Photobiomodulation on Major Salivary Glands in Children With Caries Activity

Caries,Dental Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546528
• Other study ID #: PMBSalivaCaries
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: September 2023
• Source: University of Nove de Julho
• Contact: Lara J Motta, PhD
• Phone: 11998829511
• Email: larajmotta[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 20, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

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).
• 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).

Locations

Country	Name	City	State
Uruguay	Magdalena San-Martín	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Saliva pH	aliva pH will be measured using a previously calibrated digital pH meter	three weeks