A clinical trial to study the efficiency of limited bone injury in increasing the rate of tooth movement during orthodontic treatment.

Phase 2

Completed

• Conditions: Dental malocclusion, forwardly placed upper front teeth.; Proclined upper incisors.

• Registration Number: CTRI/2017/08/009331
• Lead Sponsor: Dr Shivani Singh

Brief Summary

This study is an in vivo, interventional, surgical, single-center, split-mouth randomized, controlled clinical trial evaluating the efficiency of micro-osteoperforations in enhancing the rate of canine retraction and its effects on various dental and bony structures.

The primary outcome measure will be the mean rate of canine retraction per month, which will be measured intraorally.

The hypotheses are:

1. There is no difference in the rate of micro-osteoperforation assisted and conventional canine retraction.

2. There is no difference in the amount of anchorage loss, cumulative canine displacement, root resorption, alveolar bone loss, bone density and discomfort level between micro-osteoperforation and conventional canine retraction.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-07
• Study Completion: 2018-10-13
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients undergoing fixed mechanotherapy with upper first premolar extractions requiring 5 mm or more of maxillary canine retraction.
• Presence of full complement of teeth except third molars.
• Fair oral hygiene.

Exclusion Criteria

• Patients presenting with: 1.
• Previous history of orthodontic treatment.
• Medical or systemic problems.
• Active caries, pulpitis or periodontal disease.
• Severe crowding (≥6mm) or severe cant of the maxillary skeletal base or palatal plane (inclination angle ≤ 80 and ≥ 95 degrees and base plane angle ≤20 and ≥40 degrees) simultaneously existing with severely divergent or convergent facial planes (Bjork sum <385 and >400).
• Patients exhibiting microdontia or less than 5 mm of space available for canine retraction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean rate of canine retraction per month, until 2 mm or less space is present distal to canine. Measured intraorally using a digital calipers. Measured as: residual extraction space between lateral incisor (disto-gingival wing of the bracket) and canine (mesio-gingival wing of the bracket); in mm; then expressed as [(space T0-space T1)/time T0-to-T1] in mm/month. Measured by: a calibrated person, fully blinded to experimental/control side (an orthodontist).	Measurement timing: at baseline (before space closure), at 1-month intervals; end at space closure finalization (2 mm or less space remaining distal to the canine).

Secondary Outcome Measures

Name	Time	Method
•Cumulative canine distal movement measured in mm, on pre and post dental casts.	• Canine and molar rotation, tip, root resorption,bone density in HU, and alveolar bone loss to be measured on CBCT scans.

Trial Locations

Locations (1)

Manipal College of Dental Sciences.; 🇮🇳 Kannada, KARNATAKA, India

Manipal College of Dental Sciences.

🇮🇳Kannada, KARNATAKA, India

Dr Shivani Singh

Principal investigator

8880984538

emailshivanisingh@gmail.com