Photobiomodulation on Major Salivary Glands in Children With Caries Activity

Photobiomodulation Efficacy of Major Salivary Glands in Children With Caries Activity: Study Protocol for Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Device: Photobiomodulation; Device: Photobiomodulation- Sham

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lara J Motta, PhD; Phone Number: 11998829511; Email: larajmotta@terra.com.br
• Study Contact Backup: Name: Magdalena San-Martín, MD; Phone Number: 11998829511; Email: msanmartin@ucu.edu.uy

Study Locations

• Uruguay
  • Montevideo, Uruguay
    • Recruiting
    • Magdalena San-Martín
    • Contact: Magdalena San-Martín, MD; Phone Number: 11998829511; Email: msanmartin@ucu.edu.uy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: photobiomodulation; photobiomodulation application with the Laser Therapy XT device	Device: Photobiomodulation; G1 will receive the photobiomodulation application with the Laser Therapy XT device, (DMC, São Paulo, Brazil). The laser will be applied for 60 seconds per point, in 2 extraoral points and 2 intraoral points in the region of the parotid glands bilaterally, as well as 1 extraoral point for the submandibular and sublingual glands (totaling 16 points).
Sham Comparator: photbiomodulation-sham; photobiomodulation application with the Laser Therapy XT device off	Device: Photobiomodulation- Sham; G2 will receive the photobiomodulation application with the Laser Therapy XT device off. The laser off will be applied for 60 seconds per point, in 2 extraoral points and 2 intraoral points in the region of the parotid glands bilaterally, as well as 1 extraoral point for the submandibular and sublingual glands (totaling 16 points).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary flow	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,	three weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva pH	aliva pH will be measured using a previously calibrated digital pH meter	three weeks

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Estimated): November 20, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: photobiomodulation; dental caries; salivary flow
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PMBSalivaCaries

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No