NCT06294587

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

February 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 12, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

February 28, 2024

Last Update Submit

August 4, 2025

Conditions

Ridge AugmentationAlveolar Mucosa

Keywords

Ridge AugmentationAttached mucosaDental implants

Outcome Measures

Primary Outcomes (2)

  • Volumetric outcome assessment

    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.

    Baseline to 12 months

  • Buccal soft tissue profile

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

    Baseline to 12 months

Study Arms (2)

FGG before GBR

EXPERIMENTAL

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

Procedure: FGG Before GBR

FGG after GBR

EXPERIMENTAL

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

Procedure: FGG after GBR

Interventions

FGG Before GBRPROCEDURE

Free Gingival Graft before the guided bone regeneration,

FGG before GBR
FGG after GBRPROCEDURE

Free Gingival Graft after the guided bone regeneration,

FGG after GBR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

RECRUITING

Central Study Contacts

Hussein Basma, DDS, MS

CONTACT

205-975-2888basma86@uab.edu

Sarah Startley, DMD

CONTACT

205-975-8711ss1971@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 5, 2024

Study Start

August 12, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2027

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations

US(1)