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The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question[s] it aims to answer [is/are]:
if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone.
Participants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.
Parent study NCT06967389
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental cleaning and Oral Hygiene Instruction (OHI) | Experimental |
| |
| Oral Hygiene Instruction (OHI) only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Cleaning and Oral Hygiene Instruction (OHI) | Procedure | Participants receive dental cleaning and oral hygiene instruction (OHI) and oral health assessments at baseline (prior to initiating weight-loss medication), 6 months (±2 weeks), and 12 months (±1 month) post-enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival index | Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation. | Baseline, 6 months, 12 months |
| Change in probing depth | Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe. | Baseline, 6 months, 12 months |
| Change in BOP (Bleeding on probing) | Presence or absence of bleeding upon probing recorded at six sites per tooth. | Baseline, 6 months, 12 months |
| Change in Plaque Index | Measured using a plaque score (0-3) at six specific Ramfjord teeth | Baseline, 6 months, 12 months |
| Change in Clinical Attachment Level (CAL) | Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site. | Baseline, 6 months, 12 months |
| Change in Gingival Margin Position (GM) | Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe. | Baseline, 6 months, 12 months |
| Number of participants with Supragingival and Subgingival Calculus | Recorded as present or absent, generalized or localized when visible or detected upon probing. | Baseline, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oelisoa Mireille Andriankaja, DDS, MS, PhD | Contact | 8595620597 | oelisoa.andriankaja@uky.edu | |
| Shaddox | Contact | oelisoa.andriankaja@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oelisoa Andriankaja, DDS, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| Label | URL |
|---|---|
| Parent Study. | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Oral Hygiene Instruction (OHI) | Behavioral | Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months. |
|
| Change in Gingival Crevicular Fluid (GCF) | Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites. | Baseline, 6 months, 12 months |
| Change in Bacterial Subgingival Biofilm | Collected from the same sites as GCF using sterile endodontic paper points. | Baseline, 6 months, 12 months |
| Change in levels of Interleukin-1 beta (IL-1β) | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of Tumor Necrosis Factor-alpha | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of Interleukin-6 (IL-6) | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of C-reactive protein (CRP) | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1) | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1) | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of endocan | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in levels of Vascular Endothelial Growth Factor A (VEGF-A) | levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame | Baseline, 6 months, 12 months |
| Change in Oral Microbiome | DNA sequencing. Saliva will be collected. | Baseline, 6 months, 12 months |
| Change in active oral microbiome (RNA sequencing) | RNA sequencing. Saliva will be collected. | Baseline, 6 months, 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |