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

NCT07478653 | Not Yet Recruiting

• 1 other identifier: 108598
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Dental Care for Children

Outcome Measures

Primary Outcomes (19)

• 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.

  Baseline, 6 months, 12 months

• Change in probing depth

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

  Baseline, 6 months, 12 months

• Change in BOP (Bleeding on probing)

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

  Baseline, 6 months, 12 months

• Change in Plaque Index

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

  Baseline, 6 months, 12 months

• Change in Clinical Attachment Level (CAL)

  Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.

  Baseline, 6 months, 12 months

• Change in Gingival Margin Position (GM)

  Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.

  Baseline, 6 months, 12 months

• Number of participants with Supragingival and Subgingival Calculus

  Recorded as present or absent, generalized or localized when visible or detected upon probing.

  Baseline, 6 months, 12 months

• Change in Gingival Crevicular Fluid (GCF)

  Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.

  Baseline, 6 months, 12 months

• Change in Bacterial Subgingival Biofilm

  Collected from the same sites as GCF using sterile endodontic paper points.

  Baseline, 6 months, 12 months

• Change in levels of Interleukin-1 beta (IL-1β)

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of Tumor Necrosis Factor-alpha

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of Interleukin-6 (IL-6)

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of C-reactive protein (CRP)

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of endocan

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)

  levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  Baseline, 6 months, 12 months

• Change in Oral Microbiome

  DNA sequencing. Saliva will be collected.

  Baseline, 6 months, 12 months

• Change in active oral microbiome (RNA sequencing)

  RNA sequencing. Saliva will be collected.

  Baseline, 6 months, 12 months

Study Arms (2)

Dental cleaning and Oral Hygiene Instruction (OHI)

EXPERIMENTAL

Procedure: Dental Cleaning and Oral Hygiene Instruction (OHI)

Oral Hygiene Instruction (OHI) only

ACTIVE COMPARATOR

Behavioral: Oral Hygiene Instruction (OHI)

Interventions

Dental Cleaning and Oral Hygiene Instruction (OHI) 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.

Dental cleaning and Oral Hygiene Instruction (OHI)

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.

Oral Hygiene Instruction (OHI) only

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oelisoa Andriankaja: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Links

• Parent Study.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oelisoa Andriankaja, DDS, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oelisoa Mireille Andriankaja, DDS, MS, PhD

CONTACT

8595620597; oelisoa.andriankaja@uky.edu

Shaddox

CONTACT

oelisoa.andriankaja@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)