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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetaminophen
* Other: Chewing gum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibuprofen<br>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<br>* prescription of ibuprofen 400 mg<br>* Other names: non steroidal drug;|
| Experimental: acetaminophen<br>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<br>* prescription of acetaminophen 500 mg<br>* Other names: paracetamol;|
| Experimental: chewing gum<br>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<br>* prescription of one tablet of chewing gum<br>|
| No Intervention: control<br>control (no reliever for orthodontic pain) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthodontic pain measurement by marking 100 millimeters visual analogue scales. | 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, orthodontics