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

ConditionsDiabetes MellitusGingival Recession, GeneralizedGingival Recession, Localized
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMauro Santamaria

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Free gingival graft

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diabetes groupExperimental treatment 1 intervention
Group B: Non-diabetes groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Remaining wound area (RWA)

The RWA will be measured in square millimeters using software (Image J- NIH, Bethesda, Maryland, USA) at baseline (trans-operative) and 1, 2, 4, and 12 weeks after the surgery

Time frame
3 months

Secondary outcomes

1

Epithelialization - EPT

Standardized photographs will be taken after a disclosure solution (Disclosing Agent, Dentsply, Charlotte, NC, USA) application in the wound area at 1,2, 4, and 12 weeks postoperatively. The epithelialized area was calculated as the percentage of the original wound area using software (Image J- NIH, Bethesda, Maryland, USA) calibrated with a measuring scale in the palate.

Time frame
3 months
2

Insomnia Severity Index Survey

The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia.

Time frame
Baseline and up to 4 weeks
3

Tissue thickness - TT

An endodontic spreader with a stop rubber will be inserted at the center of the wound area until reaching the bone. The distance between the instrument tip and the rubber stopper will be measured with a digital caliper

Time frame
3 months
4

Inflammatory markers

The wound exudate may be collected 1 week after the procedure. Two paper strips (periopaper, Oraflow, Inc.) per wound will be individually placed and left in position for 40-60 s each. Before sampling, the wound will be gently rinsed and dried using water and an air spray. Relative isolation will then be performed immediately. If contamination with blood or saliva occurs, the paper strip will be discarded, and a new sample will be collected. In sequence, both paper strips will be placed into Eppendorf tubes and stored at -80º Celsius for further processing of inflammatory markers by Multiplex assay

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mauro Santamaria

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: