Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Ibuprofen and Laser on Orthodontic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04070001
Recruitment Status : Completed
First Posted : August 27, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yeşim KAYA, Yuzuncu Yıl University

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.


Condition or disease Intervention/treatment Phase
Crowding, Tooth Drug: 400 Mg Ibuprofen Device: laser application Other: placebo tablets Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen group
Ibuprofen group received 1-dose 400-mg Ibuprofen 1 hour before elastomeric separator placement
Drug: 400 Mg Ibuprofen
1-dose 400-mg ibuprofen 1-hour before elastomeric separator placement

Active Comparator: Laser group
Laser groups received a single irradiation of low-level laser immediately after elastomeric separator placement.
Device: laser application
A single irradiation of laser after elastomeric separator placement

Placebo Comparator: Control group
Control group received placebo lactose tablets 1 hour before elastomeric separator placement.
Other: placebo tablets
Placebo lactose tablets 1-hour before elastomeric separator placement




Primary Outcome Measures :
  1. Evaluation the intensity of orthodontic pain after ibuprofen administration and laser application: levels of mediators such as interleukin 1-Beta and Substance P. [ Time Frame: This primary outcome was evaluated trough the study completion, on average of 1 year. ]
    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.

  2. Evaluation the intensity of orthodontic pain after ibuprofen administration and laser application: visual analogue scale. [ Time Frame: This primary outcome was evaluated trough the study completion, on average of 1 year. ]
    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.

  3. 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. [ Time Frame: This primary outcome was evaluated through the study completion, on average 1 year. ]
    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.

  4. Comparison of the effects of ibuprofen and laser therapy in alleviating orthodontic pain observed after elastomeric separator placement: visual analogue scale. [ Time Frame: This primary outcome was evaluated through the study completion, on average 1 year. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070001


Locations
Layout table for location information
Turkey
Van Yuzuncu Yıl University, Faculty of Dentistry
Van, Tuşba, Turkey, 65050
Sponsors and Collaborators
Yeşim KAYA

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Yeşim KAYA, Assistant professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT04070001     History of Changes
Other Study ID Numbers: 26.07.2017/04
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yeşim KAYA, Yuzuncu Yıl University:
Pain
Elastomeric separator
Laser
Ibuprofen
Gingival crevicular fluid
Additional relevant MeSH terms:
Layout table for MeSH terms
Ibuprofen
Malocclusion
Tooth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action