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NCT Number: NCT06294587

Evaluation of Free Gingival Graft Timing

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location status: Recruiting

Location contact

Hussein Basma, DDS, MS

CONTACT

[email protected]

205-975-2888

Hussein Basma, DDS, MS

PRINCIPAL_INVESTIGATOR

Sarah Startley, DMD

CONTACT

[email protected]

205-975-8711

About this study

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. The primary objective is to assess the influence of the tissue graft timing on the outcomes of the guided bone regeneration. The secondary goal is to compare the complications that may arise following the two procedures before implant placement.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

FGG Before GBR

Procedure

Free Gingival Graft before the guided bone regeneration,

FGG after GBR

Procedure

Free Gingival Graft after the guided bone regeneration,

Primary outcomes

  1. Volumetric outcome assessment

    Time frame: Baseline to 12 months

    The volumetric outcomes of interest will be volume change in mm3 (Vol) and the mean distance between the surface/mean thickness of the reconstructed volume in mm.

  2. Buccal soft tissue profile

    Time frame: Baseline to 12 months

    The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder.

Study contacts

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

Hussein Basma, DDS, MS

CONTACT

[email protected]

205-975-2888

Sarah Startley, DMD

CONTACT

[email protected]

205-975-8711

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2024
Registry last updated
Aug 6, 2025

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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