NCT04070001

The Effects of Ibuprofen and Laser on Orthodontic Pain

Completed NA Last updated 29 August 2019

What this trial tests

NA trial testing 400 Mg Ibuprofen in Crowding, Tooth in 60 participants. Completed in 1 August 2018.

Timeline

1 August 2017

Primary endpoint
1 August 2018

1 August 2018

Quick facts

Lead sponsor	Yeşim KAYA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	1 August 2017
Primary completion	1 August 2018
Estimated completion	1 August 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• 400 Mg Ibuprofen — full drug profile →
• laser application
• placebo tablets — full drug profile →

Conditions studied

• Crowding, Tooth — all drugs for Crowding, Tooth →

Sponsor

Yeşim KAYA — full company profile →

Who can join

Adults 18 to 30, any sex, with Crowding, Tooth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.