InflammationNCT05924204
Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers.
A study testing Photobiomodulation and Simulation of Photobiomodulation in people with Inflammation, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Recent studies have shown that photobiomodulation (FBM) can modulate pain after the placement of elastomeric separators, however, to date, there is no ideal protocol for its application. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Photobiomodulation and Simulation of Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2024to 30 Nov 2024
- 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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients will include:
- With the need to place bilateral orthodontic bands on the lower first molars.
- Age 13 to 30 years old.
- Both sexes.
- No comorbidities.
- Never used orthodontic appliances.
- Preserved surrounding spaces.
- Healthy permanent dentition with good hygiene.
Who cannot join
- Patients will be excluded:
- Who are taking drugs that affect bone metabolism and the inflammatory process (for example corticosteroids, bisphosphonates), who have used anti-inflammatory drugs or analgesics for less than 1 week since placing elastomeric separators.
- Present general pathologies (craniofacial anomalies) and local ones (dental anomalies) that affect the result of the movement of the teeth,
- Smokers, embarrassed, or breastfeeding women.
- Allergic to paracetamol®
- During the investigation, another different drug was used, which was made available by the investigators, and the patient was informed about this alteration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers: a Randomized Controlled Trial.
Recent studies have shown that photobiomodulation (FBM) can modulate pain after the placement of elastomeric separators, however, to date, there is no ideal protocol for its application. Therefore, the objective of this study will be to evaluate the effect of photobiomodulation on pain control 24 hours after the placement of elastomeric separators using the visual analog scale (VAS). 25 patients between 13 and 30 years old with the need for the placement of orthodontic bands in the lower first molars bilaterally will be included, which establishes a sample of fifty molars.
Elastomeric separators will be placed on the mesial and distal surfaces of the right and left molars. Treatment will be randomized to the right molar and the opposite treatment will be applied to the left side. The study groups will be G1 (experimental) - elastomeric separators + FBM (diode laser, 808nm, 100mw power, with 2 J, 3 points per vestibular and 3 points per palatal, single session, 707J/cm2) and G2-(control)- elastomeric separators + FBM simulation. The patient and the evaluator will be blinded to the intervention performed. The primary outcome variable will be spontaneous pain assessed 24 hours after the placement of elastomeric separators measured with the VAS scale. Secondary outcome variables will be pain during mastication (measured with the VAS scale), count of the number of analgesics (paracetamol), local temperature (measured with a digital thermometer), and assess the impact of oral health on quality of life. of the participant, the OHIP-14 questionnaire will be applied. These outcomes will be evaluated at baseline, 24 with the presence of the participant, and 72 hours after the placement of elastomeric separators. If the data are normal, they will be submitted to the ANOVA - one-way test. Data will be presented as means ± SD and the p-value will be set to < 0.05.
Read the detailed description
This randomized, controlled, double-blind, split-mouth clinical trial meets the criteria for designing a clinical study under the conditions of the SPIRIT Statement. The study was approved by the Committee for Ethics in Research (CEP) of the Universidad Católica del Uruguay. The participants who will be recruited are patients who are undergoing orthodontic treatment at the Orthodontic Clinic of the Specialization Course in Orthopedics and Orthodontics at the Catholic University of Uruguay in the city of Montevideo, Uruguay; those who require the installation of bands on the lower first permanent molars.
Any change or change will be reported and clarified to the CEP and informed in publications. A copy of the signed informed consent will be sent to the participant by email (completed in the TCLE). The project will be registered at www.clinicaltrial.gov There is no conflict of interest about any product used in the work and about any author involved in the studio. The data will be published and there will be no restriction on the inclusion of data for publication. All data will be available for your consultation, and all patients will have access to their medical records at any time they wish.
- Conditions
- Inflammation
- Being tested
- Photobiomodulation, Simulation of Photobiomodulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
Application of photobiomodulation
Simulation of PhotobiomodulationOther
Simulation of photobiomodulation
| Study group | Role | What they receive |
|---|---|---|
| G1 TREATMENT GROUP | Experimental | In the Treatment group the FMB with 4 J of energy by point Receives: Radiation: Photobiomodulation |
| G2 SHAM GROUP | Sham comparator | In the Sham group, the the device will be turned off Receives: Other: Simulation of Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain control after placement of elastomeric spacers - baseline
Visual analogue scale
Measured: baseline
pain control after placement of elastomeric spacers - 24 hours
Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life
Measured: 24 hours
pain control after placement of elastomeric spacers - 72 hours
Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life
Measured: 72 hours
Secondary outcomes (6)
Number of analgesics taken baseline
The analgesic used will only be paracetamol. It will be used only if there is pain.
