Reconstructive Treatment of Peri-implantitis With Combined Defects

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).

Study Overview

• Status: Recruiting
• Conditions: Peri-implantitis
• Intervention / Treatment: Device: DBMM-C plus Resorbable collagen membrane; Device: DBMM-C

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sila Cagri Isler, PhD; Phone Number: +905069966074; Email: silaisler@gazi.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06490
    • Recruiting
    • Gazi University Faculty of Dentistry
    • Contact: Sila Cagri Isler; Phone Number: +903122034232; Email: silaisler@gazi.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test Group; Reconstructive surgical therapy of combined peri-implantitis defects using a resorbable collagen membrane and DBMM-C.	Device: DBMM-C plus Resorbable collagen membrane; 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.
Active Comparator: Control group; Reconstructive surgical therapy of combined peri-implantitis defects using only DBMM-C.	Device: DBMM-C; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after the surgical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bleeding on probing (BOP) (%)	The percentage of BOP around six sites of the implant	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	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.	12 months after the surgical treatment
Patient morbidity - Postoperative pain	Postoperative pain will be assessed using a visual analogue score	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	At baseline and after 2 weeks and 1 and 12 months following surgical treatment

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General 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.
• Schwarz 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.
• Raabe 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 26, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: peri-implantitis; barrier membrane; Bone defect; Reconstructive therapy
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis
• Other Study ID Numbers: 2024-KAEK-27/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No