Status
Not yet recruiting
Phase
Not applicable
Enrollment
50
Locations
1
Results
Not posted
Publications
0
Study 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
Interventions
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.
BEHAVIORAL
Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
Timeline
First posted
Mar 17, 2026
Study start
Sep 1, 2026
Primary completion
Jul 31, 2028
Study completion
Jul 31, 2028
Results posted
Not reported
Registry updated
Jul 31, 2026
Outcomes
Change in gingival index
Time frame · Baseline, 6 months, 12 months
Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation.
Change in probing depth
Time frame · Baseline, 6 months, 12 months
Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Change in BOP (Bleeding on probing)
Time frame · Baseline, 6 months, 12 months
Presence or absence of bleeding upon probing recorded at six sites per tooth.
Change in Plaque Index
Time frame · Baseline, 6 months, 12 months
Measured using a plaque score (0-3) at six specific Ramfjord teeth
Change in Clinical Attachment Level (CAL)
Time frame · Baseline, 6 months, 12 months
Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.
Change in Gingival Margin Position (GM)
Time frame · Baseline, 6 months, 12 months
Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Number of participants with Supragingival and Subgingival Calculus
Time frame · Baseline, 6 months, 12 months
Recorded as present or absent, generalized or localized when visible or detected upon probing.
Change in Gingival Crevicular Fluid (GCF)
Time frame · Baseline, 6 months, 12 months
Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.
Not reported in the indexed record.
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Kentucky
Lexington, Kentucky, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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