surgical intervention and these forms will be collected at the post operative visits. Patients will be instructed to record post operative pain using a numerical Pain Scale with 0 being no pain and 10 being the worst pain. Patients will begin recording pain scales starting the day of surgery and continue daily for 7 days. Patient will return the completed form at the 2 week post operative visit following the uncovery surgical procedure. This data will be used to assess if there are any differences in patient reported pain outcomes between both groups.
Measured: 2 weeks
Patient Reported Pain Outcomes
Patients will be provided with numerical pain assessment forms following each surgical intervention and these forms will be collected at the post operative visits. Patients will be instructed to record post operative pain using a numerical Pain Scale with 0 being no pain and 10 being the worst pain. Patients will begin recording pain scales starting the day of surgery and continue daily for 7 days. Patient will return the completed form at the 4 week post operative visit following the first surgical procedure. This data will be used to assess if there are any differences in patient reported pain outcomes between both groups.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 Jan 2023
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study will be a parallel, randomized single center clinical trial where participants will be randomized in to 2 groups: treatment with or without resorbable collagen membrane.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Ravida
- Sponsor type
- University, hospital or other
- Collaborators
- SigmaGraft Inc.
- Responsible party
- Sponsor-investigator, Andrea Ravida, University of Pittsburgh
- Investigators
- Andrea Ravida, DDS MS PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699343
- Sponsor's protocol ID
- STUDY22080031
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Research study data will be stored separately from medical records. Consent forms and copies of letters/correspondence will be stored separately from the research data. Data will be coded with a participant code number which will be assigned consecutively as subjects are enrolled. There will be an excel spreadsheet containing the linkage code to the identifiable patient name or Axium number. This spreadsheet will be password protected and only accessible to the research team and will be saved in a separate location then the medical records (such as OneDrive). De-identified research data will be shared with the sponsor and may be shared with other researchers studying similar conditions. In any publication of this data, confidentiality of individual subjects will be protected. De-identified data may be shared with other researchers or federal repositories in the future under an approved sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05699343
- Acronym / sponsor ID
- STUDY22080031
- Conditions
- Peri-Implantitis, Surgery
- Keywords
- peri-implantitis, bone augmentation, collagen membrane, surgical treatment, dental implant
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Andrea RavidaUniversity, hospital or other
- Collaborators
- SigmaGraft Inc.
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air powder abrasive (APA) decontamination of implant surfaces, in combination with the placement of a bone graft, differs in treatment outcomes compared to placing the same bone graft material with a resorbable collagen membrane placed over the bone graft.
Detailed description
The purpose of the study is to compare treatment outcomes of peri-implantitis defects when using a defect fill substitute (InterOss Collagen), against the treatment outcome when placing the same defect fill substitute with a resorbable collagen membrane (InterCollagen Guide). There is no current literature to suggest that placing a collagen membrane over a bone grafting material in an infrabony defect of more than 270 degrees is more effective than placing the bone graft material alone. The present study will help in understanding if such defects require an additional placement of a collagen membrane which could increase the cost of the procedure for the practitioner and the patient.
The study will be conducted at the University of Pittsburgh School of Dental Medicine Graduate Periodontics Department. A detailed description of research activities during each patient visit is provided below.
Screening Visit (V0):
Prior to starting any of the procedures, the subject will complete the informed consent interview. Patients will be screened to assess for inclusion in the study. Vitals (blood pressure and heart rate) will be measured and medical history will be discussed. Limited field of view (FOV) cone beam computed tomography (CBCT) scan will be taken and examined prior to the study to determine the presence of a 270 degree circumferential boney defect for inclusion in the study. Probing pocket depths (PPD), plaque sites, mobility and bleeding on probing (BOP) are clinical measurements that will be completed. The visit will take approximately 1.5 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Pre-surgical phase (V1):
If the patient is eligible and willing to participate in the study following the screening visit, they will return for V1. Their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events from the previous visit will be assessed. A periapical (PA) radiograph will be taken to confirm a crater like defect >=3mm. The prosthetic superstructures (implant crowns) will be removed followed by placement of cover screws. PPD will be measured twice (with and without the implant crown). Bleeding on Probing (BOP), suppuration, mobility, and plaque sites will be recorded. Clinical photographs will be taken of the teeth and inside of the mouth. Generalized supragingival debridement will be performed. Patients will be informed that newly fabricated crowns might be needed after the treatment as part of the study. During this visit, patients will be also re-instructed and emphasized on maintaining proper at-home oral hygiene measures with a soft-bristled toothbrush for minimizing trauma to marginal soft tissues. The visit will take approximately 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Surgical treatment procedures (V2) After 4 to 6 weeks, the patient will undergo regenerative surgical procedure. Their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. The Study individuals will receive a local anesthetic as needed by the surgeon. Intra-sulcular, and if necessary, vertical releasing incisions will be made. Soft tissue flaps will be elevated at buccal and lingual aspects providing adequate access. Granulation tissue and mineralized deposits at implants will be removed using titanium curettes. The implant surfaces will be decontaminated with airflow. Once the surgical site was debrided, clinical intra-surgical measurements will be made. The measurement of peri-implant defect depth will be made clinically intra-surgically. Defects will be measured by calibrated examiners using a periodontal probe. The depth will be measured to the deepest point of the defect. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) - (Measurement at re-entry procedure). The defect resolution (DR) on the other hand will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth. The horizontal defect, width of keratinized tissue, and soft tissue thickness will also be measured at this visit.
