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Completed

NCT Number: NCT03568721

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

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.

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Key information

Conditions

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

Age range

12 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

prescription of ibuprofen 400 mg

Other names: non steroidal drug

Acetaminophen

Drug

prescription of acetaminophen 500 mg

Other names: paracetamol

Chewing Gum

Other

prescription of one tablet of chewing gum

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial

Acronym: PECI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Dec 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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