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RECRUITING Not applicable ClinicalTrials.gov

MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease

Sponsor: Oelisoa Andriankaja • ClinicalTrials.gov ID: NCT07478653

Registry updated: 2026-10-08
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Description

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.

Interventions

  • 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.
  • 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.

Eligibility criteria

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

Conditions

Obesity Dental Care for Children

Locations

  • University of Kentucky — Lexington, Kentucky, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record