Thereafter, study individuals will be randomized to control or test groups using the SPSS randomization method (SPSS PASW 23.0 statistical software package, SPSS Inc., Armonk, NY, USA). Depending on the randomization, one of the following therapies was used: (a) (control group); bone grafting alone (InterOss Collagen) will be placed. (b) (test group); the intraosseous component will be filled with bone grafting (InterOss Collagen) and covered with a resorbable collagen membrane (InterCollagen Guide). InterOss Collagen is an FDA cleared for use in guided bone regenerative procedures. InterOss Collagen is a bovine derived anorganic hydroxyapatite collagen composite composed of 90% bovine granules and 10% collagen fibers molded in a block form. InterCollagen Guide is an FDA cleared porcine derived resorbable collagen membrane intended for periodontal and dental surgeries. In both groups, if needed, a periosteal releasing incision will be made to allow complete coverage of the wound area. In both study groups, surgical soft tissue flaps will be sutured with interrupted sutures without tissue tension using 4/0 or 5/0 PGA providing full wound closure. Clinical photographs will be taken again, and surgical video may be recorded when possible. All study individuals will receive postoperative antibiotics and prescribed post-operative pain relievers, as well as care instructions.
The postoperative medications may include:
Amoxicillin 500 mg 3 x 7 days
- Clindamycin 300 mg 4 x 7 days Ibuprofen 600 mg PRN Chlorhexidine 0.12% rinse 2 x 2 weeks Tylenol 3 (300mg-30mg)* Medrol Dose Pack (as needed) Instructions not to wear any removable prosthesis during the healing phase
- Administer if drug allergy to Amoxicillin *Administer as alternative to Ibuprofen
The visit will take approximately 2.5-3 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
4 weeks post op (V3) After 4 weeks (± 2 days), the patient will return for follow-up. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Sutures will be removed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Re-entry procedure and replacement of superstructures (healing abutment) (V4) After 4 months of uninterrupted healing, patients will return for the re-entry procedure. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. A standardized PA radiograph will be taken at this visit. Intrasulcular incision will be performed on the adjacent teeth and midcrestal incision at the implant location. Full thickness flap will be elevated, and the same defect measurements taken during the surgical procedures will be performed to obtain clinical changes in peri-implant bone levels. Where the defect fill will be measured as the difference in millimeters between the initial measurements taken at baseline and the depth of defect present at follow up. During the re-entry procedure, if the bone defect around the implant is not completely filled after V2, (it happens that we succeed to feel 60-70% of the defect, but not the whole defect), additional bone grafting material will be added after taking intra-surgical measurements. Please note the same bone graft material will be used, and will not involve additional clinical procedures, since the flap is open for the re-entry procedures. The outcome of "complete bone fill?" Yes/No will be recorded on the Visit form. Then, implant cover screws will be replaced by appropriate healing abutments, followed by single interrupted sutures for re-adaptation of the flap. Clinical photographs will be taken again, and surgical video may be recorded. Finally, a periodontal maintenance will be performed. The visit will take approximately 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident. During this period, if needed new crowns will be designed, fabricated, and delivered to all patients and for all treated implants.
Post op after stage 2 (V5) Approximately 2 weeks after V4, subjects will return for V5. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Sutures will be removed. If a new crown is needed, digital impression will be taken with the Trios hand-held scanner, and patient will be referred to receive a new crown. If no new crown is needed, the old crown will be replaced at the next visit. Clinical photographs will be taken again. The visit will take approximately 1-2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Crown placement/replacement (V6) Approximately 1 month after V5, the subjects will return for the Implant Crown replacement. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. The old crown or the new crown will be placed in the treated area. A radiograph may be taken to assist in placement. The visit will take approximately 1- 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
8 months visit (V7) For V7, subjects will return at approximately 8-months post-op. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Probing pocket depth (PPD), recession, BOP, plaque, suppuration and mobility measurement will be recorded. Radiographic measurements (bone fill) will be obtained as performed at the pre-surgical visit (time point 1). Dental prophylaxis and periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
12 months visit (V8) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the pre-surgical visit (time point 1) using a standardized PA radiograph. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 2:
15, 18, 21, 24 months visit (V9, V10, V11, V12) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V12, timepoint 24 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 3:
27, 30, 33, 36 months visit (V13, V14, V15, V16) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V16, timepoint 36 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 4:
39, 42, 45, 48 months visit (V17, V18, V19, V20) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V20, timepoint 48 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Year 5:
51, 54, 57, 60 months visit (V21, V22, V23, V24) Any changes to subject's medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visits will be assessed. Probing pocket depth (PPD), recession, BOP, suppuration, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the last visit (V24, timepoint 60 months) using a standardized PA radiograph. If a patient is pregnant, the periapical x-ray will not be performed. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Clinical measurements:
- The following baseline procedures will be performed; (a) Intra-oral photographs and intra-oral radiographs of the implant sites; (b) clinical recording of full mouth plaque scores (FMPS) (presence of dental plaque along the peri-implant mucosal margin (gingival margin at teeth) was expressed as a percentage of examined sites within each subject including four sites per tooth and implant, (c) clinical recording of local plaque score (LPS) (presence of dental plaque along the mucosal margin at four sites of each treated implant and expressed as a percentage of implant sites within each subject), (d) clinical recording of probing pocket depths (PPD) (at all teeth, and the specific implant in the study (four sites; implant/tooth) to the nearest millimeter with a North Carolina probe (e) clinical recording of full mouth bleeding scores calculated as the percentage of assessed surfaces with BOP, (f) BOP will also be assessed with the North Carolina probe at four sites per implant. The bleeding will be graded; 0 = no bleeding, 1 = dot of bleeding, 2 = line of bleeding and 3 = drop of bleeding (Mombelli, van Oosten, Schurch, \& Lang, 1987), (g) clinical recording of recession at the peri-implant mucosal margin (buccal/lingual-palatal) relative to a fixed reference point on implants and (h), clinical recording of presence/absence of suppuration (SUP) at the implant (4 sites/implant).
