Maxillary SinusNCT02170129
SINUS LIFT 100% Anorganic Bovine Bone vs. 50% Anorganic Bovine Bone + 50% Autologous Bone
A study testing 50% AAB plus 50% autologous bone and 100% AAB in people with Maxillary Sinus and Dental Implants, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Sinus, Dental Implants
- What is being tested?
- 50% AAB plus 50% autologous bone and 100% AAB
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Need for implant-supported prosthesis in maxillary posterior area.
- Need to insert implant in atrophic posterior maxilla, with a residual alveolar bone height 1 4 mm.
- ≥ 18 years of age.
- Provided written informed consent.
- Smokers of fewer than 10 cigarettes per day.
- Absence of sinus cyst or active sinusitis.
Who cannot join
- General contraindications to implant surgery.
- Occluding dentition in the area intended for implant installation
- Periodontitis.
- Bruxism.
- Immunosuppression.
- Previous history of irradiation of the head and neck area.
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- Uncontrolled diabetes.
- Heavy smoker (>10 cigarettes/day).
- Poor oral hygiene.
- Current or past treatment with bisphosphonates.
- Substance abuse.
- Psychiatric disorder.
- Inability to complete follow-up ≥1 year.
- Lactation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Scienze chirurgiche microchirurgiche e mediche dell'università degli studi di sassari
Sassari, SS, 07100
About this study
Official title: Sinus Lift Grafting With Anorganic Bovine Bone vs 50% Autologous + 50% Bovine Bone. One Year Results From a Randomized Controlled Trial.
Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are available that can overcome the limitations of autologous bone due to their osteoconductive properties and biocompatibility. Several studies seem to validate these concepts, but further comparative trials are needed.
Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.
Material and Methods: This study was designed as a randomised, controlled, clinical trial. Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses were randomised according to a parallel group design. Sinuses were grafted according to a lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss) and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same surgical procedure a sample of bone was harvested for histomorphometric analysis . All implants were delayed loaded with screw retained temporary crowns 3 months after implants insertion and with screw retained definitive crowns 4 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation.
- Conditions
- Maxillary Sinus, Dental Implants
- Being tested
- 50% AAB plus 50% autologous bone, 100% AAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% AAB plus 50% autologous boneDevice
Also called Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland, Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)
All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA).
A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later.
Both groups received tapered implants with an anodised surface.
100% AABDevice
Also called Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland, Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)
All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA).
A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later. Both groups received tapered implants with an anodised surface.
| Study group | Role | What they receive |
|---|---|---|
| 100% AAB | Active comparator | Surgical procedures were performed according to a lateral approach technique at the edentulous region distal to the position of the first premolar. A mucoperiosteal buccal flap was elevated, exposing the lateral bony wall of the sinus antrum. A round diamond bur, 2 mm in diameter, was used to outline the demarcation of the lateral window, which was removed, thus completely exposing the underlying Schneiderian membrane. The membrane was separated from the housing bone, and a tension-free reflection exposing the sinus walls was achieved by gently pushing it away using a large flat curette (Kramer-Nevins, Hu-Friedy, Chicago, IL). The established voids were then filled with 100% AAB (Bio-Oss) followed by sealing the open lateral window by the placement of a collagen membrane (Bio Gide) and primary soft tissue closure using Vicryl 4.0 sutures (Vicryl, Ethicon J\&J International, Sint-Stevens-Woluwe, Belgium). Receives: Device: 100% AAB |
| 50% AAB plus 50% autologous bone | Active comparator | Surgical procedures were performed according to a lateral approach technique at the edentulous region distal to the position of the first premolar. A mucoperiosteal buccal flap was elevated, exposing the lateral bony wall of the sinus antrum. A round diamond bur, 2 mm in diameter, was used to outline the demarcation of the lateral window, which was removed, thus completely exposing the underlying Schneiderian membrane. The membrane was separated from the housing bone, and a tension-free reflection exposing the sinus walls was achieved by gently pushing it away using a large flat curette (Kramer-Nevins, Hu-Friedy, Chicago, IL). The established voids were then filled with 50% AAB (Bio-Oss) plus 50% autologous bone harvested locally with a bone scraper followed by sealing the open lateral window by the placement of a collagen membrane (Bio Gide) and primary soft tissue closure using Vicryl 4.0 sutures (Vicryl, Ethicon J\&J International, Sint-Stevens-Woluwe, Belgium). Receives: Device: 50% AAB plus 50% autologous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMPLANT SURVIVAL
The removal of implants was dictated by instability, progressive marginal bone loss, infection, or implant fracture. The stability of individual implants was measured by the prosthodontist at the time of definitive crown delivery (5 months after implant placement) by applying 35 Ncm of removal torque. After 1 year, implant stability was tested manually with two dental mirror handles.
