Dental Cleaning for Pediatric Obesity

OM
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Overseen ByShaddox
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular dental cleaning can enhance the effectiveness of semaglutide, a medication used to treat children with obesity. Researchers seek to discover whether combining dental cleaning with the medication improves oral health and metabolism more than using the medication alone. Participants will receive either both dental cleaning and oral hygiene tips or just the hygiene tips. The trial seeks children who participated in a previous study on childhood obesity and have a BMI significantly above average for their age and sex. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve treatment options for childhood obesity.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. The trial excludes those using anti-inflammatory medications (except steroids) within a month before joining, and those on medications affecting periodontal treatment, like immunosuppressants or steroids.

What prior data suggests that dental cleaning is safe for children with obesity?

Research shows that dental cleanings are generally safe and well-tolerated for children. Studies on children's oral health emphasize the importance of preventive measures, such as regular dental cleanings, to maintain healthy teeth and gums. These studies have not reported any major problems with standard dental cleaning procedures.

Oral hygiene instruction, which teaches children how to care for their teeth and gums, is safe and typically free of side effects.

In summary, both dental cleanings and oral hygiene instruction are widely used and proven safe for children. These treatments aim to improve dental health without any known serious risks.12345

Why are researchers excited about this trial?

Researchers are excited about the trial exploring dental cleaning and oral hygiene instruction for pediatric obesity because it offers a novel approach that is quite different from typical lifestyle or medication-based interventions. By focusing on oral health, this trial aims to uncover a possible link between improved dental hygiene and weight management in children, which hasn't been extensively studied before. This approach could reveal how maintaining good oral hygiene might influence eating habits and, consequently, weight management, offering a fresh perspective in tackling pediatric obesity.

What evidence suggests that dental cleaning could enhance the effects of semaglutide for pediatric obesity?

Research has shown that dental care, such as teeth cleaning, can significantly improve children's oral health. One study found that these treatments result in cleaner teeth and fewer dental issues. For children with obesity, improved oral health might also contribute to overall health. Although no direct evidence links teeth cleaning to obesity reduction, healthier gums and teeth could lead to better health outcomes. In this trial, one group of participants will receive both dental cleaning and Oral Hygiene Instruction (OHI), while another group will receive only OHI. These findings suggest that including dental cleaning in treatments could enhance health benefits for children already using semaglutide for obesity.26789

Who Is on the Research Team?

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Oelisoa Andriankaja, DDS, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for children and teens with severe obesity (BMI at least 120% of the 95th percentile for their age and sex) who are already part of a related study on heart disease risks.

Inclusion Criteria

* participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389)
I have class 2 or 3 obesity for my age and sex.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone, alongside semaglutide treatment

12 months
Regular visits at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dental Cleaning
  • Oral Hygiene Instruction

Trial Overview

The study compares two groups: one gets both dental cleaning plus oral hygiene instruction, while the other receives only oral hygiene instruction. The goal is to see if adding dental cleaning helps improve both mouth health and metabolic outcomes in kids taking semaglutide.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Dental cleaning and Oral Hygiene Instruction (OHI)Experimental Treatment1 Intervention
Group II: Oral Hygiene Instruction (OHI) onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oelisoa Andriankaja

Lead Sponsor

Citations

MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks ...

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 ...

A Meta-analysis of Oral Health Interventions in Children - PMC

This meta-analysis provides strong evidence that oral health interventions effectively improve multiple aspects of children's oral health. Significant ...

Dental Cleaning for Pediatric Obesity · Info for Participants

The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity.

A national sample of developmentally disabled ...

Among adolescents with DDs and obesity, dental cleanings, fluoride treatments, and dental sealant utilization prevalence were 76%, 48%, and 21%, respectively.

related curricular content and training in dental schools and ...

How- ever, available evidence indicates that the oral health care team has not yet assumed an active role in addressing the pediatric obesity issue (28-32), ...

A Narrative Review on Advancing Pediatric Oral Health - PMC

This review provides a comprehensive analysis of children's dental development, common oral health challenges, and evidence-based preventive strategies.

Obesity and Dental Caries in School Children

There is some evidence that obesity is positively associated with dental caries [9,10,11,12], but there is also some evidence that it is not [7, ...

Addressing Childhood Obesity in the Dental Setting

Research has demonstrated the need for more specific education and training for both dentists and dental hygienists in the area of childhood obesity and ...

Addressing Childhood Overweight and Obesity in the Dental ...

The purposes of this paper were to: review health and dental implications; present guidelines for tracking body mass index (BMI) percentiles in children.