NCT07478978

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 13, 2026

Last Update Submit

March 17, 2026

Conditions

Peri-implantitisGuided Bone RegenerationBiochemical Markers

Keywords

Peri-implantitisCollagen membraneAllograftPDGFVEGF

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Baseline to 6 months after surgery

Study Arms (2)

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.

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.

Procedure: Allograft

Interventions

Collagen Membrane + AllograftPROCEDURE

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.

Also known as: Bone Allograft, Particulate Allograft
Allograft + Collagen Membrane
AllograftPROCEDURE

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.

Also known as: Bone Allograft
Allograft Alone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University Faculty of Dentistry

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Periodontist

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 18, 2026

Study Start

December 12, 2024

Primary Completion

June 15, 2025

Study Completion

October 15, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)