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Clinical Trials/CTRI/2024/10/075567
CTRI/2024/10/075567CompletedPhase 4

Evaluation and comparison of the rate of orthodontic tooth movement in patients undergoing en-masse retraction with and without Low-Intensity Pulsed Ultrasound (LIPUS) Application: A prospective clinical study

Government College of Dentistry Indore1 site in 1 country30 target enrollmentStarted: November 2, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
The rate of orthodontic tooth movement in en-masse anterior teeth retraction with and without LIPUS application in both maxillary and mandibular arches.

Study Overview

Brief Summary

The study is a clinical trial to evaluate and compare the rate of orthodontic tooth movement in patients undergoing en-masse retraction with and without Low-Intensity Pulsed Ultrasound (LIPUS) application.

The patients requiring all first bicuspid extraction are to be included. Retraction is to be performed using NiTi closed coil springs attached from hooks between canine and lateral incisors to hooks on molars.

The amount of space closure is to be recorded every month by measuring the space remaining between canine and second bicuspid in all four quadrants.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
16.00 Year(s) to 25.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with Class I malocclusion with bimaxillary protrusion.
  • Average growth pattern of the jaws.
  • Patients within the age range of 16-25 years.
  • Patients with rationally advised extraction of first premolars for orthodontic treatment.
  • Patients with fully erupted permanent dentition.
  • Patients with good oral and general health.

Exclusion Criteria

  • Patients with pregnancy, systemic disease, or syndromes.
  • Medication interfering with tooth movement.
  • Skeletal discrepancy in any of the three planes.
  • Extracted, missing, or badly decayed permanent teeth (not including 3rd molars).
  • History of orthodontic treatment.

Outcomes

Primary Outcomes

The rate of orthodontic tooth movement in en-masse anterior teeth retraction with and without LIPUS application in both maxillary and mandibular arches.

Time Frame: T0 - Beginning of retraction | T1 - 3 months after beginning of retraction | T2 - Completion of retraction

Secondary Outcomes

  • N/A(N/A)

Investigators

Sponsor
Government College of Dentistry Indore
Sponsor Class
Other [Government Dental College]
Responsible Party
Principal Investigator
Principal Investigator

Dr Oshin Sharma

GOVERNMENT COLLEGE OF DENTISTRY, INDORE

Study Sites (1)

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