Root Coverage Using Acellular Dermal Matrix and a Coronally Positioned Tunnel With or Without Biologic Materials
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Louisville
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Recession defect coverage
Study Overview
Brief 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.
Detailed Description
Study Design: 24 patients will be treated: 12 with a coronally positioned tunnel with AlloDerm RTM (control), and 12 patients with a coronally positioned tunnel with Alloderm RTM and enamel matrix derivative (test). Included patients will undergo root coverage using the basic principles of a coronally positioned tunnel as described by Allen (2005). Six exams for measurements will be performed per patient: preoperative, two-week, one-, two-, four-, and six-months postoperatively.
Presurgical Management: Each patient will receive a diagnostic work-up, including standardized radiographs of the selected site and adjacent teeth (periapical and bitewing), clinical photographs, and a full mouth clinical examination. All women of childbearing potential will receive a pregnancy test. Presurgical preparation will include detailed oral hygiene instructions, scaling and root planing under local anesthesia, and occlusal adjustment (if indicated). Baseline data will be collected on the day of surgical treatment.
Clinical Measurements:
Baseline, two-week, one-, two-, four, and six-month data for the test site and adjacent dentition will include the following:
- Miller's recession defect classification: Miller (1985).
- Plaque index: Silness and Loe (1964).
- Gingival index: Loe (1967).
- Bleeding on probing index: Dichotomous scoring.
- Gingival margin levels (Recession): Measured from CEJ to the gingival margin.
- Keratinized tissue width: Measured from the gingival margin to the mucogingival junction.
- Clinical attachment level: Measured from CEJ to the bottom of the clinical periodontal pocket.
- Clinical tooth mobility: Modified Miller's Index, Laster (1975).
- Radiographic examination: Paralleling technique with pre-operative periapical and bitewing radiographs.
- Soft Tissue Thickness: Soft tissue measurements will be taken at three mid-buccal positions.
- Tooth vitality: Tested with electric pulp tester and cold testing.
- Patient models.
- Clinical photographs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The study involves an investigator (surgeon) and an examiner. The examiner measures the clinical parameters before and after surgery and is blinded to the surgical procedure and if the patient receives biologic materials.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix Derivative
12 patients will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm RTM, BioHorizons) and a porcine derived enamel matrix derivative (Emdogain, Straumann).
Intervention: Regenerative tissue matrix and enamel matrix derivative (Biological)
Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix Derivative
12 patients will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm RTM, BioHorizons) and a porcine derived enamel matrix derivative (Emdogain, Straumann).
Intervention: Regenerative tissue matrix (Biological)
Coronally positioned tunnel with AlloDerm RTM
12 patients will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm RTM, BioHorizons).
Intervention: Regenerative tissue matrix (Biological)
Outcomes
Primary Outcomes
Recession defect coverage
Time Frame: 6 months
To compare baseline and 6-month changes in recession defect coverage
Secondary Outcomes
- Soft tissue thickness(6 months)
- Keratinized tissue width(6 months)
- Clinical attachment levels(6 months)
Investigators
Himabindu Dukka
Assistant Professor, DMD
University of Louisville