Root Coverage Using ADM and Coronally Positioned Tunnel With or Without Enamel Matrix Derivative (NCT05565079) | Clinical Trial Compass
CompletedPhase 4
Root Coverage Using ADM and Coronally Positioned Tunnel With or Without Enamel Matrix Derivative
United States24 participantsStarted 2022-10-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.