Dental Care for Children, Obesity
Conditions
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.
Detailed description
Parent study NCT06967389
Interventions
BEHAVIORALOral 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.
PROCEDUREDental 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.
Sponsors
Oelisoa Andriankaja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival index | 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 | 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) | Baseline, 6 months, 12 months | Presence or absence of bleeding upon probing recorded at six sites per tooth. |
| Change in Plaque Index | Baseline, 6 months, 12 months | Measured using a plaque score (0-3) at six specific Ramfjord teeth |
| Change in Clinical Attachment Level (CAL) | Baseline, 6 months, 12 months | Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site. |
| Change in Gingival Margin Position (GM) | 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 | 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) | Baseline, 6 months, 12 months | Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites. |
| Change in Bacterial Subgingival Biofilm | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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 | Baseline, 6 months, 12 months | DNA sequencing. Saliva will be collected. |
| Change in active oral microbiome (RNA sequencing) | Baseline, 6 months, 12 months | RNA sequencing. Saliva will be collected. |
Countries
United States
Contacts
CONTACTOelisoa Mireille Andriankaja, DDS, MS, PhD
CONTACTShaddox
PRINCIPAL_INVESTIGATOROelisoa Andriankaja, DDS, PhD
University of Kentucky
Outcome results
None listed