- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03568721
Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement (PECI)
November 29, 2018 updated by: Diego Junior da Silva Santos, DDS,MsD, Rio de Janeiro State University
Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial
The purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum in reducing orthodontic pain.
This study include 81 patients to be classified into 4 groups of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control.
The patients in each group will receive 1 method immediately after placement of the initial archwire and every 6 hours for a week if they experiences pain.
Pain perception will be recorded by the patients while jaw rest position and fitting back teeth at 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement, using a visual analog scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rio de Janeiro, Brazil, 20551-030
- Rio de Janeiro State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 55 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- moderate teeth crowding
- no need for tooth extraction to orthodontic reasons
Exclusion Criteria:
- presence of autoimmune diseases
- history of orthodontic treatment with fixed appliances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ibuprofen
ibuprofen (400 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
|
prescription of ibuprofen 400 mg
Other Names:
|
Experimental: acetaminophen
acetaminophen (500 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
|
prescription of acetaminophen 500 mg
Other Names:
|
Experimental: chewing gum
chewing gum (01 tablet) immediately after insertion of the initial archwire and 6/6 hs of chewing gum for a week if there is any orthodontic pain.
|
prescription of one tablet of chewing gum
|
No Intervention: control
control (no reliever for orthodontic pain)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Orthodontic pain measurement by marking 100 millimeters visual analogue scales.
Time Frame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
|
to compare the efficacy of ibuprofen, acetaminophen and chewing gum in changing orthodontic pain by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points.
|
2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.
Time Frame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
|
to verify if chewing gum can be a non-pharmacologic method for orthodontic pain control by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and ends to the right (exacerbated pain) at different time points.
|
2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
|
Pain at rest X fitting back teeth by marking 100 millimeters visual analogue scales.
Time Frame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
|
to verify wich group has less pain and if in rest or in fitting back teeth by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points.
|
2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DIEGO J SANTOS, MSc, Rio de Janeiro State University
- Study Director: JONAS CAPELLI, PhD, Rio de Janeiro State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x.
- Sandhu SS, Sandhu J. Orthodontic pain: an interaction between age and sex in early and middle adolescence. Angle Orthod. 2013 Nov;83(6):966-72. doi: 10.2319/030113-174.1. Epub 2013 May 24.
- Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
- Cioffi I, Piccolo A, Tagliaferri R, Paduano S, Galeotti A, Martina R. Pain perception following first orthodontic archwire placement--thermoelastic vs superelastic alloys: a randomized controlled trial. Quintessence Int. 2012 Jan;43(1):61-9.
- Farzanegan F, Zebarjad SM, Alizadeh S, Ahrari F. Pain reduction after initial archwire placement in orthodontic patients: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):169-73. doi: 10.1016/j.ajodo.2011.06.042.
- Angelopoulou MV, Vlachou V, Halazonetis DJ. Pharmacological management of pain during orthodontic treatment: a meta-analysis. Orthod Craniofac Res. 2012 May;15(2):71-83. doi: 10.1111/j.1601-6343.2012.01542.x.
- Erdinc AM, Dincer B. Perception of pain during orthodontic treatment with fixed appliances. Eur J Orthod. 2004 Feb;26(1):79-85. doi: 10.1093/ejo/26.1.79.
- Canavarro C, Teles RP, Capelli Junior J. Matrix metalloproteinases -1, -2, -3, -7, -8, -12, and -13 in gingival crevicular fluid during orthodontic tooth movement: a longitudinal randomized split-mouth study. Eur J Orthod. 2013 Oct;35(5):652-8. doi: 10.1093/ejo/cjs053. Epub 2012 Sep 17.
- Davies GM, Worthington HV, Ellwood RP, Blinkhorn AS, Taylor GO, Davies RM, Considine J. An assessment of the cost effectiveness of a postal toothpaste programme to prevent caries among five-year-old children in the North West of England. Community Dent Health. 2003 Dec;20(4):207-10.
- Hwang JY, Tee CH, Huang AT, Taft L. Effectiveness of thera-bite wafers in reducing pain. J Clin Orthod. 1994 May;28(5):291-2. No abstract available.
- White LW. Pain and cooperation in orthodontic treatment. J Clin Orthod. 1984 Aug;18(8):572-5. No abstract available.
- Krishnan V, Davidovitch Z. The effect of drugs on orthodontic tooth movement. Orthod Craniofac Res. 2006 Nov;9(4):163-71. doi: 10.1111/j.1601-6343.2006.00372.x.
- Simmons KE, Brandt M. Control of orthodontic pain. J Indiana Dent Assoc. 1992 Jul-Aug;71(4):8-10.
- Keith DJ, Rinchuse DJ, Kennedy M, Zullo T. Effect of text message follow-up on patient's self-reported level of pain and anxiety. Angle Orthod. 2013 Jul;83(4):605-10. doi: 10.2319/091812-742.1. Epub 2012 Dec 4.
- Brown DF, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. Am J Orthod Dentofacial Orthop. 1991 Oct;100(4):349-56. doi: 10.1016/0889-5406(91)70073-6.
- Bergius M, Broberg AG, Hakeberg M, Berggren U. Prediction of prolonged pain experiences during orthodontic treatment. Am J Orthod Dentofacial Orthop. 2008 Mar;133(3):339.e1-8. doi: 10.1016/j.ajodo.2007.09.013.
- Scheurer PA, Firestone AR, Burgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 Aug;18(4):349-57. doi: 10.1093/ejo/18.4.349.
- Bernhardt MK, Southard KA, Batterson KD, Logan HL, Baker KA, Jakobsen JR. The effect of preemptive and/or postoperative ibuprofen therapy for orthodontic pain. Am J Orthod Dentofacial Orthop. 2001 Jul;120(1):20-7. doi: 10.1067/mod.2001.115616.
- Jones M, Chan C. The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires. Am J Orthod Dentofacial Orthop. 1992 Oct;102(4):373-81. doi: 10.1016/0889-5406(92)70054-e.
- Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020.
- Patel S, McGorray SP, Yezierski R, Fillingim R, Logan H, Wheeler TT. Effects of analgesics on orthodontic pain. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e53-8. doi: 10.1016/j.ajodo.2010.07.017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2015
Primary Completion (Actual)
March 18, 2018
Study Completion (Actual)
May 20, 2018
Study Registration Dates
First Submitted
June 2, 2018
First Submitted That Met QC Criteria
June 22, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Acetaminophen
- Ibuprofen
Other Study ID Numbers
- 173112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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