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

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:
  • 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.
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.
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.

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

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

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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