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)

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires.	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.	2.6 years

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BDC/R/101/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No