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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)

U

Universiti Sains Malaysia

Status

Completed

Conditions

Orthodontic Treatment
Orthodontic Extraction
Orthodontic Treatment Via Premolar Extraction

Study type

Interventional

Funder types

Other

Identifiers

NCT06582836
BDC/R/101/19

Details and patient eligibility

About

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).

Enrollment

44 patients

Sex

All

Ages

14 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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