Treatment for gum recession using tissue grafts and enamel matrix

Root Coverage Using Acellular Dermal Matrix and a Coronally Positioned Tunnel With or Without Biologic Materials

This study is testing if using tissue grafts alone or with an extra enamel treatment can help people with gum recession get better results after surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Louisville (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Louisville, Kentucky)
• Trial ID: NCT05565079 on ClinicalTrials.gov

What this trial studies

This clinical trial involves 24 patients with gum recession who will receive treatment using a coronally positioned tunnel technique with AlloDerm RTM, either with or without the addition of Enamel Matrix Derivative. The study aims to compare the effectiveness of these two approaches by measuring changes in recession defect coverage, clinical attachment levels, keratinized tissue width, and soft tissue thickness over a six-month period. Patients will undergo a series of clinical examinations at baseline and at various intervals post-surgery to assess the outcomes of the treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 and older with at least one Miller class 1 or 2 soft tissue recession defect greater than 3 mm on a non-molar tooth.

Not a fit: Patients with systemic diseases affecting the periodontium, recent head and neck radiation or chemotherapy, or those with known allergies to the materials used will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve gum health and aesthetics for patients suffering from gum recession.

How similar studies have performed: Previous studies have shown promising results with similar approaches to treating gum recession, indicating potential for success in this trial.

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.

Where this trial is running

Louisville, Kentucky

• University of Louisville — Louisville, Kentucky, United States (RECRUITING)

Study contacts

• Principal investigator: Bindu Dukka, BDS, MSD, MPH — Director, Graduate Periodontics, University of Louisville
• Study coordinator: Bindu Dukka, BDS, MSD, MPH

Conditions: Recession, Gingival, esthetic surgery, allograft, biologic materials, acellular dermis