Peri-implantitisCMAPINCT07478978
Collagen Membrane and Allograft in Peri-Implantitis Surgery
A study testing Collagen Membrane + Allograft and Allograft in people with Peri-implantitis and Guided Bone Regeneration, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Peri-implantitis is an inflammatory condition characterized by inflammation of the peri-implant tissues and progressive loss of supporting bone around dental implants. Surgical treatment is often required in advanced cases to decontaminate implant surfaces and manage peri-implant bone defects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peri-implantitis, Guided Bone Regeneration, Biochemical Markers
- What is being tested?
- Collagen Membrane + Allograft and Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2024to 15 Oct 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with peri-implantitis characterized by bleeding and/or suppuration on probing and increased probing depth around dental implants.
- Presence of circumferential intrabony peri-implant defects requiring reconstructive surgical treatment.
- Patients aged 18 years or older.
- Presence of functioning dental implants in the oral cavity.
- Patients who are able and willing to attend follow-up visits and provide informed consent.
Who cannot join
- Patients with uncontrolled systemic diseases that could affect wound healing.
- Use of antibiotics or anti-inflammatory drugs within the last 3 months.
- Pregnancy or lactation.
- Heavy smoking habits.
- Poor oral hygiene or lack of compliance with periodontal maintenance therapy.
- Previous surgical treatment for peri-implantitis at the study site.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Dentistry
Samsun, Atakum, 55200
About this study
Official title: Comparison of the Use of Collagen Membrane Combined With Allograft Versus Allograft Alone in the Surgical Treatment of Peri-Implantitis
Peri-implantitis is an inflammatory condition characterized by inflammation of the peri-implant tissues and progressive loss of supporting bone around dental implants. Surgical treatment is often required in advanced cases to decontaminate implant surfaces and manage peri-implant bone defects. Regenerative approaches frequently include the use of bone graft materials and barrier membranes to promote bone regeneration and improve healing outcomes.
The aim of this randomized clinical trial is to evaluate whether the adjunctive use of a resorbable collagen membrane provides additional benefits when combined with an allograft in the surgical treatment of peri-implantitis. A total of 44 patients diagnosed with peri-implantitis associated with circumferential intrabony defects are randomly allocated into two groups: one treated with allograft combined with a collagen membrane and the other treated with allograft alone.
Clinical parameters including probing depth, bleeding on probing, and suppuration are recorded at baseline and during follow-up. Radiographic marginal bone levels are assessed using standardized periapical radiographs. In addition, peri-implant crevicular fluid samples are collected to measure platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) levels as biochemical indicators of healing. The outcomes of the two treatment approaches are compared to determine whether the use of a collagen membrane provides additional clinical, radiographic, or biochemical benefits in peri-implantitis surgery.
Read the detailed description
Peri-implantitis is a plaque-associated pathological condition characterized by inflammation of the peri-implant mucosa and progressive loss of supporting bone around dental implants. Due to the structural differences between periodontal and peri-implant tissues, peri-implantitis lesions often show rapid progression and may require surgical intervention in advanced cases. Surgical therapy aims to eliminate the inflammatory lesion, decontaminate the implant surface, and manage peri-implant bone defects.
Regenerative surgical approaches have been proposed to reconstruct peri-implant bone defects and improve treatment outcomes. Bone graft materials are commonly used to provide an osteoconductive scaffold and promote new bone formation. In addition, barrier membranes may be used to stabilize the grafted area and prevent the migration of epithelial and connective tissue cells into the defect site. Resorbable collagen membranes are widely used because of their biocompatibility, resorbability, and ability to support wound stabilization during the healing process.
However, the adjunctive benefit of using a collagen membrane together with a bone graft in the surgical treatment of peri-implantitis remains controversial. Furthermore, limited data are available regarding the biological response associated with these regenerative procedures.
The present randomized clinical trial aims to evaluate the adjunctive effect of a resorbable collagen membrane used in combination with an allograft in the surgical treatment of peri-implantitis. A total of 44 patients diagnosed with peri-implantitis associated with circumferential intrabony defects are randomly assigned to one of two treatment groups: (1) allograft combined with a resorbable collagen membrane (test group) and (2) allograft alone (control group).
Clinical parameters including probing depth, bleeding on probing, and suppuration are recorded at baseline and during follow-up examinations. Radiographic marginal bone levels are evaluated using standardized periapical radiographs. In addition, peri-implant crevicular fluid samples are collected at baseline, 1 month, and 3 months to determine platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) levels using ELISA. These biochemical markers are analyzed to evaluate the biological healing response following surgical treatment.
The outcomes of the two treatment approaches are compared in terms of clinical, radiographic, and biochemical parameters in order to determine whether the use of a collagen membrane provides additional benefit in the reconstructive surgical treatment of peri-implantitis.
