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

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ClinicalTrials.gov Identifier: NCT03568721
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Diego Junior da Silva Santos, DDS,MsD, Rio de Janeiro State University

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ibuprofen Drug: Acetaminophen Other: Chewing gum Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial
Actual Study Start Date : January 25, 2015
Actual Primary Completion Date : March 18, 2018
Actual Study Completion Date : May 20, 2018

Resource links provided by the National Library of Medicine


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.
Drug: Ibuprofen
prescription of ibuprofen 400 mg
Other Name: non steroidal drug

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.
Drug: Acetaminophen
prescription of acetaminophen 500 mg
Other Name: paracetamol

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.
Other: Chewing gum
prescription of one tablet of chewing gum

No Intervention: control
control (no reliever for orthodontic pain)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03568721


Locations
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Brazil
Rio de Janeiro State University
Rio de Janeiro, Brazil, 20551-030
Sponsors and Collaborators
Rio de Janeiro State University
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: DIEGO J SANTOS, MSc Rio de Janeiro State University
Study Director: JONAS CAPELLI, PhD Rio de Janeiro State University

Publications:

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Responsible Party: Diego Junior da Silva Santos, DDS,MsD, Principal Investigator, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03568721     History of Changes
Other Study ID Numbers: 173112
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Diego Junior da Silva Santos, DDS,MsD, Rio de Janeiro State University:
pain
orthodontics

Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action