Measured: baseline
Number of analgesics taken 3 days
The analgesic used will only be paracetamol. It will be used only if there is pain.
Measured: 3 days after procedure
Local temperature baseline
evaluated using a digital thermometer
Measured: baseline
Local temperature 24 hours
evaluated using a digital thermometer
Measured: 24 hours
The quality of life related to oral health baseline
will be evaluated using the OHIP-14 questionnaire
Measured: baseline
The quality of life related to oral health -72 hours
will be evaluated using the OHIP-14 questionnaire
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start30 Mar 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924204
- Sponsor's protocol ID
- INFLAURU
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05924204
- Acronym / sponsor ID
- INFLAURU
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Jun 2023 (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.
Recent studies have shown that photobiomodulation (FBM) can modulate pain after the placement of elastomeric separators, however, to date, there is no ideal protocol for its application. Therefore, the objective of this study will be to evaluate the effect of photobiomodulation on pain control 24 hours after the placement of elastomeric separators using the visual analog scale (VAS). 25 patients between 13 and 30 years old with the need for the placement of orthodontic bands in the lower first molars bilaterally will be included, which establishes a sample of fifty molars.
Elastomeric separators will be placed on the mesial and distal surfaces of the right and left molars. Treatment will be randomized to the right molar and the opposite treatment will be applied to the left side. The study groups will be G1 (experimental) - elastomeric separators + FBM (diode laser, 808nm, 100mw power, with 2 J, 3 points per vestibular and 3 points per palatal, single session, 707J/cm2) and G2-(control)- elastomeric separators + FBM simulation. The patient and the evaluator will be blinded to the intervention performed. The primary outcome variable will be spontaneous pain assessed 24 hours after the placement of elastomeric separators measured with the VAS scale. Secondary outcome variables will be pain during mastication (measured with the VAS scale), count of the number of analgesics (paracetamol), local temperature (measured with a digital thermometer), and assess the impact of oral health on quality of life. of the participant, the OHIP-14 questionnaire will be applied. These outcomes will be evaluated at baseline, 24 with the presence of the participant, and 72 hours after the placement of elastomeric separators. If the data are normal, they will be submitted to the ANOVA - one-way test. Data will be presented as means ± SD and the p-value will be set to < 0.05.
Detailed description
This randomized, controlled, double-blind, split-mouth clinical trial meets the criteria for designing a clinical study under the conditions of the SPIRIT Statement. The study was approved by the Committee for Ethics in Research (CEP) of the Universidad Católica del Uruguay. The participants who will be recruited are patients who are undergoing orthodontic treatment at the Orthodontic Clinic of the Specialization Course in Orthopedics and Orthodontics at the Catholic University of Uruguay in the city of Montevideo, Uruguay; those who require the installation of bands on the lower first permanent molars.
Any change or change will be reported and clarified to the CEP and informed in publications. A copy of the signed informed consent will be sent to the participant by email (completed in the TCLE). The project will be registered at www.clinicaltrial.gov There is no conflict of interest about any product used in the work and about any author involved in the studio. The data will be published and there will be no restriction on the inclusion of data for publication. All data will be available for your consultation, and all patients will have access to their medical records at any time they wish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 TREATMENT GROUP | Experimental | Radiation: PhotobiomodulationIn the Treatment group the FMB with 4 J of energy by point |
| G2 SHAM GROUP | Sham comparator | Other: Simulation of PhotobiomodulationIn the Sham group, the the device will be turned off |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients will include:
Key exclusion criteria (6 listed)
- Patients will be excluded:
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 |
|---|---|---|
| PhotobiomodulationApplication of photobiomodulation | Radiation | G1 TREATMENT GROUP |
| Simulation of PhotobiomodulationSimulation of photobiomodulation | Other | G2 SHAM GROUP |
Primary outcome
pain control after placement of elastomeric spacers - baseline
Time frame: baseline
Visual analogue scale
pain control after placement of elastomeric spacers - 24 hours
Time frame: 24 hours
Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life
pain control after placement of elastomeric spacers - 72 hours
Time frame: 72 hours
Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life
6 secondary outcomes
Number of analgesics taken baseline
Time frame: baseline
Number of analgesics taken 3 days
Time frame: 3 days after procedure
Local temperature baseline
Time frame: baseline
Local temperature 24 hours
Time frame: 24 hours
The quality of life related to oral health baseline
Time frame: baseline
The quality of life related to oral health -72 hours
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Simulation of Photobiomodulation in people with Inflammation, run by University of Nove de Julho at 1 site in Brazil.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jul 2026. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain control after placement of elastomeric spacers - baseline (time frame: baseline). The study lists 3 primary outcomes in all. 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 29 Jul 2026.