NCT07478653NARecruiting
MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease
Oelisoa Andriankaja
Start Date
8/31/2026
Completion Date
7/31/2028
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.
Detailed Description
Parent study NCT06967389
Eligibility Criteria
Age Range: 12 years to 17 years
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
Interventions
PROCEDURE
Dental Cleaning and Oral Hygiene Instruction (OHI)
BEHAVIORAL
Oral Hygiene Instruction (OHI)
Conditions
ObesityDental Care for Children
Locations
University of Kentucky
Lexington, Kentucky 40506
United States