Photobiomodulation on Major Salivary Glands in Children With Caries Activity
NCT ID: NCT05546528
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-01-20
2023-11-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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photobiomodulation
photobiomodulation application with the Laser Therapy XT 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).
photbiomodulation-sham
photobiomodulation application with the Laser Therapy XT device off
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).
Interventions
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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).
Eligibility Criteria
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Exclusion Criteria
* 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.
6 Years
12 Years
ALL
Yes
Sponsors
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University of Nove de Julho
OTHER
Responsible Party
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Lara Jansiski Motta
Principal Investigator
Locations
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Magdalena San-Martín
Montevideo, , Uruguay
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMBSalivaCaries
Identifier Type: -
Identifier Source: org_study_id
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