Status:
ENROLLING_BY_INVITATION
Regenerative Treatment of Peri-implantitis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Osteogenics Biomedical
Conditions:
Peri-Implantitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 f...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06153212
Start Date
November 2 2023
End Date
December 1 2026
Last Update
January 23 2025
Active Locations (1)
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1
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109