The Effects of Ibuprofen and Laser on Orthodontic Pain

NCT04070001 | Completed

• 1 other identifier: 26.07.2017/04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain; Elastomeric separator; Laser; Ibuprofen; Gingival crevicular fluid

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

Ibuprofen group

ACTIVE COMPARATOR

Ibuprofen group received 1-dose 400-mg Ibuprofen 1 hour before elastomeric separator placement

Drug: 400 Mg Ibuprofen

Laser group

ACTIVE COMPARATOR

Laser groups received a single irradiation of low-level laser immediately after elastomeric separator placement.

Device: laser application

Control group

PLACEBO COMPARATOR

Control group received placebo lactose tablets 1 hour before elastomeric separator placement.

Other: placebo tablets

Interventions

400 Mg Ibuprofen DRUG

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

Ibuprofen group

laser application DEVICE

A single irradiation of laser after elastomeric separator placement

Laser group

placebo tablets OTHER

Placebo lactose tablets 1-hour before elastomeric separator placement

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous orthodontic treatment,
• Falling to complete the questionnaire and to continue to the follow-up appointments.

Sponsors & Collaborators

• Yeşim KAYA: lead

Study Sites (1)

Van Yuzuncu Yıl University, Faculty of Dentistry

Van, Tuşba, 65050, Turkey (Türkiye)

Location

Related Publications (6)

• Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.

  PMID: 17488999 BACKGROUND

• Nobrega 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: 10.1089/pho.2012.3338. Epub 2012 Nov 15.

  PMID: 23153291 RESULT

• 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/s40510-015-0104-y. Epub 2015 Oct 14.

  PMID: 26467790 RESULT

• 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. doi: 10.1016/j.jpain.2005.12.008.

  PMID: 16632326 RESULT

• 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. doi: 10.1016/j.ajodo.2006.11.019.

  PMID: 17920504 RESULT

• 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.

  PMID: 26132512 RESULT

MeSH Terms

Conditions

Malocclusion; Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)