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Clinical Trials/CTRI/2023/07/055195
CTRI/2023/07/055195
Not yet recruiting
Not Applicable

3D-printed aligners as a state-of-the-art smile designing appliance for its integration in Indian public hospitals

Science and Engineering Research Board1 site in 1 country20 target enrollmentStarted: July 20, 2023Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Science and Engineering Research Board
Enrollment
20
Locations
1
Primary Endpoint
To compare the treatment outcome between direct 3D-printed aligners & conventional fixed orthodontic appliance as assessed by American Board of Orthodontics Discrepancy Index & Objective Grading system.

Overview

Brief Summary

This is a non-randomized prospective controlled clinical study comparing the effectiveness and duration of orthodontic treatment with direct 3D-printed clear aligners and traditional fixed labial orthodontic appliances in 20 patients with mild-to-moderate malocclusion. The primary outcome measure will be the assessment of treatment outcome using dental models, panoramic, and cephalometric radiographs. The secondary outcome will be the determination of time taken to complete the orthodontic treatment with the respective modality.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
10.00 Year(s) to 24.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients having mild to moderate malocclusion Patients having a complete set of permanent dentition Patients having no requirement of extraction Patients having no requirement of distallization Completion of treatment using clear aligners alone.

Exclusion Criteria

  • Patients having crowding or spacing more than 6mm Patients having severe antero-posterior/ transverse/ vertical skeletal dysplasia Patients having severely rotated of teeth Patients with multiple edentulous spaces, root stumps Patients with compromised periodontium and poor oral hygiene Patients with centric relation and centric occlusion discrepancies Patients with prosthetic dental implants Patients with retained deciduous teeth.

Outcomes

Primary Outcomes

To compare the treatment outcome between direct 3D-printed aligners & conventional fixed orthodontic appliance as assessed by American Board of Orthodontics Discrepancy Index & Objective Grading system.

Time Frame: Pre-treatment | Post-treatment

Secondary Outcomes

  • To determine the amount of time taken for the completion of treatment (duration) to compare the relative efficiency of the 3D printed aligners & conventional fixed orthodontic appliances(Pre-treatment)

Investigators

Sponsor
Science and Engineering Research Board
Sponsor Class
Government funding agency

Study Sites (1)

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