Analgesic efficacy of transdermal patches versus oral tablets on pain control of orthodontic patients

Phase 4

Recruiting

• Conditions: pain after initial arch wire placement in orthodontic patients.

• Registration Number: IRCT20190915044771N2
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients who want to start fixed orthodontic treatment of 2 jaws.
Patients should be in the age range of 18 to 30 years.
Patients should be healthy in terms of physical condition, without any systemic disease and according to the classification of the American Society of Anesthesiology should be in ASA I group.
Based on Little's Irregularity Index, patients should have 3-6 mm of crowding in both upper and lower jaws and do not need tooth extraction.
Patients should not take any medication at the moment.
Patients should not report a history of bleeding or gastrointestinal discomfort or any allergies after taking Asprin-like drugs such as ibuprofen, and should not have any problems using ketoprofen, diclofenac, and ibuprofen.

Exclusion Criteria

Patients who have taken any painkiller within 24 hours before treatment.
Patients who cannot give informed consent.
Patients who are illiterate.
Patients who need restoration, root canal treatment or extraction of their teeth.
Patients who have spontaneous pain in their teeth or periodontal problems do not allow to start orthodontic treatment.
Patients who are pregnant or breastfeeding their babies.
Patients who have a history of liver or kidney diseases or take drugs that affect these 2 organs.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity after initial arch wire placement in orthodontic patients. Timepoint: Immediately after arch wire placement and 2, 6 hours later, while sleeping, 24, 48 hours, 3 and 7 days after treatment. Method of measurement: Numerical rating scale (NRS).