Root Coverage Using ADM and Coronally Positioned Tunnel With or Without Enamel Matrix Derivative

Launched by UNIVERSITY OF LOUISVILLE · Sep 29, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment for gum recession, which is when the gums pull away from the teeth, leaving roots exposed. The study will involve 24 patients who have a specific type of gum recession on their teeth. Participants will receive a procedure called a coronally positioned tunnel, which uses a special material (AlloDerm RTM) to help cover the exposed roots. Some participants will also receive an additional treatment called Enamel Matrix Derivative. The main goal is to see how effective these treatments are in improving gum coverage, attachment levels, and the overall health of the gum tissue over a period of six months.

To be eligible for this study, participants should be at least 18 years old and have a gum recession of more than 3 mm on a non-molar tooth. However, individuals with certain health conditions, such as serious systemic diseases, recent cancer treatments, or those who smoke, will not be able to participate. Participants can expect to receive detailed instructions and care throughout the study, and they will need to maintain good oral hygiene. This trial is currently recruiting, and anyone interested should consult with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.