Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement

NCT03568721 | Completed Phase 4

• 1 other identifier: 173112
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

pain; orthodontics

Outcome Measures

Primary Outcomes (1)

• Orthodontic pain measurement by marking 100 millimeters visual analogue scales.

  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 Outcomes (2)

• Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.

  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.

  2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.

Study Arms (4)

ibuprofen

EXPERIMENTAL

ibuprofen (400 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.

Drug: Ibuprofen

acetaminophen

EXPERIMENTAL

acetaminophen (500 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.

Drug: Acetaminophen

chewing gum

EXPERIMENTAL

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.

Other: Chewing gum

control

NO INTERVENTION

control (no reliever for orthodontic pain)

Interventions

Ibuprofen DRUG

prescription of ibuprofen 400 mg

Also known as: non steroidal drug

ibuprofen

Acetaminophen DRUG

prescription of acetaminophen 500 mg

Also known as: paracetamol

acetaminophen

Chewing gum OTHER

prescription of one tablet of chewing gum

chewing gum

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• moderate teeth crowding
• no need for tooth extraction to orthodontic reasons

You may not qualify if:

• presence of autoimmune diseases
• history of orthodontic treatment with fixed appliances

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Location

Related Publications (21)

• 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.

  PMID: 22284284 BACKGROUND

• 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.

  PMID: 23705940 BACKGROUND

• 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.

  PMID: 22515183 BACKGROUND

• 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.

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• 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.

  PMID: 14994886 BACKGROUND

• 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.

  PMID: 22989715 BACKGROUND

• 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.

  PMID: 14696738 BACKGROUND

• 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.

  PMID: 2750720 BACKGROUND

• 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.

  PMID: 8613507 BACKGROUND

• White LW. Pain and cooperation in orthodontic treatment. J Clin Orthod. 1984 Aug;18(8):572-5. No abstract available.

  PMID: 6595271 BACKGROUND

• 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.

  PMID: 17101023 BACKGROUND

• Simmons KE, Brandt M. Control of orthodontic pain. J Indiana Dent Assoc. 1992 Jul-Aug;71(4):8-10.

  PMID: 1432346 BACKGROUND

• 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.

  PMID: 23210546 BACKGROUND

• 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.

  PMID: 1927986 BACKGROUND

• 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.

  PMID: 18331926 BACKGROUND

• 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.

  PMID: 8921656 BACKGROUND

• 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.

  PMID: 11455373 BACKGROUND

• 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.

  PMID: 1456222 BACKGROUND

• 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.

  PMID: 22259810 BACKGROUND

• 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.

  PMID: 19361739 BACKGROUND

• 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.

  PMID: 21195257 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; GDF15 protein, human; Acetaminophen; Chewing Gum

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• DIEGO J SANTOS, MSc

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

• JONAS CAPELLI, PhD

  Rio de Janeiro State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: June 26, 2018
• Study Start: January 25, 2015
• Primary Completion: March 18, 2018
• Study Completion: May 20, 2018
• Last Updated: December 3, 2018

Record last verified: 2018-11

Locations

BR (1)