Reconstructive Treatment of Peri-implantitis With Combined Defects

NCT06957652 | Recruiting DMC

• 1 other identifier: 2024-KAEK-27/04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Peri-implantitis

Keywords

Reconstructive therapy; peri-implantitis; Bone defect; barrier membrane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of bleeding on probing (BOP) (%)

  12 months after the surgical treatment

• Probing pocket depth (PPD)

  12 months after the surgical treatment

• Change in radiographic vertical defect depth

  12 months after the surgical treatment

• Patient morbidity - Postoperative pain

  At baseline and after 2 weeks and 1 and 12 months following surgical treatment

• Patient-reported satisfaction with the overall treatment

  At baseline and after 2 weeks and 1 and 12 months following surgical treatment

Study Arms (2)

Test Group

ACTIVE COMPARATOR

Reconstructive surgical therapy of combined peri-implantitis defects using a resorbable collagen membrane and DBMM-C.

Device: DBMM-C plus Resorbable collagen membrane

Control group

ACTIVE COMPARATOR

Reconstructive surgical therapy of combined peri-implantitis defects using only DBMM-C.

Device: DBMM-C

Interventions

DBMM-C plus Resorbable collagen membrane DEVICE

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.

Test Group

DBMM-C DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, Turkey, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 36802084 BACKGROUND

• 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.

  PMID: 36852537 BACKGROUND

• 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.

  PMID: 39815673 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Sila Cagri Isler, PhD

CONTACT

+905069966074; silaisler@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

TU (1)