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

NCT05565079 | Completed Phase 4 FDA Drug

• 1 other identifier: 22.0637
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Recession, Gingival

Keywords

esthetic surgery; allograft; biologic materials; acellular dermis

Outcome Measures

Primary Outcomes (1)

• Recession defect coverage

  To compare baseline and 6-month changes in recession defect coverage

  6 months

Secondary Outcomes (3)

• Clinical attachment levels

  6 months

• Keratinized tissue width

  6 months

• Soft tissue thickness

  6 months

Study Arms (2)

Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix Derivative

EXPERIMENTAL

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).

Biological: Regenerative tissue matrix and enamel matrix derivative; Biological: Regenerative tissue matrix

Coronally positioned tunnel with AlloDerm RTM

ACTIVE COMPARATOR

12 patients will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm RTM, BioHorizons).

Biological: Regenerative tissue matrix

Interventions

Regenerative tissue matrix and enamel matrix derivative BIOLOGICAL

Subjects in this group will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm, RTM) and a porcine-derived enamel matrix derivative (Emdogain).

Also known as: Emdogain, Straumann

Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix Derivative

Regenerative tissue matrix BIOLOGICAL

Subjects in both groups will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm, RTM).

Also known as: AlloDerm RTM, BioHorizons

Coronally positioned tunnel with AlloDerm RTM; Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix Derivative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (3)

• Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.

  PMID: 19968743 RESULT

• Vincent-Bugnas S, Charbit Y, Lamure J, Mahler P, Dard MM. Modified Tunnel Technique Combined with Enamel Matrix Derivative: A Minimally Invasive Treatment for Single or Multiple Class I Recession Defects. J Esthet Restor Dent. 2015 May-Jun;27(3):145-54. doi: 10.1111/jerd.12170.

  PMID: 26094684 RESULT

• Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.

  PMID: 19254123 RESULT

MeSH Terms

Conditions

Gingival Recession

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Bindu Dukka, BDS, MSD, MPH

  Director, Graduate Periodontics, University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, DMD

Model Details: 24 patients will be recruited and randomly grouped as control or test treatment for root coverage using a coronally positioned flap and alloderm with (test) or without (control) enamel matrix derivative.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: October 6, 2022
• Primary Completion: October 7, 2024
• Study Completion: October 30, 2024
• Last Updated: February 10, 2026

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)