Evaluation of Free Gingival Graft Timing

NCT ID: NCT06294587

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2027-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ridge Augmentation Alveolar Mucosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FGG before GBR

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

Group Type EXPERIMENTAL

FGG Before GBR

Intervention Type PROCEDURE

Free Gingival Graft before the guided bone regeneration,

FGG after GBR

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

Group Type EXPERIMENTAL

FGG after GBR

Intervention Type PROCEDURE

Free Gingival Graft after the guided bone regeneration,

Interventions

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FGG Before GBR

Free Gingival Graft before the guided bone regeneration,

Intervention Type PROCEDURE

FGG after GBR

Free Gingival Graft after the guided bone regeneration,

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Hussein Basma

Clinical Assistant Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hussein Basma, DDS, MS

Role: CONTACT

205-975-2888

Sarah Startley, DMD

Role: CONTACT

205-975-8711

Facility Contacts

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Hussein Basma, DDS, MS

Role: primary

205-975-2888

Sarah Startley, DMD

Role: backup

205-975-8711

Other Identifiers

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UAB-SOD

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300012407

Identifier Type: -

Identifier Source: org_study_id

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