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Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.

NCT07470281 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-11

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment 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 gingival recession reduction and percentage of root coverage 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, 90, and 180 days after treatment.
* To provide different biological samples
* To answer different questionnaires.

Conditions

Interventions

PROCEDURE

Coronally Advance Flap associated with connective tissue graft (CAF+CTG)

A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ

Sponsors & Collaborators

  • Mauro Santamaria

    lead OTHER

Principal Investigators

  • Mauro Santamaria, DDS, MS, PhD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-04-30
Completion
2030-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470281 on ClinicalTrials.gov