Recruiting

Palatal Healing

Sponsor:

Mauro Santamaria

Code:

NCT07500935

Conditions

Diabetes Mellitus

Gingival Recession, Generalized

Gingival Recession, Localized

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Free gingival graft

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus

Gingival Recession, Generalized

Gingival Recession, Localized

Study ID

NCT07500935

Start date

Sep 9, 2026

Status verified date

Oct, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Dawn G Dawson

8593235409dawn.dawson@uky.edu

Locations

College of Dentistry - University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Mauro Pedrine Santamaria, DDS, Ms, PhD

859 323 6297maurosantamaria@uky.edu

Dawn Dawson

859 323-5409dawn.dawson@uky.edu

More Information

Sponsor

Mauro Santamaria

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • gingival recession
  • diabetes
  • wound healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Mauro Santamaria on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.