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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)

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06582836
Enrollment
44
Registered
2024-09-03
Start date
2019-06-10
Completion date
2021-12-10
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Extraction, Orthodontic Treatment, Orthodontic Treatment Via Premolar Extraction

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).

Interventions

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

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.

Sponsors

Universiti Sains Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
A comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires.2.6 yearsIn 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026