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NCT Number: NCT04920136

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

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).

Recruiting

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Key information

Conditions

Gingival Recession Gingival Diseases Lack of Keratinized Attached Peri-implant Mucosa Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Thin Gingiva

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Procedure

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 outcomes

  1. Quality of soft tissue regenerated

    Time frame: From baseline to 12 months

    Compare the change in soft tissue quality (attached or keratinized ) between two used soft tissue grafts by superimposing the before and after intraoral scans and the calculating using a software the difference of soft tissue gain between both scans in (mm)

  2. Quantity of soft tissue regenerated (Width of Keratinized Tissue)

    Time frame: From baseline to 12 months

    Using a periodontal probe , the width of keratinized tissue will be measured in (mm) and compared between two grafts used.

Study contacts

Contact information is provided by the study sponsor or research team.

Hussein Basma, DDS, MS

CONTACT

[email protected]

2059344506

Sarah Startley, DMD

CONTACT

[email protected]

2059758711

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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