CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Ibuprofen +2 moredrug
Likely dose
Ibuprofen 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03568721
NCT03568721Phase 4Completed

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

Rio de Janeiro State University·interventional·Posted Jun 26, 2018·Updated Dec 3, 2018

In Brief

A Phase 4 clinical trial evaluating Ibuprofen, Acetaminophen, and 1 other intervention for Pain. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesBrazil

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartJan 25, 2015
Primary CompletionMar 18, 2018
Study CompletionMay 20, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.0 years ago

Interventions

Ibuprofendrug

prescription of ibuprofen 400 mg

Acetaminophendrug

prescription of acetaminophen 500 mg

Chewing gumother

prescription of one tablet of chewing gum