Evaluation of Free Gingival Graft Timing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FGG Before GBR
Procedure/SurgeryFree Gingival Graft before the guided bone regeneration,
FGG after GBR
Procedure/SurgeryFree Gingival Graft after the guided bone regeneration,
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: FGG before GBRExperimental treatment 1 intervention
Group B: FGG after GBRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 12 months2
Buccal soft tissue profile
The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder.
Time frame
Baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov