NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingNA

Sponsor: Oelisoa Andriankaja

Conditions: Obesity, Dental Care for Children

Interventions: Dental Cleaning and Oral Hygiene Instruction (OHI), Oral Hygiene Instruction (OHI)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Lexington, Kentucky, United States