NCT07478653 · Oelisoa Andriankaja
MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease
What this study is about
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 taken by mouth health and metabolic outcomes beyond the effects of semaglutide alone.
View original scientific description
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.
Interventions
PROCEDURE
Dental Cleaning and Oral Hygiene Instruction (OHI)
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
Oral Hygiene Instruction (OHI)
Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
Primary outcome measures
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.
Change in Bacterial Subgingival Biofilm
Time frame: Baseline, 6 months, 12 months
Collected from the same sites as GCF using sterile endodontic paper points.
Change in levels of Interleukin-1 beta (IL-1β)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Tumor Necrosis Factor-alpha
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Interleukin-6 (IL-6)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of C-reactive protein (CRP)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of endocan
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in Oral Microbiome
Time frame: Baseline, 6 months, 12 months
DNA sequencing. Saliva will be collected.
Change in active oral microbiome (RNA sequencing)
Time frame: Baseline, 6 months, 12 months
RNA sequencing. Saliva will be collected.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Lexington, Kentucky
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations