Photobiomodulation on Major Salivary Glands in Children With Caries Activity

NCT05546528 | Unknown

• 1 other identifier: PMBSalivaCaries
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries,Dental

Keywords

dental caries; photobiomodulation; salivary flow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Saliva pH

  three weeks

Study Arms (2)

photobiomodulation

EXPERIMENTAL

photobiomodulation application with the Laser Therapy XT device

Device: Photobiomodulation

photbiomodulation-sham

SHAM COMPARATOR

photobiomodulation application with the Laser Therapy XT device off

Device: Photobiomodulation- Sham

Interventions

Photobiomodulation DEVICE

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).

photobiomodulation

Photobiomodulation- Sham DEVICE

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).

photbiomodulation-sham

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Magdalena San-Martín

Montevideo, Uruguay

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Lara J Motta, PhD

CONTACT

11998829511; larajmotta@terra.com.br

Magdalena San-Martín, MD

CONTACT

11998829511; msanmartin@ucu.edu.uy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the researcher responsible for applying the laser will know which treatment was assigned to each participant. The researcher responsible for data collection will be blinded to the type of treatment received. The participant will be blind. The treatment with the control group will simulate the laser in operation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two groups: 1) the photobiomodulation experimental group (G1) , 2) the photobiomodulationn placebo group (G2) .

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: January 20, 2023
• Primary Completion: July 30, 2023
• Study Completion: November 20, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)