Peri-implantitisNCT06957652
Reconstructive Treatment of Peri-implantitis With Combined Defects
A study testing DBMM-C plus Resorbable collagen membrane and DBMM-C in people with Peri-implantitis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized clinical study is to assess the additional clinical benefit of incorporating a resorbable collagen membrane (CM) alongside a xenogeneic bone graft-specifically, deproteinized bovine bone mineral with 10% collagen (DBBM-C)-in the reconstructive surgical treatment of peri-implantitis involving… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- DBMM-C plus Resorbable collagen membrane and DBMM-C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Dec 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Peri-implantitis defined as the presence of a peri-implant probing pocket depth (PPD) ≥6 mm with bleeding and/or suppuration on probing (BoP/SoP) and radiographic marginal bone loss (MBL) ≥3 mm.
- Presence of combined defect configuration Class [Ib, Ic, Ie with horizontal components (i.e. Class II) (Schwarz et al., 2010)] with an intrabony compartment of ≥3 mm.
- Presence of a minimum width of 2 mm of keratinized peri-implant mucosa on the buccal aspect of the implant.
- Implants placed in proper position (inside the bony housing)
- Having an implant-supported prosthesis that allows for adequate oral hygiene procedures and peri-implant probing.
Who cannot join
- Full-mouth plaque score (FMPS) < 25%
- Full-mouth bleeding score (FMBS) < 25%
- Cigarette smoking < 10 cig./day,
- Diagnosed with active periodontal disease,
- Having acute or chronic medical conditions or undergoing medications, such as intravenous amino-bisphosphonates, immunosuppressive drugs, and chemotherapy, that could interfere with the treatment outcome,
- Receiving antibiotic treatment in the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Faculty of Dentistry
Ankara, Turkey, 06490
Sila Cagri Isler, +903122034232, silaisler@gazi.edu.tr
About this study
Official title: Reconstructive Treatment of Combined Peri-implantitis-related Defects With or Without Collagen Membrane: A Randomized Clinical Study
The aim of this randomized clinical study is to assess the additional clinical benefit of incorporating a resorbable collagen membrane (CM) alongside a xenogeneic bone graft-specifically, deproteinized bovine bone mineral with 10% collagen (DBBM-C)-in the reconstructive surgical treatment of peri-implantitis involving combined (i.e., contained and non-contained) defect configurations.
Accordingly, the study addresses the following research questions:
- Does the adjunctive use of a CM in combination with DBBM-C improve treatment success compared to DBBM-C alone in the management of combined peri-implantitis-related defects?
- Does the combined use of a CM and DBBM-C lead to superior patient-reported outcomes (PROs) compared to the use of DBBM-C alone in the reconstructive treatment of such defects? A total of 60 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive test (DBMM-C +CM) or control group (DBMM-C) treatments. Clinical parameters will be assessed at baseline (i.e., prior to surgery), and at the 6-, and 12-month post-operatively. Radiographic examinations will be carried out at baseline and 12 months post-operatively. Patient oral health related to the treatment procedures will be evaluated using a written questionnaire [Oral Health Impact Profile (OHIP-14)] prior to treatment and after 2 weeks, 1, and 12 months following surgical therapy. Regarding post-treatment pain and overall patient satisfaction with treatment modalities, responses will be scored on a visual analog scale (VAS, 100 mm).
Read the detailed description
Reconstructive surgical therapy for peri-implantitis has shown improved clinical and radiographic outcomes, with favorable postoperative mucosal margin levels and superior radiographic bone fill compared to other treatment modalities. However, no specific biomaterial or application technique has yet been identified as clearly superior. In particular, the potential added value of combining a barrier membrane with a bone substitute, as opposed to using bone substitute alone, remains a subject of ongoing debate.
Recent studies have suggested that the adjunctive use of a barrier membrane does not necessarily enhance clinical or radiographic outcomes in peri-implantitis-associated intrabony defects. However, these studies often included heterogeneous defect morphologies, which may influence the regenerative potential and confound treatment outcomes.
