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

Rio de Janeiro State University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Acetaminophen; Drug: Ibuprofen; Other: Chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT03568721

173112

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 4 patient groups

ibuprofen

Experimental group

Description:

ibuprofen (400 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.

Treatment:

Drug: Ibuprofen

acetaminophen

Experimental group

Description:

acetaminophen (500 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.

Treatment:

Drug: Acetaminophen

chewing gum

Experimental group

Description:

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.

Treatment:

Other: Chewing gum

control

No Intervention group

Description:

control (no reliever for orthodontic pain)