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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Ibuprofen; Other: Chewing gum; Drug: Acetaminophen

• Registration Number: NCT03568721
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-25
• Primary Completion: 2018-03-18
• Study Completion: 2018-05-20
• Study First Submitted: 2018-06-02
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen	Ibuprofen	ibuprofen (400 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
chewing gum	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.
acetaminophen	Acetaminophen	acetaminophen (500 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Rio de Janeiro State University; 🇧🇷 Rio de Janeiro, Brazil