NCT07500935

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:

  • 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
45mo left

Started Jun 2026

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Apr 2030

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

March 24, 2026

Last Update Submit

April 29, 2026

Conditions

Diabetes MellitusGingival Recession, GeneralizedGingival Recession, Localized

Keywords

gingival recessiondiabeteswound healing

Outcome Measures

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

    3 months

Secondary Outcomes (4)

  • Epithelialization - EPT

    3 months

  • Insomnia Severity Index Survey

    Baseline and up to 4 weeks

  • Tissue thickness - TT

    3 months

  • Inflammatory markers

    2 weeks

Study Arms (2)

Diabetes group

EXPERIMENTAL

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.

Procedure: Free gingival graft

Non-diabetes group

ACTIVE COMPARATOR

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.

Procedure: Free gingival graft

Interventions

Free gingival graftPROCEDURE

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.

Diabetes groupNon-diabetes group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry - University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (2)

  • 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: 34541683BACKGROUND

  • 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: 39801488BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusGingival Recession

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mauro Pedrine Santamaria, DDS, Ms, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn G Dawson

CONTACT

8593235409dawn.dawson@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the results reported in this study, including demographic variables, baseline characteristics, clinical measurements, outcome variables, and relevant covariates. may be made available upon a reasonable request.

Shared Documents
STUDY PROTOCOL

Locations

US(1)