An interventional study of Photobiomodulation and Photobiomodulation- Sham in Caries,Dental, sponsored by University of Nove de Julho. Recruiting at 1 site in Uruguay. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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.
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.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Counted across the registry records on this site, refreshed daily.
nclusion criteria
Exclusion criteria
photobiomodulation application with the Laser Therapy XT device
Device: Photobiomodulation
photobiomodulation application with the Laser Therapy XT device off
Device: Photobiomodulation- Sham
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).
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).
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,
Time frame: three weeks
Saliva pH
aliva pH will be measured using a previously calibrated digital pH meter
Time frame: three weeks
Plan to share: No
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