INDIRECT BONDING ACCURACY OF TWO DIFFERENT 3D PRINTED DIGITAL TRANSFER TRAYS: A RANDOMIZED CLINICAL TRIAL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Marmara University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Accuracy of bracket position
Study Overview
Brief Summary
The goal of this study is to compare the bracket transfer accuracy of two frequently used 3D printed indirect bonding trays.
This is an interventional study. Participants have 3-6mm crowding without tooth loss and deformity. It is planned to be 2 groups in the study. Each group will include 15 participants. Indirect bonding will be applied with shell and bar designs that are frequently used. Brackets will be bonded from second premolar to other side's second premolar of upper and lower jaw. Bracket transfer accuracy of two different trays will be compared with planned position and each other.
Detailed Description
There are planned to be 2 groups in the study. Each group will include 15 participants. The patients who apply for orthodontic treatment will be included in this study. inclusion criteria: patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health. The exclusion criteria were patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth. Informed and written consent forms will be obtained from each patient for experimentation.
Intraoral scans with the 3Shape device (3Shape TRIOS, Copenhagen, Denmark) are routinely recorded from the patients whose treatment will begin before treatment. Bracket positions will be adjusted on the scan images using 3Shape OrthoAnalyzer 2015 software. Then, the bracket model will be transferred to the Appliance Designer software program, 2 types of transfer trays will be designed and produced with the 3D printer in the clinic. Patients will be indirectly bracketed with the produced transfer trays and intraoral scan recordings will be taken again after bracketing. This image and the images where the brackets are placed in the software will be overlaid with the GOM Inspect software (GOM GmbH, Braunschweig, Germany) and the deviations will be calculated for both transfer trays and the differences will be compared.
The measurements to be performed are: linear: mesiodistal, buccolingual, incisogingival; angular: torque, angulation, rotation. Measurements will be calculated separately for all teeth.
None of these steps deviate from the routine treatment protocol and none of the procedures are harmful or invasive for the patient.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 17 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health.
Exclusion Criteria
- •Patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth.
Outcomes
Primary Outcomes
Accuracy of bracket position
Time Frame: 15 days
Angular (torque, tip, angulation) and linear (mesiodistal, buccolingual, occlusogingival) differences will be compared between the bonded intraoral scans taken immediately after IDB and the virtually bracketed model prepared in the Ortho Analyzer software (3Shape A/S, Copenhagen, Denmark) using the open source GOM inspect software (GOM GmbH, Braunschweig, Germany).
Secondary Outcomes
No secondary outcomes reported