Health TrialsbyHealthPanel

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

ConditionsObesityDental Care for Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorOelisoa Andriankaja

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dental Cleaning and Oral Hygiene Instruction (OHI)

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Dental cleaning and Oral Hygiene Instruction (OHI)Experimental treatment 1 intervention
Group B: Oral Hygiene Instruction (OHI) onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in gingival index

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.

Time frame
Baseline, 6 months, 12 months
2

Change in probing depth

Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.

Time frame
Baseline, 6 months, 12 months
3

Change in BOP (Bleeding on probing)

Presence or absence of bleeding upon probing recorded at six sites per tooth.

Time frame
Baseline, 6 months, 12 months
4

Change in Plaque Index

Measured using a plaque score (0-3) at six specific Ramfjord teeth

Time frame
Baseline, 6 months, 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oelisoa Andriankaja

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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