Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers.

NCT05924204 | Active Not Recruiting

• 1 other identifier: INFLAURU
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (3)

• pain control after placement of elastomeric spacers - baseline

  Visual analogue scale

  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

  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

  72 hours

Secondary Outcomes (6)

• Number of analgesics taken baseline

  baseline

• Number of analgesics taken 3 days

  3 days after procedure

• Local temperature baseline

  baseline

• Local temperature 24 hours

  24 hours

• The quality of life related to oral health baseline

  baseline

Study Arms (2)

G1 TREATMENT GROUP

EXPERIMENTAL

In the Treatment group the FMB with 4 J of energy by point

Radiation: Photobiomodulation

G2 SHAM GROUP

SHAM COMPARATOR

In the Sham group, the the device will be turned off

Other: Simulation of Photobiomodulation

Interventions

Photobiomodulation RADIATION

Application of photobiomodulation

G1 TREATMENT GROUP

Simulation of Photobiomodulation OTHER

Simulation of photobiomodulation

G2 SHAM GROUP

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

MeSH Terms

Conditions

Inflammation

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 29, 2023
• Study Start: March 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

BR (1)