Indeed, "contained" and "non-contained" defects may behave differently due to biological factors such as space maintenance, clot stability, and wound protection. his highlights the need to tailor biomaterial selection to the specific defect configuration. While current evidence suggests that barrier membranes may not provide additional benefit in fully contained defects, there is a lack of data regarding their effectiveness in combined defects that include both supracrestal and intrabony components, particularly those with partially contained 2- or 3-wall morphologies.
Therefore, the primary aim of this randomized clinical study is to evaluate the additional clinical benefit of incorporating a resorbable CM with DBMM-C in the reconstructive surgical treatment of peri-implantitis with combined defect morphology.
The secondary objective is to assess patient-reported outcomes (PROs) in both treatment groups.
- Conditions
- Peri-implantitis
- Being tested
- DBMM-C plus Resorbable collagen membrane, DBMM-C
- Keywords
- Reconstructive therapy, peri-implantitis, Bone defect, barrier membrane
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBMM-C plus Resorbable collagen membraneDevice
A trapezoidal flap design will be employed, including a sulcular incision and vertical releasing incisions extending approximately 2-3 mm beyond the mucogingival junction. Flap advancement will be facilitated through a periosteal-releasing incision at the flap base. Granulation tissue will be removed using a titanium curette, and implant surface decontamination will be performed with a titanium brush. The graft material will be placed in both supra- and intrabony defect components, followed by coverage with a resorbable collagen membrane. The flaps will then be coronally advanced and stabilized over the biomaterials.
DBMM-CDevice
A trapezoidal flap design will be employed, including a sulcular incision and vertical releasing incisions extending approximately 2-3 mm beyond the mucogingival junction. Flap advancement will be facilitated through a periosteal-releasing incision at the flap base. Granulation tissue will be removed using a titanium curette, and implant surface decontamination will be performed with a titanium brush. The graft material will be placed in both supra- and intrabony defect components, and then the flaps will be coronally advanced and stabilized over the graft material.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Reconstructive surgical therapy of combined peri-implantitis defects using a resorbable collagen membrane and DBMM-C. Receives: Device: DBMM-C plus Resorbable collagen membrane |
| Control group | Active comparator | Reconstructive surgical therapy of combined peri-implantitis defects using only DBMM-C. Receives: Device: DBMM-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment success (%)
The absence of bleeding on probing (BOP) at more than one site, no suppuration, deepest PPD ≤5mm, and no further radiographic bone loss.
Measured: 12 months after the surgical treatment
Secondary outcomes (5)
Percentage of bleeding on probing (BOP) (%)
The percentage of BOP around six sites of the implant
Measured: 12 months after the surgical treatment
Probing pocket depth (PPD)
The distance between the bottom of the pocket and the mucosal margin around the implant
Measured: 12 months after the surgical treatment
Change in radiographic vertical defect depth
Marginal bone levels (MBL) will be assessed the distance between this line and the first bone-to-implant contact (BIC). The mesial and distal measurements will be averaged for further calculations. The radiographic vertical defect depth changes over time will be evaluated the difference between MBL at baseline and 12 months following the therapy.
Measured: 12 months after the surgical treatment
Patient morbidity - Postoperative pain
Postoperative pain will be assessed using a visual analogue score
Measured: At baseline and after 2 weeks and 1 and 12 months following surgical treatment
Patient-reported satisfaction with the overall treatment
Patient-reported satisfaction will be assessed using a visual analogue score
Measured: At baseline and after 2 weeks and 1 and 12 months following surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Apr 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957652
- Sponsor's protocol ID
- 2024-KAEK-27/04
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Regidor E, Ortiz-Vigon A, Romandini M, Dionigi C, Derks J, Sanz M. The adjunctive effect of a resorbable membrane to a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis: A randomized clinical trial. J Clin Periodontol. 2023 Jun;50(6):765-783. doi: 10.1111/jcpe.13796. Epub 2023 Mar 6.
PubMed 36802084Schwarz F, Becker K, Albrecht C, Ramanauskaite A, Begic A, Obreja K. Effectiveness of modified and control protocols for the surgical therapy of combined peri-implantitis-related defects. A retrospective analysis. Clin Oral Implants Res. 2023 May;34(5):512-520. doi: 10.1111/clr.14057. Epub 2023 Mar 10.