Measured: up to 12 months
Secondary outcomes (1)
MARGINAL BONE LEVELS
Peri-implant marginal bone levels were evaluated on intraoral digital radiographs taken with the parallel technique. A blinded radiologist (FG), unaffiliated with the study centre, interpreted all radiographs. The distances from the mesial and distal interproximal bone to the reference point (the horizontal interface between the implant and abutment) were measured with a software tool (NIH Scion Image, ver. 4.0.2, Frederick, MD, USA) calibrated against the space between two threads to the nearest 0.1 mm, and the mean of these two measurements was calculated for each implant. The measurements were recorded with reference to the implant axis.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Mario Meloni, Università degli Studi di Sassari
- Investigators
- Silvio M Meloni, DDS, Phd, MS, Principal investigator, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170129
- Sponsor's protocol ID
- SINUS LIFT
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Lift Grafting With Anorganic Bovine Bone vs 50% Autologous + 50% Bovine Bone. One Year Results From a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02170129
- Acronym / sponsor ID
- SINUS LIFT
- Conditions
- Maxillary Sinus, Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- First posted
- 23 Jun 2014 (estimated)
- 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.
Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are available that can overcome the limitations of autologous bone due to their osteoconductive properties and biocompatibility. Several studies seem to validate these concepts, but further comparative trials are needed.
Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.
Material and Methods: This study was designed as a randomised, controlled, clinical trial. Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses were randomised according to a parallel group design. Sinuses were grafted according to a lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss) and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same surgical procedure a sample of bone was harvested for histomorphometric analysis . All implants were delayed loaded with screw retained temporary crowns 3 months after implants insertion and with screw retained definitive crowns 4 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100% AAB | Active comparator | Device: 100% AABSurgical procedures were performed according to a lateral approach technique at the edentulous region distal to the position of the first premolar. A mucoperiosteal buccal flap was elevated, exposing the lateral bony wall of the sinus antrum. A round diamond bur, 2 mm in diameter, was used to outline the demarcation of the lateral window, which was removed, thus completely exposing the underlying Schneiderian membrane. The membrane was separated from the housing bone, and a tension-free reflection exposing the sinus walls was achieved by gently pushing it away using a large flat curette (Kramer-Nevins, Hu-Friedy, Chicago, IL). The established voids were then filled with 100% AAB (Bio-Oss) followed by sealing the open lateral window by the placement of a collagen membrane (Bio Gide) and primary soft tissue closure using Vicryl 4.0 sutures (Vicryl, Ethicon J\&J International, Sint-Stevens-Woluwe, Belgium). |
| 50% AAB plus 50% autologous bone | Active comparator | Device: 50% AAB plus 50% autologous boneSurgical procedures were performed according to a lateral approach technique at the edentulous region distal to the position of the first premolar. A mucoperiosteal buccal flap was elevated, exposing the lateral bony wall of the sinus antrum. A round diamond bur, 2 mm in diameter, was used to outline the demarcation of the lateral window, which was removed, thus completely exposing the underlying Schneiderian membrane. The membrane was separated from the housing bone, and a tension-free reflection exposing the sinus walls was achieved by gently pushing it away using a large flat curette (Kramer-Nevins, Hu-Friedy, Chicago, IL). The established voids were then filled with 50% AAB (Bio-Oss) plus 50% autologous bone harvested locally with a bone scraper followed by sealing the open lateral window by the placement of a collagen membrane (Bio Gide) and primary soft tissue closure using Vicryl 4.0 sutures (Vicryl, Ethicon J\&J International, Sint-Stevens-Woluwe, Belgium). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Need for implant-supported prosthesis in maxillary posterior area.
- Need to insert implant in atrophic posterior maxilla, with a residual alveolar bone height 1 4 mm.
- ≥ 18 years of age.
- Provided written informed consent.
- Smokers of fewer than 10 cigarettes per day.
Key exclusion criteria (14 listed)
- General contraindications to implant surgery.
- Occluding dentition in the area intended for implant installation
- Periodontitis.
- Bruxism.
- Immunosuppression.
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 |
|---|---|---|
| 50% AAB plus 50% autologous boneAlso: Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland, Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA). A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later. Both groups received tapered implants with an anodised surface. | Device | 50% AAB plus 50% autologous bone |
| 100% AABAlso: Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland, Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA). A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later. Both groups received tapered implants with an anodised surface. | Device | 100% AAB |
Primary outcome
IMPLANT SURVIVAL
Time frame: up to 12 months
The removal of implants was dictated by instability, progressive marginal bone loss, infection, or implant fracture. The stability of individual implants was measured by the prosthodontist at the time of definitive crown delivery (5 months after implant placement) by applying 35 Ncm of removal torque. After 1 year, implant stability was tested manually with two dental mirror handles.
1 secondary outcome
MARGINAL BONE LEVELS
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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. This study is not recruiting at the moment.
Silvio M Meloni, DDS, Phd, MS principal investigator
Università degli Studi di Sassari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% AAB plus 50% autologous bone and 100% AAB in people with Maxillary Sinus and Dental Implants, run by Università degli Studi di Sassari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Jun 2014. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IMPLANT SURVIVAL (time frame: up to 12 months). 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 23 Jun 2014.