Ridge AugmentationNCT06294587
Evaluation of Free Gingival Graft Timing
A study testing FGG Before GBR and FGG after GBR in people with Ridge Augmentation and Alveolar Mucosa, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ridge Augmentation, Alveolar Mucosa
- What is being tested?
- FGG Before GBR and FGG after GBR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007
Hussein Basma, DDS, MS, 205-975-2888, basma86@uab.edu
Sarah Startley, DMD, 205-975-8711, ss1971@uab.edu
About this study
Official title: Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ridge Augmentation, Alveolar Mucosa
- Being tested
- FGG Before GBR, FGG after GBR
- Keywords
- Ridge Augmentation, Attached mucosa, Dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGG Before GBRProcedure or surgery
Free Gingival Graft before the guided bone regeneration,
FGG after GBRProcedure or surgery
Free Gingival Graft after the guided bone regeneration,
| Study group | Role | What they receive |
|---|---|---|
| FGG before GBR | Experimental | Free Gingival Graft(FGG) before the guided bone regeneration(GBR) Receives: Procedure: FGG Before GBR |
| FGG after GBR | Experimental | Free Gingival Graft(FGG) after the guided bone regeneration(GBR) Receives: Procedure: FGG after GBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Buccal soft tissue profile
The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start12 Aug 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge AugmentationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Basma, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294587
- Sponsor's protocol ID
- IRB-300012407
- Other IDs
- UAB-SOD
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06294587
- Acronym / sponsor ID
- IRB-300012407
- Conditions
- Ridge Augmentation, Alveolar Mucosa
- Keywords
- Ridge Augmentation, Attached mucosa, Dental implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGG before GBR | Experimental | Procedure: FGG Before GBRFree Gingival Graft(FGG) before the guided bone regeneration(GBR) |
| FGG after GBR | Experimental | Procedure: FGG after GBRFree Gingival Graft(FGG) after the guided bone regeneration(GBR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • At least 18 years old
Key exclusion criteria (12 listed)
- Active infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FGG Before GBRFree Gingival Graft before the guided bone regeneration, | Procedure or surgery | FGG before GBR |
| FGG after GBRFree Gingival Graft after the guided bone regeneration, | Procedure or surgery | FGG after GBR |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FGG Before GBR and FGG after GBR in people with Ridge Augmentation and Alveolar Mucosa, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hussein Basma, DDS, MS (205-975-2888, basma86@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric outcome assessment (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.