Crowding, Tooth Clinical Trial
Official title:
Comparison of the Effects of Ibuprofen and Low-Level Laser Therapy on Orthodontic Pain By Means of Interleukin 1-Beta and Substance P Levels in the Gingival Crevicular Fluid
Verified date | August 2019 |
Source | Yuzuncu Yil University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Being older than 18 years of age, - Requiring ESP at the beginning of orthodontic treatment for banding of maxillary first molars, - Intact maxillary dentition (exception of third molars), - Fully erupted maxillary first molars without any treated or not treated apical lesions, - Tight contacts between the posterior teeth, - No pregnancy and lactation, - The absence of systemic and periodontal diseases and chronic or neural pains, - Currently not using analgesics or antibiotics that interfere the pain perception, - No contradiction to the use of ibuprofen, - The absence of gingival pigmentation where the laser will be applied. Exclusion Criteria: - Previous orthodontic treatment, - Falling to complete the questionnaire and to continue to the follow-up appointments. |
Country | Name | City | State |
---|---|---|---|
Turkey | Van Yuzuncu Yil University, Faculty of Dentistry | Van | Tusba |
Lead Sponsor | Collaborator |
---|---|
Yesim KAYA |
Turkey,
Bird SE, Williams K, Kula K. Preoperative acetaminophen vs ibuprofen for control of pain after orthodontic separator placement. Am J Orthod Dentofacial Orthop. 2007 Oct;132(4):504-10. — View Citation
Farias RD, Closs LQ, Miguens SA Jr. Evaluation of the use of low-level laser therapy in pain control in orthodontic patients: A randomized split-mouth clinical trial. Angle Orthod. 2016 Mar;86(2):193-8. doi: 10.2319/122214-933.1. Epub 2015 Jul 1. — View Citation
Giannopoulou C, Dudic A, Kiliaridis S. Pain discomfort and crevicular fluid changes induced by orthodontic elastic separators in children. J Pain. 2006 May;7(5):367-76. — View Citation
Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. Review. — View Citation
Nóbrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10 — View Citation
Zarif Najafi H, Oshagh M, Salehi P, Babanouri N, Torkan S. Comparison of the effects of preemptive acetaminophen, ibuprofen, and meloxicam on pain after separator placement: a randomized clinical trial. Prog Orthod. 2015;16:34. doi: 10.1186/s40510-015-010 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation the intensity of orthodontic pain after ibuprofen administration and laser application: levels of mediators such as interleukin 1-Beta and Substance P. | The intensity of pain observed after elastomeric separator placement was evaluated through levels of mediators such as interleukin 1-Beta and Substance P in gingival crevicular fluid objectively. | This primary outcome was evaluated trough the study completion, on average of 1 year. | |
Primary | Evaluation the intensity of orthodontic pain after ibuprofen administration and laser application: visual analogue scale. | The intensity of pain observed after elastomeric separator placement was evaluated through visual analogue scale subjectively. Visual analogue scale is a 10-cm horizontal line with the number 0 representing no pain and the number 10 representing the worst pain. | This primary outcome was evaluated trough the study completion, on average of 1 year. | |
Primary | Comparison of the effects of ibuprofen and laser therapy in alleviating orthodontic pain observed after elastomeric separator placement: evels of mediators such as interleukin 1-Beta and Substance P. | The intensity of pain observed after elastomeric separator placement was evaluated through levels of mediators such as interleukin 1-Beta and Substance P in gingival crevicular fluid objectively. | This primary outcome was evaluated through the study completion, on average 1 year. | |
Primary | Comparison of the effects of ibuprofen and laser therapy in alleviating orthodontic pain observed after elastomeric separator placement: visual analogue scale. | The intensity of pain observed after elastomeric separator placement was evaluated through visual analogue scale subjectively.Visual analogue scale is a 10-cm horizontal line with the number 0 representing no pain and the number 10 representing the worst pain. | This primary outcome was evaluated through the study completion, on average 1 year. |
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