PubMed 36852537Raabe C, Cafferata EA, Couso-Queiruga E, Chappuis V, Ramanauskaite A, Schwarz F. Impact of Two Flap Advancement Techniques and Periosteal Suturing on Graft Displacement During Guided Bone Regeneration. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13434. doi: 10.1111/cid.13434.
PubMed 39815673
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Treatment of Combined Peri-implantitis-related Defects With or Without Collagen Membrane: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06957652
- Acronym / sponsor ID
- 2024-KAEK-27/04
- Conditions
- Peri-implantitis
- Keywords
- Reconstructive therapy, peri-implantitis, Bone defect, barrier membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 May 2025 (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 aim of this randomized clinical study is to assess the additional clinical benefit of incorporating a resorbable collagen membrane (CM) alongside a xenogeneic bone graft-specifically, deproteinized bovine bone mineral with 10% collagen (DBBM-C)-in the reconstructive surgical treatment of peri-implantitis involving combined (i.e., contained and non-contained) defect configurations.
Accordingly, the study addresses the following research questions:
- Does the adjunctive use of a CM in combination with DBBM-C improve treatment success compared to DBBM-C alone in the management of combined peri-implantitis-related defects?
- Does the combined use of a CM and DBBM-C lead to superior patient-reported outcomes (PROs) compared to the use of DBBM-C alone in the reconstructive treatment of such defects? A total of 60 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive test (DBMM-C +CM) or control group (DBMM-C) treatments. Clinical parameters will be assessed at baseline (i.e., prior to surgery), and at the 6-, and 12-month post-operatively. Radiographic examinations will be carried out at baseline and 12 months post-operatively. Patient oral health related to the treatment procedures will be evaluated using a written questionnaire [Oral Health Impact Profile (OHIP-14)] prior to treatment and after 2 weeks, 1, and 12 months following surgical therapy. Regarding post-treatment pain and overall patient satisfaction with treatment modalities, responses will be scored on a visual analog scale (VAS, 100 mm).
Detailed description
Reconstructive surgical therapy for peri-implantitis has shown improved clinical and radiographic outcomes, with favorable postoperative mucosal margin levels and superior radiographic bone fill compared to other treatment modalities. However, no specific biomaterial or application technique has yet been identified as clearly superior. In particular, the potential added value of combining a barrier membrane with a bone substitute, as opposed to using bone substitute alone, remains a subject of ongoing debate.
Recent studies have suggested that the adjunctive use of a barrier membrane does not necessarily enhance clinical or radiographic outcomes in peri-implantitis-associated intrabony defects. However, these studies often included heterogeneous defect morphologies, which may influence the regenerative potential and confound treatment outcomes.
Indeed, "contained" and "non-contained" defects may behave differently due to biological factors such as space maintenance, clot stability, and wound protection. his highlights the need to tailor biomaterial selection to the specific defect configuration. While current evidence suggests that barrier membranes may not provide additional benefit in fully contained defects, there is a lack of data regarding their effectiveness in combined defects that include both supracrestal and intrabony components, particularly those with partially contained 2- or 3-wall morphologies.
Therefore, the primary aim of this randomized clinical study is to evaluate the additional clinical benefit of incorporating a resorbable CM with DBMM-C in the reconstructive surgical treatment of peri-implantitis with combined defect morphology.
The secondary objective is to assess patient-reported outcomes (PROs) in both treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Device: DBMM-C plus Resorbable collagen membraneReconstructive surgical therapy of combined peri-implantitis defects using a resorbable collagen membrane and DBMM-C. |
| Control group | Active comparator | Device: DBMM-CReconstructive surgical therapy of combined peri-implantitis defects using only DBMM-C. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Peri-implantitis defined as the presence of a peri-implant probing pocket depth (PPD) ≥6 mm with bleeding and/or suppuration on probing (BoP/SoP) and radiographic marginal bone loss (MBL) ≥3 mm.
