A Comparative Assessment of Post Extraction Pain in Orthodontic Patients to Evaluate the Effects of Early Engagement of Tooth with Orthodontic Wires. a Single Center Randomized Clinical Trial (RCT)

Not Applicable

Completed

• Conditions: Orthodontic Extraction; Orthodontic Treatment; Orthodontic Treatment Via Premolar Extraction

• Registration Number: NCT06582836
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

The goal of this clinical trial is to determine if the timing of tooth extractions (before or after initial orthodontic treatment) affects pain levels in patients who need bilateral extractions of first premolars in the upper jaw. The participants in this study are patients who require these extractions as part of their orthodontic treatment.

The main questions it aims to answer are:

1. Does extracting teeth before starting orthodontic treatment result in different pain levels compared to extracting teeth after alignment?

2. How do pain levels change over time after the extractions in each group?

Researchers will compare Group A (patients who have extractions before orthodontic treatment) to Group B (patients who have extractions after initial alignment) to see if the timing of the extractions affects pain levels.

Participants will:

Undergo tooth extractions either before or after initial alignment based on their group.

Rate their pain on an 11-point numerical rating scale at various times (2, 4, 8, 12, and 24 hours after extraction, and then daily for a week).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-10
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Status Verified: 2024-08
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 12 to 18-year-old orthodontic patients needing bilaterally symmetrical extractions of first premolars as a part of orthodontic treatment. Angles class I with moderate to severe crowding cases, bimaxillary proclination, and Angles class II division 1 were included.

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Exclusion Criteria

• Patients with poor oral hygiene, carious or missing premolars, multiple missing teeth, systemic diseases, periodontitis or patients on analgesics (NSAIDs, and corticosteroids) were excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
A comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires.	2.6 years	In this randomized clinical trial, 44 patients were recruited who needed bilateral extractions of first premolars in upper arches. Patients were divided into two groups based on the timing of extractions. Group A needed extractions before alignment while Group B needed extractions for retraction of anterior teeth. Group A was sent for extractions first while Group B went for orthodontic bonding and banding procedures for orthodontic treatment. After series of aligning wires (0.014, 0.016, 17x25, 19x25 Heat activated NiTi and 19x25 SS) patients from group B were sent for extractions. For pain assessment, an 11-point numerical rating scale (NRS) were given to record pain intensity at 2, 4, 8, 12 and then 24 hours after extraction for the next 7 days.