DehiscenceNCT07580495
Effect of Collagen Membrane on Ridge Preservation
A study testing Minimally Invasive tooth extraction, Alveolar ridge preservation with ABCC and Resorbable collagen membrane (InterCollagen® Guide) in people with Dehiscence and Tooth Extraction, run by Debora Dias at 1 site in United States.
Trial summary
This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dehiscence, Tooth Extraction, Alveolar Bone Loss
- What is being tested?
- Minimally Invasive tooth extraction, Alveolar ridge preservation with ABCC and Resorbable collagen membrane (InterCollagen® Guide)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 31 Oct 2027
- Phase
- Interventional
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80
- Indicated for extraction of a single-rooted maxillary tooth
- ≥ 30% buccal bone dehiscence confirmed by CBCT reconstructions
- Presence of both adjacent teeth
- No interproximal bone loss
- ASA I-II health status
- Ability to comply with required procedures, including attending required number of clinic visits
Who cannot join
- Patients diagnosed with periodontitis adjacent to the area to be treated
- History of allergic reactions to local anesthetics or bone graft material (self-reported);
- Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
- Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
- Presence of active infectious diseases of any kind;
- History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
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- Severe hematologic disorders (risk for hemorrhage)(self-reported);
- Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
- Any history of alcohol or drug abuse (self-reported);
- Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);
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, 1 recruiting
- Recruiting
University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
Pittsburgh, Pennsylvania, 15213
Debora R Dias, DDS, PhD, 4126488595, deboradias@pitt.edu
Andrea Ravida, DDS, PhD, 7347309678, andrearavida@pitt.edu
About this study
Official title: Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial
This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement.
Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans.
The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.
Read the detailed description
This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants.
Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it.
Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement.
During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing.
The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.
- Conditions
- Dehiscence, Tooth Extraction, Alveolar Bone Loss
- Being tested
- Minimally Invasive tooth extraction, Alveolar ridge preservation with ABCC, Resorbable collagen membrane (InterCollagen® Guide)
- Keywords
- Ridge preservation, Collagen membrane, Socket grafting, Buccal bone loss, Delayed implant placement
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive tooth extractionProcedure or surgery
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
Alveolar ridge preservation with ABCCDevice
The extraction socket will be grafted with ABCC (SigmaGraft®).
Resorbable collagen membrane (InterCollagen® Guide)Device
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.
| Study group | Role | What they receive |
|---|---|---|
| Control group (bone graft only) | Active comparator | Control group (bone graft only): The socket will be grafted with ABCC alone. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure. Receives: Procedure: Minimally Invasive tooth extraction; Device: Alveolar ridge preservation with ABCC |
| Test group (bone graft + collagen membrane) | Experimental | Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft). The socket will then be grafted with ABCC. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure. Receives: Procedure: Minimally Invasive tooth extraction; Device: Alveolar ridge preservation with ABCC; Device: Resorbable collagen membrane (InterCollagen® Guide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal dimensional changes (%)
Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Measured: Baseline and 4 months
Secondary outcomes (15)
Horizontal dimensional changes (%)
Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Measured: Baseline and 4 months
Horizontal dimensional changes (%)
Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Measured: Baseline and 4 months
Vertical dimensional changes (%)
Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
Measured: Baseline and 4 months
Vertical dimensional changes (%)
Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
Measured: Baseline and 4 months
Volumetric dimensional changes (%)
Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change.
Measured: Baseline and 4 months
Mid-buccal soft tissue contour change (mm)
Linear measurement (mm) of mid-buccal soft tissue profile change assessed by superimposition of stereolithography (STL) datasets. Adjacent teeth are used as reference for alignment. A positive value indicates soft tissue gain; a negative value indicates recession.
Measured: Baseline and 4 months
Mid-buccal soft tissue volume change (%)
Volumetric change (mm³) in mid-buccal soft tissue contour calculated by superimposition of STL datasets and expressed in percentage. Color-coded deviation maps will illustrate areas of soft tissue collapse or gain.
Measured: Baseline and 4 months
Interproximal papilla height change (mm)
Linear measurement (mm) of interproximal papilla height change assessed by superimposition of STL datasets in comparison to baseline. A positive value indicates papilla gain; a negative value indicates papilla loss.
