Recruiting

Free Gingival Graft vs. Guided Bone Regeneration

Sponsor:

University of Alabama at Birmingham

Code:

NCT06294587

Conditions

Ridge Augmentation

Alveolar Mucosa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FGG Before GBR

FGG after GBR

Study Details

Brief summary:

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.

Conditions

Ridge Augmentation

Alveolar Mucosa

Study ID

NCT06294587

Start date

Aug 12, 2024

Status verified date

Aug, 2026

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • • At least 18 years old

  • No uncontrolled medical conditions or medications that will affect their bone healing.
  • Good oral hygiene is defined as a full-mouth plaque score ≤25%11.
  • Must be able to read and understand the informed consent document.
  • Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth.
  • Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan.
  • The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required.
  • The patient is not pregnant or breastfeeding.

Exclusion Criteria:

  • Active infectious diseases.

  • Liver or kidney dysfunction/failure.
  • Uncontrolled diabetes (HbA1c ≥ 8.5).
  • Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure.
  • Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications).
  • Metabolic bone diseases that affect bone healing such as osteoporosis.
  • Pregnant or lactating women (self-reported).
  • Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (\> 10 cigarettes) who quit \< 10 ago (self-reported).
  • Poor oral hygiene.
  • Vertical loss of bone at the edentulous ridge.
  • History of periodontal disease.
  • The patient is pregnant or breastfeeding

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FGG before GBR

Free Gingival Graft(FGG) before the guided bone regeneration(GBR)

experimental: FGG after GBR

Free Gingival Graft(FGG) after the guided bone regeneration(GBR)

Interventions

FGG Before GBR

Free Gingival Graft before the guided bone regeneration,

FGG after GBR

Free Gingival Graft after the guided bone regeneration,

Primary outcome measure

  • Volumetric outcome assessment [ Time Frame: Baseline to 12 months ]
  • Buccal soft tissue profile [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Hussein Basma, DDS, MS

205-975-2888basma86@uab.edu

Sarah Startley, DMD

205-975-8711ss1971@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

Principal Investigator:

Hussein Basma, DDS, MS

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Ridge Augmentation
  • Attached mucosa
  • Dental implants

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 2026-08-12.