Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
32 participants
INTERVENTIONAL
2023-11-02
2026-12-01
Brief Summary
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Detailed Description
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32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PTFE Mesh Membrane
A reinforced PTFE Mesh membrane will be used to cover the bone graft.
Membrane placement with bone grafting
The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.
Collagen membrane
A collagen membrane will be used to cover the bone graft.
Membrane placement with bone grafting
The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.
Interventions
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Membrane placement with bone grafting
The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Osteogenics Biomedical
INDUSTRY
Responsible Party
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Muhammad Saleh
Clinical Assistant Professor, Periodontics and Oral Medicine
Principal Investigators
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Muhammad Saleh, BDS, MSD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00169735
Identifier Type: -
Identifier Source: org_study_id
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