Measured: Baseline and 4 months
Wound healing (Wound Healing Index)
Wound healing quality assessed using the Wound Healing Index (WHI), a 3-point ordinal scale where 1 = uneventful healing (complete soft tissue coverage, no complications), 2 = normal healing with minor complications, and 3 = poor healing (dehiscence, exposure, or infection requiring intervention). Lower scores indicate better healing.
Measured: 1 week, 2 weeks, 1 month, 4 months
Incidence of postoperative complications (Percentage)
Proportion of participants experiencing at least one postoperative complication (edema, erythema, suppuration, graft exposure, or wound dehiscence) at any follow-up visit. Complications will be recorded by a blinded clinical examiner at each scheduled visit.
Measured: 1 week, 2 weeks, 1 month, 4 months
Postoperative pain
Numeric scale (0-10) for pain after the extraction and ridge preservation procedure.
Measured: Day 1, Day 3, 1 week
Oral health-related quality of life (OHIP-14)
Oral health-related quality of life assessed using the Oral Health Impact Profile - 14 (OHIP-14), a validated 14-item questionnaire.
Measured: Baseline, 2 weeks, 4 months
Feasibility of prosthetically ideal implant placement without additional augmentation
Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation.
Measured: 4 months
Histological Outcomes
In a subset of patients, a bone core biopsy will be obtained. Percent area of new bone, residual graft, and marrow spaces assessed by histomorphometric analysis of bone core biopsies obtained at the time of implant placement.
Measured: 4 months
Patient satisfaction (VAS)
Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start26 May 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DehiscenceStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debora Dias
- Sponsor type
- University, hospital or other
- Collaborators
- SigmaGraft Inc.
- Responsible party
- Sponsor-investigator, Debora Dias, University of Pittsburgh
- Investigators
- Debora R Dias, DDS, PhD, Principal investigator, University of Pittsburgh, Department of Periodontics and Preventive Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580495
- Sponsor's protocol ID
- STUDY25080006
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared outside the primary research group due to concerns regarding participant privacy and confidentiality, as approved by the University of Pittsburgh Institutional Review Board.
Publications
Hutton CG, Johnson GK, Barwacz CA, Allareddy V, Avila-Ortiz G. Comparison of two different surgical approaches to increase peri-implant mucosal thickness: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):807-814. doi: 10.1002/JPER.17-0597. Epub 2018 Jul 20.
PubMed 29633268Natto ZS, Parashis A, Steffensen B, Ganguly R, Finkelman MD, Jeong YN. Efficacy of collagen matrix seal and collagen sponge on ridge preservation in combination with bone allograft: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jun;44(6):649-659. doi: 10.1111/jcpe.12722. Epub 2017 May 26.
PubMed 28303642Tonetti MS, Sanz M, Avila-Ortiz G, Berglundh T, Cairo F, Derks J, Figuero E, Graziani F, Guerra F, Heitz-Mayfield L, Jung RE, Lai H, Needleman I, Papapanou PN, Sailer I, Sanz-Sanchez I, Schwarz F, Shi J, Thoma D. Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report. J Clin Periodontol. 2023 May;50 Suppl 25:5-21. doi: 10.1111/jcpe.13808. Epub 2023 May 4.
PubMed 37143289Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
PubMed 27310522Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x.
PubMed 22211304Barone A, Toti P, Quaranta A, Alfonsi F, Cucchi A, Calvo-Guirado JL, Negri B, Di Felice R, Covani U. Volumetric analysis of remodelling pattern after ridge preservation comparing use of two types of xenografts. A multicentre randomized clinical trial. Clin Oral Implants Res. 2016 Nov;27(11):e105-e115. doi: 10.1111/clr.12572. Epub 2015 Feb 26.
PubMed 25727443Avila-Ortiz G, Couso-Queiruga E, Stuhr S, Chambrone L. Long-term outcomes of post-extraction alveolar ridge preservation and alveolar ridge reconstruction followed by delayed implant placement: A systematic review. Periodontol 2000. 2025 Jul 3. doi: 10.1111/prd.12642. Online ahead of print.
PubMed 40605823Araujo MG, Dias DR, Matarazzo F. Anatomical characteristics of the alveolar process and basal bone that have an effect on socket healing. Periodontol 2000. 2023 Oct;93(1):277-288. doi: 10.1111/prd.12506. Epub 2023 Aug 2.
PubMed 37533162Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354