Photobiomodulation on Major Salivary Glands in Children With Caries Activity

Not Applicable

Recruiting

• Conditions: Caries,Dental
• Interventions: Device: Photobiomodulation; Device: Photobiomodulation- Sham

• Registration Number: NCT05546528
• Lead Sponsor: University of Nove de Julho

Brief Summary

The purpose of this trial is to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries activity.

Detailed Description

Dental caries represents one of the most prevalent diseases among children around the world. Saliva plays a preponderant role in the process of demineralization- remineralization of the dental surface. Patient salivary characteristics, such as flow rate, pH, and buffering capacity, provide relevant information about patient's risk for developing carious lesions. Photobiomodulation has shown promising results to improve salivary flow rate, as well as buffer capacity in the adult population. The purpose of this trial is to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries activity.

Methods: This protocol details a randomized, double-blind, parallel-group, controlled trial evaluating salivary parameters through photobiomodulation in children. Seventy-eight 6- to 12-year-old participants will be randomly divided in two groups: 1) the photobiomodulation experimental group (G1) (n=39), 2) the photobiomodulationn placebo group (G2) (n=39). Infrared light will be applied in 16 intra and extraoral points and the placebo, respectively. The unstimulated salivary sample will be taken before and immediately after the application once a week, for three consecutive weeks. Salivary samples will be analyzed for flow rate, pH and buffering capacity. The primary outcomes are difference in salivary flow rates between the G1 and the G2. The secondary outcomes are difference in salivary pH and buffering capacity between the G1 and the G2 group.

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Study Start: 2023-01-20
• Primary Completion: 2023-07-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Study Completion: 2023-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
photobiomodulation	Photobiomodulation	photobiomodulation application with the Laser Therapy XT device
photbiomodulation-sham	Photobiomodulation- Sham	photobiomodulation application with the Laser Therapy XT device off

Primary Outcome Measures

Name	Time	Method
Salivary flow	three weeks	Saliva flow rate will be estimated by asking the children to salivate into the plastic cylinders (previously weighed) for 5 minutes. Next, these plastic cylinders (containing the saliva) will be weighed and the flow rate in g/ml will be calculated, which is equivalent to ml/min,

Secondary Outcome Measures

Name	Time	Method
Saliva pH	three weeks	aliva pH will be measured using a previously calibrated digital pH meter

Trial Locations

Locations (1)

Magdalena San-Martín; 🇺🇾 Montevideo, Uruguay