Caries,DentalNCT05546528
Photobiomodulation on Major Salivary Glands in Children With Caries Activity
A study testing Photobiomodulation in people with Caries,Dental, run by University of Nove de Julho at 1 site in Uruguay.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUruguay
- Study dates
- 20 Jan 2023to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uruguay1 site, 1 recruiting
- Recruiting
Magdalena San-Martín
Montevideo
Magdalena San-Martín, MD, 11998829511, msanmartin@ucu.edu.uy
About this study
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
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.
Read the 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.
- Conditions
- Caries,Dental
- Being tested
- Photobiomodulation, Photobiomodulation- Sham
- Keywords
- dental caries, photobiomodulation, salivary flow
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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- ShamDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| photobiomodulation | Experimental | photobiomodulation application with the Laser Therapy XT device Receives: Device: Photobiomodulation |
| photbiomodulation-sham | Sham comparator | photobiomodulation application with the Laser Therapy XT device off Receives: Device: Photobiomodulation- Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: three weeks
Secondary outcomes (1)
Saliva pH
aliva pH will be measured using a previously calibrated digital pH meter
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start20 Jan 2023
- Primary completion30 Jul 2023
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups: 1) the photobiomodulation experimental group (G1) , 2) the photobiomodulationn placebo group (G2) .
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546528
- Sponsor's protocol ID
- PMBSalivaCaries
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05546528
- Acronym / sponsor ID
- PMBSalivaCaries
- Conditions
- Caries,Dental
- Keywords
- dental caries, photobiomodulation, salivary flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups: 1) the photobiomodulation experimental group (G1) , 2) the photobiomodulationn placebo group (G2) .
| Arm | Type | Receives |
|---|---|---|
| photobiomodulation | Experimental | Device: Photobiomodulationphotobiomodulation application with the Laser Therapy XT device |
| photbiomodulation-sham | Sham comparator | Device: Photobiomodulation- Shamphotobiomodulation application with the Laser Therapy XT device off |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationG1 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). | Device | photobiomodulation |
| Photobiomodulation- ShamG2 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). | Device | photbiomodulation-sham |
Primary outcome
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,
1 secondary outcome
Saliva pH
Time frame: three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Caries,Dental, run by University of Nove de Julho at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara J Motta, PhD (11998829511, larajmotta@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flow (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.