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

Sponsor
Rio de Janeiro State University (Other)
Overall Status
Completed
CT.gov ID
NCT03568721
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
81
Enrollment
1
Location
4
Arms
39.8
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Jan 25, 2015
Actual Primary Completion Date :
Mar 18, 2018
Actual Study Completion Date :
May 20, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • 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)

    Outcome Measures

    Primary Outcome Measures

    1. Orthodontic pain measurement by marking 100 millimeters visual analogue scales. [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. [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: DIEGO J SANTOS, MSc, Rio de Janeiro State University
    • Study Director: JONAS CAPELLI, PhD, Rio de Janeiro State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Diego Junior da Silva Santos, DDS,MsD, Principal Investigator, Rio de Janeiro State University
    ClinicalTrials.gov Identifier:
    NCT03568721
    Other Study ID Numbers:
    • 173112
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    Dec 3, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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, Principal Investigator, Rio de Janeiro State University
    pain
    orthodontics
    Additional relevant MeSH terms:
    Acetaminophen
    Ibuprofen

    Study Results

    No Results Posted as of Dec 3, 2018