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Clinical trial to evaluate the effectiveness and safety of the laser to control the pain caused by orthodontic treatment

Evaluation of low level laser terapy(LLLT) for the treatment of pain associated with positioning elastomeric orthodontic interdental separators - LASER: Light Amplification by Stimulated Emission of Radiation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8v3tkq
Enrollment
Unknown
Registered
2012-05-28
Start date
2011-06-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental malocclusion

Interventions

60 orthodontic patients were randomly assigned to two groups of 30 individuals per group (ages 12-25 years with an average of 17.1 for group A
ages 12-26 years with an average of 17.9 for group B). The patients received elastomeric separators on the mesial and distal surfaces of one of the lower first molars, and immediately after insertion
infrared). The control group received irradiation with the placebo light, as a single spot application in the region of the radicular apex and as three spots along the radicular axis, for the vestibul
device
E02.594.540

Sponsors

Universidade Federal de São Paulo - UNIFESP
Lead Sponsor
Universidade Federal de São Paulo - UNIFESP
Collaborator

Eligibility

Age
12 Years to 40 Years

Inclusion criteria

Inclusion criteria: Chronological age greater than 12 years; Presence of erupted permanent first and second lower molars; Presence of erupted first and second premolars; Voluntary participation in the study confirmed by signing the informed consent form.

Exclusion criteria

Exclusion criteria: Patients using antibiotics or analgesics; Pregnant or breastfeeding women; Patients with cardiac disease; Systemic diseases; Contraindications for NSAIDs use; Surgical procedure during the preceding two weeks; Gastrointestinal illness (gastritis, gastric ulcer, lactose intolerance, chronic diarrhea or intestinal inflammatory illness); Melanin pigmentation in the gingiva in the area to be irradiated; Treated or untreated apical bone lesions; Diastema in the region of the molars and/or premolars.

Design outcomes

Primary

MeasureTime frame
The volunteers received a questionnaire asking about pain intensity, to be defined on a visual analogue scale, which they filled out during the days of the week subsequent to the procedure. The patients marked the pain intensity in situations with a relaxed mouth (spontaneous pain) and upon biting only with the posterior teeth (in occlusion). The intensity of pain was reported by the patients 2, 6 and 24 hours and 3 and 5 days after orthodontic separator placement.

Countries

Brazil

Contacts

Public ContactCelestino;Edina Nobrega;Koga da Silva

unifesp;unifesp

celestino@ortogeo.com.br;edinaksilva@terra.com.br(012)33029980;(012)33029980

Outcome results

None listed

Source: REBEC (via WHO ICTRP)