Photobiomodulation Efficacy of Major Salivary Glands in Children With Caries Activity: Study Protocol for Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Nove de Julho
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Salivary flow
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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.
Arms & Interventions
photobiomodulation
photobiomodulation application with the Laser Therapy XT device
Intervention: Photobiomodulation (Device)
photbiomodulation-sham
photobiomodulation application with the Laser Therapy XT device off
Intervention: Photobiomodulation- Sham (Device)
Outcomes
Primary Outcomes
Salivary flow
Time Frame: 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 Outcomes
- Saliva pH(three weeks)
Investigators
Lara Jansiski Motta
Principal Investigator
University of Nove de Julho