Root Coverage Using ADM and Coronally Positioned Tunnel With or Without Enamel Matrix Derivative
Completed · Phase 4
Conditions studied: Recession, Gingival
In brief
24 patients will be treated with a coronally positioned tunnel with AlloDerm RTM with or without the addition of Enamel Matrix Derivative to compare the baseline and 6-month changes in recession defect coverage, clinical attachment levels, amount of keratinized tissue width, and soft tissue thickness.
Key facts
- Study ID
- NCT05565079
- Run by
- University of Louisville
- People needed
- 24
- Starts
- 2022-10-06
- Expected to finish
- 2024-10-30
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Presence of at least one Miller class 1 or 2 soft tissue recession defect >3 mm on a non-molar tooth.
- Healthy patients, at least 18 years of age.
- Patient understands and signs an informed consent approved by the University of Louisville IRB.
You may not qualify if…
- Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, infectious diseases, or psychological problems that may interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergies to any of the materials used in the study, including systemic antibiotics.
- Patients that use tobacco products (smoking, smokeless tobacco, or electronic cigarettes).
- Patients with alcohol abuse problems.
- Patients requiring antibiotic prophylaxis for dental procedures.
- Cemento-enamel unction not identifiable.
- Root surface restorations at the recession site.
- Patients undergoing long-term steroid therapy.
- History of previous root coverage procedure, graft, or guided tissue regeneration involving the recession site.
- Pregnant or lactating patients.
- Patients who fail to maintain oral hygiene levels of at least 80% plaque-free surfaces.
- Patients who fail to complete the informed consent form.
Where it is running
- University of Louisville — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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