- Being tested
- Collagen Membrane + Allograft, Allograft
- Keywords
- Peri-implantitis, Collagen membrane, Allograft, PDGF, VEGF
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Membrane + AllograftProcedure or surgery
Also called Bone Allograft, Particulate Allograft
Reconstructive surgical treatment of peri-implantitis in which peri-implant bone defects are filled with particulate allograft and covered with a resorbable collagen membrane following implant surface decontamination and defect debridement.
AllograftProcedure or surgery
Also called Bone Allograft
Reconstructive surgical treatment of peri-implantitis in which peri-implant bone defects are filled with particulate allograft alone following implant surface decontamination and defect debridement, without the use of a collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| Allograft + Collagen Membrane | Experimental | Participants receive reconstructive surgical treatment for peri-implantitis using a particulate allograft alone without the use of a collagen membrane following implant surface decontamination and defect debridement. Receives: Procedure: Collagen Membrane + Allograft |
| Allograft Alone | Active comparator | Participants receive reconstructive surgical treatment for peri-implantitis using particulate allograft alone following implant surface decontamination and defect debridement. No collagen membrane is applied in this group. Receives: Procedure: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Depth (PD)
Change in peri-implant probing depth measured with a periodontal probe to evaluate the clinical effectiveness of reconstructive surgical treatment of peri-implantitis using allograft with or without a resorbable collagen membrane.
Measured: Baseline to 6 months after surgery
Change in Bleeding on Probing (BoP)
Change in bleeding on probing around dental implants used to evaluate peri-implant tissue inflammation following reconstructive surgical treatment.
Measured: Baseline to 6 months after surgery
Change in Suppuration on Probing
Change in the presence of suppuration around implants as an indicator of infection resolution after surgical treatment of peri-implantitis.
Measured: Baseline to 6 months after surgery
Change in Radiographic Marginal Bone Level
Radiographic evaluation of marginal bone levels around implants using standardized periapical radiographs to assess bone regeneration after reconstructive surgery.
Measured: Baseline to 6 months after surgery
Change in PDGF Levels in Peri-implant Crevicular Fluid
Evaluation of platelet-derived growth factor (PDGF) levels in peri-implant crevicular fluid to assess the biological healing response following treatment.
Measured: Baseline to 6 months after surgery
Change in VEGF Levels in Peri-implant Crevicular Fluid
Evaluation of vascular endothelial growth factor (VEGF) levels in peri-implant crevicular fluid as a biomarker of angiogenesis and tissue healing after peri-implantitis surgery.
Measured: Baseline to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start12 Dec 2024
- Primary completion15 Jun 2025
- Study completion15 Oct 2025
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.
- More trials run by Ondokuz Mayıs 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Topçu, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478978
- Sponsor's protocol ID
- OMU-KAEK-2024/21
- Other IDs
- BAP04-B-2024-5660
- Acronym
- CMAPI
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of Collagen Membrane Combined With Allograft Versus Allograft Alone in the Surgical Treatment of Peri-Implantitis
- ClinicalTrials.gov ID
- NCT07478978
- Acronym / sponsor ID
- CMAPI / OMU-KAEK-2024/21
- Keywords
- Peri-implantitis, Collagen membrane, Allograft, PDGF, VEGF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 18 Mar 2026 (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.
Peri-implantitis is an inflammatory condition characterized by inflammation of the peri-implant tissues and progressive loss of supporting bone around dental implants. Surgical treatment is often required in advanced cases to decontaminate implant surfaces and manage peri-implant bone defects. Regenerative approaches frequently include the use of bone graft materials and barrier membranes to promote bone regeneration and improve healing outcomes.
The aim of this randomized clinical trial is to evaluate whether the adjunctive use of a resorbable collagen membrane provides additional benefits when combined with an allograft in the surgical treatment of peri-implantitis. A total of 44 patients diagnosed with peri-implantitis associated with circumferential intrabony defects are randomly allocated into two groups: one treated with allograft combined with a collagen membrane and the other treated with allograft alone.
Clinical parameters including probing depth, bleeding on probing, and suppuration are recorded at baseline and during follow-up. Radiographic marginal bone levels are assessed using standardized periapical radiographs. In addition, peri-implant crevicular fluid samples are collected to measure platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) levels as biochemical indicators of healing. The outcomes of the two treatment approaches are compared to determine whether the use of a collagen membrane provides additional clinical, radiographic, or biochemical benefits in peri-implantitis surgery.
Detailed description
Peri-implantitis is a plaque-associated pathological condition characterized by inflammation of the peri-implant mucosa and progressive loss of supporting bone around dental implants. Due to the structural differences between periodontal and peri-implant tissues, peri-implantitis lesions often show rapid progression and may require surgical intervention in advanced cases. Surgical therapy aims to eliminate the inflammatory lesion, decontaminate the implant surface, and manage peri-implant bone defects.
Regenerative surgical approaches have been proposed to reconstruct peri-implant bone defects and improve treatment outcomes. Bone graft materials are commonly used to provide an osteoconductive scaffold and promote new bone formation. In addition, barrier membranes may be used to stabilize the grafted area and prevent the migration of epithelial and connective tissue cells into the defect site. Resorbable collagen membranes are widely used because of their biocompatibility, resorbability, and ability to support wound stabilization during the healing process.