- Peri-implant defect depth will be made clinically intra-surgically. Defects will be measured by calibrated examiners using a periodontal probe. The depth will be measured to the deepest point of the defect. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) - (Measurement at re-entry procedure). The defect resolution (DR) will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth.
- MBL will be calculated based on standardized radiographs using registered bite-block with a Rinn (Dentsply Rinn, Elgin, IL, USA) film holder and expressed as the distance from the implant shoulder to the most coronal bone-to-implant contact (BIC) on the mesial and distal side of the implant. The mean values will be calculated for each implant. In the case that the bone levels around the study implants are hidden or difficult to read, new radiographs will be taken. Peri-implant marginal bone levels will be measured using the ImageJ software* (ImageJ, U. S. National Institutes of Health, Bethesda, Maryland, USA) (Schneider, Rasband, \& Eliceiri, 2012). The software will be calibrated for every single image using the known implant length or the length of the implant collar. Measurements of the mesial and distal bone crest level adjacent to each implant will be rounded to the nearest 0.1 mm. Implants with bone up to the coronal margin of the implant collar will be given a value of zero. Mesial and distal measurements of each implant are averaged, and a mean calculated at patient level and then at group level. Implant failure: It will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0-mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study will be a parallel, randomized single center clinical trial where participants will be randomized in to 2 groups: treatment with or without resorbable collagen membrane.
| Arm | Type | Receives |
|---|---|---|
| Bone grafting with collagen membrane | Experimental | Procedure: InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane)This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with a collagen membrane (InterCollagen Guide) placed over the bone graft. |
| Bone grafting without collagen membrane | Active comparator | Procedure: InterOss Collagen (Bone xenograft)This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with no collagen membrane placed over the graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane)Group will receive InterOss Collagen and InterOss Collagen Guide during surgical intervention visit. | Procedure or surgery | Bone grafting with collagen membrane |
| InterOss Collagen (Bone xenograft)Group will only receive InterOss Collagen during surgical intervention visit. | Procedure or surgery | Bone grafting without collagen membrane |
Primary outcome
Successful Treatment of Peri-Implantitis
Time frame: 1 year
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 12 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
Time frame: 2 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 24 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
Time frame: 3 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 36 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
Time frame: 4 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 48 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
Time frame: 5 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 60 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
10 secondary outcomes
Radiographic Marginal Bone Loss (MBL)
Time frame: 8 months
Radiographic Marginal Bone Loss (MBL)
Time frame: 12 months
Peri-Implant Bleeding on Probing
Time frame: 8 months
Peri-Implant Bleeding on Probing
Time frame: 12 months
Peri-Implant Probing Depth
Time frame: 8 months
Peri-Implant Probing Depth
Time frame: 12 months
Clinical Peri-Implant Bone Defect Fill
Time frame: 4 months
Clinical Peri-Implant Bone Defect Resolution
Time frame: 4 months
Patient Reported Pain Outcomes
Time frame: 2 weeks
Patient Reported Pain Outcomes
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Research study data will be stored separately from medical records. Consent forms and copies of letters/correspondence will be stored separately from the research data. Data will be coded with a participant code number which will be assigned consecutively as subjects are enrolled. There will be an excel spreadsheet containing the linkage code to the identifiable patient name or Axium number. This spreadsheet will be password protected and only accessible to the research team and will be saved in a separate location then the medical records (such as OneDrive). De-identified research data will be shared with the sponsor and may be shared with other researchers studying similar conditions. In any publication of this data, confidentiality of individual subjects will be protected. De-identified data may be shared with other researchers or federal repositories in the future under an approved sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Ravida, DDS MS PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane) and InterOss Collagen (Bone xenograft) in people with Peri-Implantitis and Surgery, run by Andrea Ravida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Treatment of Peri-Implantitis (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.