Recruiting

Strip Gingival Graft & Acellular Dermal Matrix

Sponsor:

University of Alabama at Birmingham

Code:

NCT04920136

Conditions

Gingival Recession

Lack of Keratinized Attached Peri-implant Mucosa

Thin Gingiva

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

Free Gingival graft

Study Details

Brief 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).

Conditions

Gingival Recession

Lack of Keratinized Attached Peri-implant Mucosa

Thin Gingiva

Study ID

NCT04920136

Start date

Sep 17, 2021

Status verified date

Jun, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 implants or edentulous ridges on either side of the involved site(s)

Exclusion Criteria:

  • Non-English speaking
  • Less than 18 years old
  • Smokers/tobacco users (>10 cigarettes/day)
  • Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • Presence of active periodontal disease
  • Previous soft tissue grafting at the site(s) to be treated

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.

A strip of a free gingival graft is then harvested from the patient's palate. This strip is only 2 to 3 mm wide ,1 to 1.5 mm thick and has an appropriate length to cover the full apical extension of the recipient site. The strip is sutured immediately with 6-0 monocryl sutures. Coronal to the strip, the periosteal bed is covered with ADM, which is already rehydrated in sterile saline for 10 min, trimmed and customized to fit the available space. The ADM is then stabilized on the periosteal bed with the epithelium side facing upward. The ADM is fixed on the recipient bed by periosteal 6-0 monocryl sutures.

active comparator: Free gingival graft.

Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area will be sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.

Interventions

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

A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The flap will be then elevated with a split-thickness flap beyond the mucogingival junction where it is sutured at this apical position using a mattress (5-0, monocryl) suture. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.

Free Gingival graft

Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area was sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.

Primary outcome measure

  • Quality of soft tissue regenerated [ Time Frame: From baseline to 12 months ]
  • Quantity of soft tissue regenerated (Width of Keratinized Tissue) [ Time Frame: From baseline to 12 months ]

Central Contacts and Locations

Central contacts

Hussein Basma, DDS, MS

2059344506basma86@uab.edu

Sarah Startley, DMD

2059758711ss1971@uab.edu

Locations

Unversity of Alabama at Birmingham, School of Dentistry

Recruiting

Birmingham, Alabama, United States, 35294-0007

Contacts

Hussein Basma, DDS, MS

205-975-2888basma86@uab.edu

Sarah Startley, DMD

205-975-8711ss1971@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 22, 2026

Last verified

Jun, 2026

Keywords

  • Attached mucosa
  • Keratinized tissue
  • Dental implants
  • Connective tissue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-22.