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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 โฅ 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 | 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 ร 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. |
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| 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 ร 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free gingival graft | Procedure | 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 ร 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Epithelialization - EPT | Standardized photographs will be taken after a disclosure solution (Disclosing Agent, Dentsply, Charlotte, NC, USA) application in the wound area at 1,2, 4, and 12 weeks postoperatively. The epithelialized area was calculated as the percentage of the original wound area using software (Image J- NIH, Bethesda, Maryland, USA) calibrated with a measuring scale in the palate. |
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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 Pedrine 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 |
|---|---|---|---|
| 34541683 | Background | 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. | |
| 39801488 | Background |
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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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| 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 |
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| 3 months |
| 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 |
| Tissue thickness - TT | An endodontic spreader with a stop rubber will be inserted at the center of the wound area until reaching the bone. The distance between the instrument tip and the rubber stopper will be measured with a digital caliper | 3 months |
| Inflammatory markers | The wound exudate may be collected 1 week after the procedure. Two paper strips (periopaper, Oraflow, Inc.) per wound will be individually placed and left in position for 40-60 s each. Before sampling, the wound will be gently rinsed and dried using water and an air spray. Relative isolation will then be performed immediately. If contamination with blood or saliva occurs, the paper strip will be discarded, and a new sample will be collected. In sequence, both paper strips will be placed into Eppendorf tubes and stored at -80ยบ Celsius for further processing of inflammatory markers by Multiplex assay | 2 weeks |
| 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. |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |