Evaluation of Free Gingival Graft Timing | NCT06294587

Studies
Evaluation of Free Gingival Graft Timing

NCT06294587

Sponsor

University of Alabama at Birmingham

Status

Recruiting

Last Update Posted

Aug 6, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Ridge Augmentation
Alveolar Mucosa

Interventions

FGG Before GBR
FGG after GBR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UAB-SOD	Other Identifier	University of Alabama at Birmingham

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 12, 2024Actual

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Aug 30, 2027Estimated

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Feb 28, 2024

First Posted Date

Mar 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2025

Last Update Posted Date

Aug 6, 2025Actual

Description Module

Brief Summary

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FGG Before GBR	Procedure	Free Gingival Graft before the guided bone regeneration,	FGG before GBR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Hussein Basma, DDS, MS	Contact	205-975-2888		basma86@uab.edu
Sarah Startley, DMD	Contact	205-975-8711		ss1971@uab.edu