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The Effects of Ibuprofen and Laser on Orthodontic Pain

NCT04070001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-29

No results posted yet for this study

Summary

Early orthodontic pain is usually caused by the insertion of elastomeric separators to the mesial and distal of the tooth to be banded in order to create adequate space for proper placement. Recent studies have demonstrated that the pain reaches its peak at 24 hours and then gradually decreases within 7 days The intensity of this pain is sometimes perceived as extremely high to cause a significant number of patients to discontinue the treatment.

Nonsteroidal anti-inflammatory drugs, which block the prostaglandin synthesis through inhibiting the cyclooxygenase activity, is one of the most common methods used to manage the orthodontic pain. It has been reported that these drugs decrease the orthodontic tooth movement rate, in addition to many systemic side effects such as gastric and duodenal ulceration, coagulation disorders, congestive heart problems and allergic effect.

The application of low-level laser therapy (LLLT) also reported being efficient in accelerating orthodontic tooth movement and in alleviating orthodontic pain without any apparent side effects. LLLT is thought to reduce the pain by increasing the local blood flow, inhibiting the secretion of inflammatory substances, inducing the release of neurotransmitters, altering the conduction and excitation of peripheral nerves and stimulating the endorphins release. On the other hand, literature review on the effectiveness of LLLT in alleviating orthodontic pain observed after elastomeric separator placement (ESP) exhibited conflicting results. While LLLT was found to be effective in some studies, the others refuted its effectiveness.

When studies on alleviating orthodontic pain observed after ESP were reviewed, it was determined that the effects of many drugs and LLLT were evaluated subjectively by VAS. Furthermore, only in one study, the effects of ibuprofen and LLLT were compared using PGE2 levels in GCF and VAS. Based on that, this study was aimed to compare the effects of ibuprofen and LLLT in alleviating orthodontic pain observed after ESP through IL-1β and SP levels in GCF and VAS.

Conditions

  • Crowding, Tooth

Interventions

DRUG

400 Mg Ibuprofen

1-dose 400-mg ibuprofen 1-hour before elastomeric separator placement

DEVICE

laser application

A single irradiation of laser after elastomeric separator placement

OTHER

placebo tablets

Placebo lactose tablets 1-hour before elastomeric separator placement

Sponsors & Collaborators

  • Yeşim KAYA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-08-01
Completion
2018-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04070001 on ClinicalTrials.gov