However, the adjunctive benefit of using a collagen membrane together with a bone graft in the surgical treatment of peri-implantitis remains controversial. Furthermore, limited data are available regarding the biological response associated with these regenerative procedures.
The present randomized clinical trial aims to evaluate the adjunctive effect of a resorbable collagen membrane used in combination with an allograft in the surgical treatment of peri-implantitis. A total of 44 patients diagnosed with peri-implantitis associated with circumferential intrabony defects are randomly assigned to one of two treatment groups: (1) allograft combined with a resorbable collagen membrane (test group) and (2) allograft alone (control group).
Clinical parameters including probing depth, bleeding on probing, and suppuration are recorded at baseline and during follow-up examinations. Radiographic marginal bone levels are evaluated using standardized periapical radiographs. In addition, peri-implant crevicular fluid samples are collected at baseline, 1 month, and 3 months to determine platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) levels using ELISA. These biochemical markers are analyzed to evaluate the biological healing response following surgical treatment.
The outcomes of the two treatment approaches are compared in terms of clinical, radiographic, and biochemical parameters in order to determine whether the use of a collagen membrane provides additional benefit in the reconstructive surgical treatment of peri-implantitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allograft + Collagen Membrane | Experimental | Procedure: Collagen Membrane + AllograftParticipants receive reconstructive surgical treatment for peri-implantitis using a particulate allograft alone without the use of a collagen membrane following implant surface decontamination and defect debridement. |
| Allograft Alone | Active comparator | Procedure: AllograftParticipants receive reconstructive surgical treatment for peri-implantitis using particulate allograft alone following implant surface decontamination and defect debridement. No collagen membrane is applied in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with peri-implantitis characterized by bleeding and/or suppuration on probing and increased probing depth around dental implants.
- Presence of circumferential intrabony peri-implant defects requiring reconstructive surgical treatment.
- Patients aged 18 years or older.
- Presence of functioning dental implants in the oral cavity.
- Patients who are able and willing to attend follow-up visits and provide informed consent.
Key exclusion criteria (6 listed)
- Patients with uncontrolled systemic diseases that could affect wound healing.
- Use of antibiotics or anti-inflammatory drugs within the last 3 months.
- Pregnancy or lactation.
- Heavy smoking habits.
- Poor oral hygiene or lack of compliance with periodontal maintenance therapy.
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 |
|---|---|---|
| Collagen Membrane + AllograftAlso: Bone Allograft, Particulate AllograftReconstructive surgical treatment of peri-implantitis in which peri-implant bone defects are filled with particulate allograft and covered with a resorbable collagen membrane following implant surface decontamination and defect debridement. | Procedure or surgery | Allograft + Collagen Membrane |
| AllograftAlso: Bone AllograftReconstructive surgical treatment of peri-implantitis in which peri-implant bone defects are filled with particulate allograft alone following implant surface decontamination and defect debridement, without the use of a collagen membrane. | Procedure or surgery | Allograft Alone |
Primary outcome
Change in Probing Depth (PD)
Time frame: Baseline to 6 months after surgery
Change in peri-implant probing depth measured with a periodontal probe to evaluate the clinical effectiveness of reconstructive surgical treatment of peri-implantitis using allograft with or without a resorbable collagen membrane.
Change in Bleeding on Probing (BoP)
Time frame: Baseline to 6 months after surgery
Change in bleeding on probing around dental implants used to evaluate peri-implant tissue inflammation following reconstructive surgical treatment.
Change in Suppuration on Probing
Time frame: Baseline to 6 months after surgery
Change in the presence of suppuration around implants as an indicator of infection resolution after surgical treatment of peri-implantitis.
Change in Radiographic Marginal Bone Level
Time frame: Baseline to 6 months after surgery
Radiographic evaluation of marginal bone levels around implants using standardized periapical radiographs to assess bone regeneration after reconstructive surgery.
Change in PDGF Levels in Peri-implant Crevicular Fluid
Time frame: Baseline to 6 months after surgery
Evaluation of platelet-derived growth factor (PDGF) levels in peri-implant crevicular fluid to assess the biological healing response following treatment.
Change in VEGF Levels in Peri-implant Crevicular Fluid
Time frame: Baseline to 6 months after surgery
Evaluation of vascular endothelial growth factor (VEGF) levels in peri-implant crevicular fluid as a biomarker of angiogenesis and tissue healing after peri-implantitis surgery.
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Membrane + Allograft and Allograft in people with Peri-implantitis and Guided Bone Regeneration, run by Ondokuz Mayıs 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: finished, as of the sponsor's last update on 19 Mar 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 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?
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?
Change in Probing Depth (PD) (time frame: Baseline to 6 months after surgery). The study lists 6 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 19 Mar 2026.