- Presence of combined defect configuration Class [Ib, Ic, Ie with horizontal components (i.e. Class II) (Schwarz et al., 2010)] with an intrabony compartment of ≥3 mm.
- Presence of a minimum width of 2 mm of keratinized peri-implant mucosa on the buccal aspect of the implant.
- Implants placed in proper position (inside the bony housing)
- Having an implant-supported prosthesis that allows for adequate oral hygiene procedures and peri-implant probing.
Key exclusion criteria (6 listed)
- Full-mouth plaque score (FMPS) < 25%
- Full-mouth bleeding score (FMBS) < 25%
- Cigarette smoking < 10 cig./day,
- Diagnosed with active periodontal disease,
- Having acute or chronic medical conditions or undergoing medications, such as intravenous amino-bisphosphonates, immunosuppressive drugs, and chemotherapy, that could interfere with the treatment outcome,
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 |
|---|---|---|
| DBMM-C plus Resorbable collagen membraneA trapezoidal flap design will be employed, including a sulcular incision and vertical releasing incisions extending approximately 2-3 mm beyond the mucogingival junction. Flap advancement will be facilitated through a periosteal-releasing incision at the flap base. Granulation tissue will be removed using a titanium curette, and implant surface decontamination will be performed with a titanium brush. The graft material will be placed in both supra- and intrabony defect components, followed by coverage with a resorbable collagen membrane. The flaps will then be coronally advanced and stabilized over the biomaterials. | Device | Test Group |
| DBMM-CA trapezoidal flap design will be employed, including a sulcular incision and vertical releasing incisions extending approximately 2-3 mm beyond the mucogingival junction. Flap advancement will be facilitated through a periosteal-releasing incision at the flap base. Granulation tissue will be removed using a titanium curette, and implant surface decontamination will be performed with a titanium brush. The graft material will be placed in both supra- and intrabony defect components, and then the flaps will be coronally advanced and stabilized over the graft material. | Device | Control group |
Primary outcome
Percentage of treatment success (%)
Time frame: 12 months after the surgical treatment
The absence of bleeding on probing (BOP) at more than one site, no suppuration, deepest PPD ≤5mm, and no further radiographic bone loss.
5 secondary outcomes
Percentage of bleeding on probing (BOP) (%)
Time frame: 12 months after the surgical treatment
Probing pocket depth (PPD)
Time frame: 12 months after the surgical treatment
Change in radiographic vertical defect depth
Time frame: 12 months after the surgical treatment
Patient morbidity - Postoperative pain
Time frame: At baseline and after 2 weeks and 1 and 12 months following surgical treatment
Patient-reported satisfaction with the overall treatment
Time frame: At baseline and after 2 weeks and 1 and 12 months following surgical treatment
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 4 May 2025.
- Background: PubMed 36802084Regidor E, Ortiz-Vigon A, Romandini M, Dionigi C, Derks J, Sanz M. The adjunctive effect of a resorbable membrane to a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis: A randomized clinical trial. J Clin Periodontol. 2023 Jun;50(6):765-783. doi: 10.1111/jcpe.13796. Epub 2023 Mar 6.
- Background: PubMed 36852537Schwarz F, Becker K, Albrecht C, Ramanauskaite A, Begic A, Obreja K. Effectiveness of modified and control protocols for the surgical therapy of combined peri-implantitis-related defects. A retrospective analysis. Clin Oral Implants Res. 2023 May;34(5):512-520. doi: 10.1111/clr.14057. Epub 2023 Mar 10.
- Background: PubMed 39815673Raabe C, Cafferata EA, Couso-Queiruga E, Chappuis V, Ramanauskaite A, Schwarz F. Impact of Two Flap Advancement Techniques and Periosteal Suturing on Graft Displacement During Guided Bone Regeneration. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13434. doi: 10.1111/cid.13434.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBMM-C plus Resorbable collagen membrane and DBMM-C in people with Peri-implantitis, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 Turkey (Türkiye). 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?
Contact Sila Cagri Isler, PhD (+905069966074, silaisler@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treatment success (%) (time frame: 12 months after the surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06957652, which also lists 3 linked publications.
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 4 May 2025.