Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix

Last updated: November 26, 2024
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)

Free Gingival graft

Clinical Study ID

NCT04920136
IRB-300006910
UAB-Perio
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • English speaking

  • At least 18 years old

  • Able to read and understand informed consent document

  • Patients with teeth/implants lacking keratinized tissue.

  • Must be a patient of the UAB Dental School

  • Presence of periodontally healthy, non-carious neighboring teeth, healthy implantsor edentulous ridges on either side of the involved site(s)

Exclusion

Exclusion Criteria:

  • Non-English speaking

  • Less than 18 years old

  • Smokers/tobacco users (>10 cigarettes/day)

  • Patients with systemic pathologies or conditions contraindicating oral surgicalprocedures or adversely affecting wound healing

  • Presence of active periodontal disease

  • Previous soft tissue grafting at the site(s) to be treated

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
Phase:
Study Start date:
September 17, 2021
Estimated Completion Date:
June 30, 2026

Study Description

This investigation is a randomized controlled trial of two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM). To evaluate to determine if either grafting technique (FGG vs SGG+ADM) demonstrates superiority in clinical (amount of KT increase, tissue thickness increase, and practitioner-assessed esthetics) and patient-centered outcomes (pain, swelling, change in daily activities, and patient-assessed esthetics) in a controlled study.

Connect with a study center

  • Unversity of Alabama at Birmingham, School of Dentistry

    Birmingham, Alabama 35294-0007
    United States

    Active - Recruiting

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