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Precision Orthodontics: Virtual Treatment Planning for Orthodontic Braces

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002999
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Harvard School of Dental Medicine

Brief Summary:

The investigators are evaluating the effectiveness of custom-made 3D-printed ceramic (tooth-colored) brackets (braces) compared to conventional tooth-colored brackets (braces).

Participants will be expected to come in for regularly scheduled appointments. They will be treated with tooth-colored braces and will need to come in every 4-6 weeks and will be randomly assigned to one of three groups. "Randomly" means by chance, like a coin toss. Neither participants nor the researchers may choose group assignments. Group 1 patients will have tooth-colored braces placed directly on each tooth by the clinician. Group 2 patients will have the braces placed on the teeth by using trays to fit them on. Group 3 patients will have customized 3D printed tooth-colored braces placed on their teeth, using trays to fit them on. If a participant is selected to be part of group 3, it may take up to two additional weeks for these 3D brackets to be printed and shipped and so this might delay treatment onset. Information on gender, age, and medical history of participants will also be obtained from the electronic health record.


Condition or disease Intervention/treatment Phase
Malocclusion Malocclusion, Angle's Class Device: 3D printed ceramic bracket and tray Device: Stock ceramic bracket + 3D printed tray Device: Stock bracket, no tray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Precision Orthodontics: Customized Versus Conventional Orthodontic Bracket Prescriptions - A Randomized Controlled Clinical Trial
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Active Comparator: Ceramic braces, directly placed
Patients in this group will be treated with directly-bonded traditional tooth-colored ceramic brackets
Device: Stock bracket, no tray
Direct bonding is the traditional way of placing orthodontic brackets, in which orthodontists clinically eyeball the tooth and place the bracket where they deem most appropriate

Experimental: Ceramic braces, indirectly placed
Patients will be treated with the same brackets from treatment group 1 but using the indirect bonding technique
Device: Stock ceramic bracket + 3D printed tray
Traditionally, indirect bonding, starts with creating a mold of all the teeth as an exact replica of the mouth of the patient. From there, in the lab, the orthodontist positions each bracket precisely where it should go on each tooth and then creates a custom tray that allows transfer of the brackets from the lab model to the patient's teeth. By taking the time to place the brackets in a proper position on the lab model, orthodontists eliminate the inaccurate process of placing orthodontic brackets directly on the teeth. It theoretically also takes less chairside time and is more comfortable for the patient. It is however more technique sensitive. In this study, indirect bonding setup will be done virtually using commonly-available orthodontic software. The trays/jigs will then be 3-D printed

Experimental: 3D printed customized ceramic braces
Patients will be treated using indirectly bonded 3D-printed ceramic (tooth-closed) brackets
Device: 3D printed ceramic bracket and tray
The 3D ceramic bracket being investigated is the only available customized ceramic bracket. This will be a first for the orthodontic speciality. This will also be the first and only customized bracket system that includes customization of the bracket base. This helps in the control of first order orthodontic movements and allows brackets to be bonded on any labial surface of the tooth while maintaining an ideal prescription. As 3D printing is not limited by the mold-ejection in CIM, [24] the bracket system being tested here has the potential to achieve a more accurate slot dimension.




Primary Outcome Measures :
  1. Quality of first stage of orthodontic finish: Objective Grading System (OGS) [ Time Frame: 12months ]
    A number of measures have been developed to determine the quality of orthodontic treatment. The Objective Grading System (OGS), [27] developed by the American Board of Orthodontics (ABO) in 1994, was designed to establish a uniform and objective evaluation of cases



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects over the age of 10 years and below 65;
  • Eruption of all permanent teeth excluding second and third molars;
  • Non-extraction treatment;
  • Maximum of 7mm of crowding/spacing;
  • No more than 45 degrees of rotations

Exclusion Criteria:

  • Presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars); congenitally missing teeth, and tumors of the parathyroid gland;
  • The presence of bridges or implants;
  • Significant (> moderate) periodontal disease, intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class), pregnancy; and
  • Cases requiring tooth extractions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002999


Contacts
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Contact: Dean of Research

Locations
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United States, Massachusetts
Harvard Dental Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Bunmi Tokede, BDS    617-432-1434    oluwabunmi_tokede@hsdm.harvard.edu   
Sponsors and Collaborators
Harvard School of Dental Medicine
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Responsible Party: Harvard School of Dental Medicine
ClinicalTrials.gov Identifier: NCT04002999    
Other Study ID Numbers: 18-0615
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Harvard School of Dental Medicine:
3D printing
Virtual treatment planning
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases