MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease
Registered N/A interventional trial (not yet recruiting). 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.
Registered clinical trial record on ClinicalTrials.gov (NCT07478653). This describes a planned, ongoing, or completed study โ it is NOT peer-reviewed results. Status: not yet recruiting. Study type: interventional. Phase: N/A. Sponsor: Oelisoa Andriankaja. Conditions: Obesity, Dental Care for Children. Interventions: Dental Cleaning and Oral Hygiene Instruction (OHI), Oral Hygiene Instruction (OHI). Summary: 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 Primary outcome measures: Change in gingival index; Change in probing depth; Change in BOP (Bleeding on probing); Change in Plaque Index; Change in Clinical Attachment Level (CAL); Change in Gingival Margin Position (GM); Number of participants with Supragingival and Subgingival Calculus; Change in Gingival Crevicular Fluid (GCF); Change in Bacterial Subgingival Biofilm; Change in levels of Interleukin-1 beta (IL-1ฮฒ); Change in levels of Tumor Necrosis Factor-alpha; Change in levels of Interleukin-6 (IL-6); Change in levels of C-reactive protein (CRP); Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1); Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1); Change in levels of endocan; Change in levels of Vascular Endothelial Growth Factor A (VEGF-A); Change in Oral Microbiome; Change in active oral microbiome (RNA sequencing). Eligibility: Inclusion Criteria: * participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389) * Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex) Exclusion Criteria: * Same exclusion as parent study. * Planning to receive or complete dental services during the 12-month course of the study * Ongoing orthodontic treatment * Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment * Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids) * Local or systemic antibiotic use within 15 days prior to enrollment or for \>10 days within the past 3 months * History of bleeding disorders * Professional dental prophylaxis or non-surgical periodontal therapy within the past 6 months
This is a registered clinical-trial record from ClinicalTrials.gov โ a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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