A clinical try to compare the changes in the tooth and bone position when using a new type of braces using very light forces and a conventional braces used for treating patients with irregular teeth-A 3 Dimensional study.

Phase 3

Not yet recruiting

• Conditions: Persons encountering health services for examinations,

• Registration Number: CTRI/2020/05/025028
• Lead Sponsor: Ormco Asia

Brief Summary

This is a randomized single blinded controlled study which aims to evaluate and compare the effects of a passive self ligating appliance vs conventional fixed appliance wit broad and regular arch form when used to correct malocclusions.

A total of 80 randomly selected orthodontic patients with malocclusions of crowding oF more than 5mm in an arch  will be enrolled in this study. They will be divided into 4 groups of 20 patients  each.

Group 1-Control group using conventional brackets with regular arch forms.

Group 2-Passive self ligating brackets with broad arch forms.

Group 3-Passive self ligating with regular arch forms.

Group 4-Conventional brackets with broad arch forms.



All the patients are subjected to orthodontic diagnostic aids comprising of a Cone Beam Cone Beam Computed  tomography(CBCT) and Digital Models.

Patients were recalled for treatment according to specific group protocols and the arch wire changes were made.

At the completion of treatment the patients were  subjected to another set of CBCT and Digital models .The outcome parameters of bone thickness and arch dimensions were then compared to check and compare the effectiveness of each group.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-04-27
• Study Start: 2020-07-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Non Extraction Orthodontic treatment with a space discrepancy more than 5mm.
• Permanent dentition with full compliment of teeth excluding third molars.
• No relevant medical history.Â.

Exclusion Criteria

• Mixed dentition.
• Previous history of orthodontic treatment.
• Tooth with developmental anomalies and fluorosis.
• Restoration involving labial surface of tooth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alveolar Bone thickness	18 months

Secondary Outcome Measures

Name	Time	Method
Arch length and Arch width	19 months

Trial Locations

Locations (1)

Saveetha Dental College and Hospital; 🇮🇳 Thiruvallur, TAMIL NADU, India

Saveetha Dental College and Hospital

🇮🇳Thiruvallur, TAMIL NADU, India

Dr Harish Babu

Principal investigator

9360575950

harish.ortho@gmail.com