Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Mauro Santamaria
Study ID
NCT07500935
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus
  • Gingival Recession, Generalized
  • Gingival Recession, Localized

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Free gingival graft — PROCEDURE
    Volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.

Study Details

The goal of this clinical trial is to evaluate local and systemic factors involved in palatal mucosal healing after Free Gingival Graft harvest in diabetic patients and to compare them with those in non-diabetic patients. Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are: 1. If the palatal wound healing (area of the wound) and percentage of wound epithelialization are different in diabetics compared to non-diabetics. 2. If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome. Participants will be asked: * Receive the procedure to treat their gingival recession defects * To attend follow-up visits at 7, 14, 30, and 90 days after treatment. * To provide different biological samples * To answer different questionnaires.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Diabetes group
    Diabetic volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.
  • Active Comparator: Non-diabetes group
    Non-diabetic volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.

Primary Outcome Measure

Remaining wound area (RWA) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
College of Dentistry - University of KentuckyLexingtonKentucky40536
Mauro Pedrine Santamaria, DDS, Ms, PhD
[email protected]
859 323 6297
Dawn Dawson
[email protected]
859 323-5409

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By research site
College of Dentistry - University of Kentucky· Lexington, KY

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