Clinical trial NCT05546528: Photobiomodulation on Major Salivary Glands in Children With Caries Activity
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: dental caries
photobiomodulation
salivary flow
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: 1) the photobiomodulation experimental group (G1) , 2) the photobiomodulationn placebo group (G2) .
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Salivary flow
timeFrame: three weeks
Secondary outcomes:
measure: Saliva pH
timeFrame: three weeks
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Magdalena San-Martín
Study officials:
References: