Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding
November 30, 2017 updated by: Omar Abdelaziz, Cairo University
Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding: A Randomized Clinical Trial
The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray.
Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients seeking orthodontic treatment with fixed orthodontic appliance.
- Patients with full set of permanent teeth
- Good oral hygiene and periodontal condition.
Exclusion Criteria:
- Patients suffering from any periodontal disease.
- Patients with poor oral hygiene
- Enamel hypoplasia and hypocalcification
- Deep carious lesions / large restorations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 3D printed transfer tray group
Indirect bonding using digital 3D printed transfer tray
|
Indirect bonding of orthodontic attachments using digital 3D printed transfer tray
Intraoral Scanning of the bonded brackets
superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy
|
|
ACTIVE_COMPARATOR: Thermoformed transfer tray group
Indirect bonding using Thermoformed transfer tray
|
Intraoral Scanning of the bonded brackets
superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy
Indirect bonding of orthodontic attachments using thermoformed transfer tray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Linear and angular Positioning of the brackets
Time Frame: Immediately after bonding
|
To evaluate the transfer accuracy of the brackets by the two transfer trays by measuring the linear and angular differences in the brackets' positions before and after bonding.
|
Immediately after bonding
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bonding failure of the brackets.
Time Frame: three months
|
Evaluation of the bond failure by counting the number of detached brackets immediately and over a three months follow up period.
|
three months
|
|
Chair side time
Time Frame: during the bonding procedure
|
To evaluate the chair side time of indirect bonding in each technique
|
during the bonding procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2017
Primary Completion (ANTICIPATED)
December 1, 2018
Study Completion (ANTICIPATED)
March 1, 2019
Study Registration Dates
First Submitted
November 26, 2017
First Submitted That Met QC Criteria
November 30, 2017
First Posted (ACTUAL)
December 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 6, 2017
Last Update Submitted That Met QC Criteria
November 30, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CEBC-CU-2017-11-28
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.