Regenerative Treatment of Peri-implantitis

NCT06153212 | Enrolling By Invitation

• 1 other identifier: HUM00169735
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

• Probing depth measurements in millimeters

  To compare probing depth measurements using a periodontal probe after peri-implantitis treatment

  About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.

• Bone measurements in millimeters

  Bone measurements obtained from CBCT

  Baseline and 8 months after baseline surgery

Secondary Outcomes (3)

• Clinical attachment levels in millimeters

  8 months after baseline surgery

• Marginal bone levels in millimeters at the implant site

  8 months after baseline surgery

• Volumetric changes of grafted area in cubic millimeters

  8 months after baseline surgery

Study Arms (2)

PTFE Mesh Membrane

EXPERIMENTAL

A reinforced PTFE Mesh membrane will be used to cover the bone graft.

Procedure: Membrane placement with bone grafting

Collagen membrane

ACTIVE COMPARATOR

A collagen membrane will be used to cover the bone graft.

Procedure: Membrane placement with bone grafting

Interventions

Membrane placement with bone grafting PROCEDURE

The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.

Collagen membrane; PTFE Mesh Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Osteogenics Biomedical: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Muhammad Saleh, BDS, MSD

  University of Michigan

  PRINCIPAL INVESTIGATOR

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: Clinical Assistant Professor, Periodontics and Oral Medicine

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 1, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)