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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:
Participants will be asked:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes group | Experimental |
| |
| Non-diabetes group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronally Advance Flap associated with connective tissue graft (CAF+CTG) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| gingival recession reduction | The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth | measured in millimeters using a periodontal probe at the mid-buccal aspect | 6 month |
| Clinical attachment level | measured as probing depth + gingival recession |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawn G Dawson | Contact | 8593235409 | dawn.dawson@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mauro Santamaria, DDS, MS, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry - University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39591848 | Background | 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 20. | |
| 41498281 |
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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.
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|
| 6 months |
| PROMIS Adult Sleep Disturbance Survey | 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. | Baseline and up to 4 weeks |
| Insomnia Severity Index Survey | The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia. | Baseline and up to 4 weeks |
| Change in Dentin hypersensitivity | 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. | Baseline and up to 6 months |
| Number of analgesics | Number of analgesics taken on the current day for 7 days. | 7 days |
| Discomfort | 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. | 7 days |
| Root Coverage Esthetic Score | 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. | 6 months |
| gingival crevicular fluid (GCF) inflammatory markers | 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. | 6 months |
| Background |
| 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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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