What this study is
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.
What's being tested
- Membrane placement with bone grafting
Intervention · PROCEDURE
The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.
Study details
- Official title
- 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
- Sponsor
- University of Michigan
- Conditions
- Peri-Implantitis
- Enrolling
- 32 people
- Starts
- 2023-11-02
- Est. completion
- 2027-12-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Study team
Sponsor
University of Michigan
Study ID HUM00169735
Principal investigator
Muhammad Saleh, BDS, MSD
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.