Diabetes Mellitus, Gingival Recession, Generalized, Gingival Recession, Localized
Conditions
Keywords
gingival recession, Diabetes, wound healing
Brief 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.
Interventions
PROCEDURECoronally 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
Mauro Santamaria
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gingival recession reduction | 6 months | The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | 6 month | measured in millimeters using a periodontal probe at the mid-buccal aspect |
| Clinical attachment level | 6 months | measured as probing depth + gingival recession |
| PROMIS Adult Sleep Disturbance Survey | Baseline and up to 4 weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey has each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. |
| Insomnia Severity Index Survey | Baseline and up to 4 weeks | The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia. |
| Change in Dentin hypersensitivity | Baseline and up to 6 months | The participants may be asked about the dentin hypersensitivity in the gingival recession site after a 3-second air blast and self-report esthetic perceptions before the surgery and 3 and 6 months after the surgical protocol. |
| Number of analgesics | 7 days | Number of analgesics taken on the current day for 7 days. |
| Discomfort | 7 days | Participants will be asked to report the discomfort level using a visual analog scale for 7 days after the surgery. Scale ranges from 0 to 10 with a higher score equating to increased discomfort. |
| Root Coverage Esthetic Score | 6 months | The aesthetics of the site will be assessed using the Root Coverage Esthetic - RES Score visually with score (0 "minimum" - 10 "maximum"). A higher score equates to a better esthetic outcome. |
| gingival crevicular fluid (GCF) inflammatory markers | 6 months | The gingival crevicular fluid (GCF) may be collected from the Gingival Recession defect sites before the surgery (visit 1), and 1-,2-, 4-, 12-, 24-weeks after the procedure. Two paper strips (periopaper, Oraflow, Inc.) will be inserted gently into the sulcus for 30 seconds. Before sampling, the area will be gently rinsed and dried using water and an air spray. |
Countries
United States
Contacts
CONTACTDawn G Dawson
PRINCIPAL_INVESTIGATORMauro Santamaria, DDS, MS, PhD
University of Kentucky
Outcome results
None listed