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)

NCT06582836 | Completed

• 1 other identifier: BDC/R/101/19
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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. 1.Does extracting teeth before starting orthodontic treatment result in different pain levels compared to extracting teeth after alignment?
2. 2.How do pain levels change over time after the extractions in each group?

Conditions

Orthodontic Extraction; Orthodontic Treatment; Orthodontic Treatment Via Premolar Extraction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

investigate the effect of prior engagement of tooth with orthodontic appliance on post extraction pa

EXPERIMENTAL

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.

Behavioral: The objective of the study was to investigate the effect of prior engagement of tooth with orthodontic appliance on post extraction pain among orthodontic patients

Interventions

The objective of the study was to investigate the effect of prior engagement of tooth with orthodontic appliance on post extraction pain among orthodontic patients BEHAVIORAL

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.

investigate the effect of prior engagement of tooth with orthodontic appliance on post extraction pa

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Baqai Medical University

Karachi, Sindh, 300043, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: June 10, 2019
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

PA (1)