Not Yet RecruitingNot Applicable

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

United States50 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in gingival index

Timeframe: Baseline, 6 months, 12 months

Change in probing depth

Timeframe: Baseline, 6 months, 12 months

Change in BOP (Bleeding on probing)

Timeframe: Baseline, 6 months, 12 months

Change in Plaque Index

Timeframe: Baseline, 6 months, 12 months

Change in Clinical Attachment Level (CAL)

Timeframe: Baseline, 6 months, 12 months

Change in Gingival Margin Position (GM)

Timeframe: Baseline, 6 months, 12 months

Number of participants with Supragingival and Subgingival Calculus

Timeframe: Baseline, 6 months, 12 months

Change in Gingival Crevicular Fluid (GCF)

Timeframe: Baseline, 6 months, 12 months

Trial details

NCT IDNCT07478653

SponsorOelisoa Andriankaja

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Oelisoa Mireille Andriankaja, DDS, MS, PhD

8595620597 oelisoa.andriankaja@uky.edu

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in gingival index

Timeframe: Baseline, 6 months, 12 months

Change in probing depth

Timeframe: Baseline, 6 months, 12 months

Change in BOP (Bleeding on probing)

Timeframe: Baseline, 6 months, 12 months

Change in Plaque Index

Timeframe: Baseline, 6 months, 12 months

Change in Clinical Attachment Level (CAL)

Timeframe: Baseline, 6 months, 12 months

Change in Gingival Margin Position (GM)

Timeframe: Baseline, 6 months, 12 months

Number of participants with Supragingival and Subgingival Calculus

Timeframe: Baseline, 6 months, 12 months

Change in Gingival Crevicular Fluid (GCF)

Timeframe: Baseline, 6 months, 12 months