Photobiomodulation on Major Salivary Glands in Children With Caries Activity

Sponsor

University of Nove de Julho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05546528

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries,Dental	Device: Photobiomodulation Device: Photobiomodulation- Sham	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 20, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Nov 20, 2023

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Saliva pH [three weeks]
aliva pH will be measured using a previously calibrated digital pH meter

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nove de Julho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lara Jansiski Motta, Principal Investigator, University of Nove de Julho

ClinicalTrials.gov Identifier:

NCT05546528

Other Study ID Numbers:

PMBSalivaCaries

First Posted:

Sep 19, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lara Jansiski Motta, Principal Investigator, University of Nove de Julho

dental caries

photobiomodulation

salivary flow

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Sep 21, 2022