Using light therapy to improve saliva in children with dental caries
Photobiomodulation Efficacy of Major Salivary Glands in Children With Caries Activity: Study Protocol for Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial
NA · University of Nove de Julho · NCT05546528
This study is testing if light therapy can help improve saliva production in children aged 6 to 12 who have dental cavities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Nove de Julho (other) |
| Locations | 1 site (Montevideo) |
| Trial ID | NCT05546528 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of photobiomodulation, a light therapy technique, on the salivary glands of children aged 6 to 12 with active dental caries. The study involves a randomized, double-blind, parallel-group design with 78 participants divided into two groups: one receiving the actual treatment and the other receiving a placebo. Salivary samples will be collected before and after treatment to assess changes in salivary flow rate, pH, and buffering capacity over three weeks. The goal is to determine if this therapy can enhance salivary parameters that help combat dental caries.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 6 to 12 with at least one active dental caries lesion.
Not a fit: Patients with severe dental issues, fixed dental appliances, or conditions affecting saliva production may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve saliva production and quality in children, potentially reducing the risk of dental caries.
How similar studies have performed: Previous studies have shown promising results for photobiomodulation in adults, but this application in children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
nclusion criteria * Individuals of both sexes, between 6 and 12 years old with mixed dentition. * Participants diagnosed with the presence of at least one active caries lesion * Good general health, without systemic or local diseases that affect salivary secretions. Exclusion criteria * Participants with severe active cavitated lesions with pulpal symptoms. * Plans of the family nucleus to move for the duration of the study. * Patients with a diagnosis of hyposalivation or xerostomia * Presence of fixed appliances. * Physical disability that interferes with oral or intellectual hygiene to answer the questionnaire.
Where this trial is running
Montevideo
- Magdalena San-Martín — Montevideo, Uruguay (RECRUITING)
Study contacts
- Study coordinator: Lara J Motta, PhD
- Email: larajmotta@terra.com.br
- Phone: 11998829511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Caries,Dental, dental caries, photobiomodulation, salivary flow