Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
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: Coronally Advance Flap associated with connective tissue graft (CAF+CTG).
- 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 Closed Wounds
Overview
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.
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
Primary outcome measures
- gingival recession reduction [Time frame: 6 months]
Secondary outcome measures (9)
- Probing depth [Time frame: 6 month]
- Clinical attachment level [Time frame: 6 months]
- PROMIS Adult Sleep Disturbance Survey [Time frame: Baseline and up to 4 weeks]
- Insomnia Severity Index Survey [Time frame: Baseline and up to 4 weeks]
- Change in Dentin hypersensitivity [Time frame: Baseline and up to 6 months]
- Number of analgesics [Time frame: 7 days]
- Discomfort [Time frame: 7 days]
- Root Coverage Esthetic Score [Time frame: 6 months]
- gingival crevicular fluid (GCF) inflammatory markers [Time frame: 6 months]
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
- Treatment
Study locations
United States · 1 center
- College of Dentistry - University of Kentucky — Lexington
Publications
- Meyer MD, Coelho RMI, Rangel-Coelho JP, Costa BC, Teixeira LN, Martinez EF, Casarin RCV, Santamaria MP, Franca FMG, Nociti-Jr FH, Lisboa-Filho PN, Kantovitz KR. Titanium dioxide nanotubes incorporated into conventional glass ionomer cement alter the biological behavior of pre-odontoblastic cells. Colloids Surf B Biointerfaces. 2025 Feb;246:114389. doi: 10.1016/j.colsurfb.2024.114389. Epub 2024 Nov PMID 39591848
- Santamaria MP, Mathias-Santamaria IF, Tavelli L, Barootchi S, Prato GPP. An updated evidence-based recommendation for the treatment of gingival recession associated with non-carious cervical lesions. J Periodontol. 2026 May;97(5):1010-1025. doi: 10.1002/jper.70049. Epub 2026 Jan 7. PMID 41498281
Identifiers
NCT: NCT07470281 · 109004