Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Free gingival graft.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Gingival Recession, Generalized, Gingival Recession, Localized. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Open and Closed Wounds
Overview
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.
Interventions
- Procedure Free gingival graft
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 measures
- Remaining wound area (RWA) [Time frame: 3 months]
Secondary outcome measures (4)
- Epithelialization - EPT [Time frame: 3 months]
- Insomnia Severity Index Survey [Time frame: Baseline and up to 4 weeks]
- Tissue thickness - TT [Time frame: 3 months]
- Inflammatory markers [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- aged ≥ 18 years;
- non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
- in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
- periodontal stable (BoP ≤25%)(Lang et al. 2003);
- no morphological or pathological conditions in the palatal mucosa.
Exclusion criteria
- patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
- taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Pregnancy/lactation (assessed via self-report);
- current opportunistic oral lesions that mainly colonize the palate region;
- subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
- prisoners;
- signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
- subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- College of Dentistry - University of Kentucky — Lexington
Publications
- Miguel MMV, Mathias-Santamaria IF, Rossato A, Ferraz LFF, Rangel TP, Casarin RCV, Tatakis DN, Santamaria MP. Enamel matrix derivative effects on palatal mucosa wound healing: Randomized clinical trial. J Periodontal Res. 2021 Dec;56(6):1213-1222. doi: 10.1111/jre.12934. Epub 2021 Sep 19. PMID 34541683
- Santamaria MP, Mathias-Santamaria IF, Ferreira Bonafe AC, Gonzalez OA, Kirakodu S, Monteiro MF, Casarin RCV, Shaddox LM, Miguel MMV. Microbiome and Inflammatory Biomarkers Associated With Palatal Wound Healing. J Periodontal Res. 2025 Jul;60(7):664-675. doi: 10.1111/jre.13373. Epub 2025 Jan 13. PMID 39801488
Identifiers
NCT: NCT07500935 · IRB-109004