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Regenerative Treatment of Peri-implantitis | Clinical Trials | Clareo Health

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Regenerative Treatment of Peri-implantitis

Regenerative Treatment of Peri-implantitis: A Comparison of the Reinforced PTFE Mesh (RPM) and the Collagen Membrane in the Submerged Approach: a Randomized Controlled Clinical Trial

NCT06153212•University of Michigan

View on ClinicalTrials.gov

Summary

The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.

Detailed Description

Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial. 32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years
•Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
•Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):
•Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
•Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm
•Implants which have been in function for at least 6 months

Exclusion Criteria

•A clearly mal-positioned dental implant
•Significant interproximal horizontal bone loss (more than 50% of implant fixture length)
•A mobile dental implant
•Presence of uncontrolled or untreated periodontal disease
•More than 2 weeks usage of antibiotics in the past two months
•Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c \> 8)).
•Pregnant subjects or individuals attempting to get pregnant (self-reported)
•Subjects smoking more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
•Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)
•Any other contraindications for undergoing periodontal surgery

Locations (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Key Dates

Start Date

November 2, 2023

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Peri-Implantitis

Interventions

Membrane placement with bone grafting

PROCEDURE

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

NCT07466966

Peri-implantitisPeriodontitis+1 more

View study

RECRUITING

The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors

NCT07004517

Peri-ImplantitisDiagnosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Regenerative Treatment of Peri-implantitis

Inclusion Criteria

Exclusion Criteria

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors

Monitoring of Implant Diseases: Diagnosis and Monitoring with AMMP-8 Test Technology

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Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials

Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis