Precision Orthodontics: Virtual Treatment Planning for Orthodontic Braces

NCT04002999 | Unknown FDA Device

• 1 other identifier: 18-0615
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Malocclusion, Angle's Class

Keywords

3D printing; Virtual treatment planning

Outcome Measures

Primary Outcomes (1)

• Quality of first stage of orthodontic finish: Objective Grading System (OGS)

  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

  12months

Study Arms (3)

Ceramic braces, directly placed

ACTIVE COMPARATOR

Patients in this group will be treated with directly-bonded traditional tooth-colored ceramic brackets

Device: Stock bracket, no tray

Ceramic braces, indirectly placed

EXPERIMENTAL

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

3D printed customized ceramic braces

EXPERIMENTAL

Patients will be treated using indirectly bonded 3D-printed ceramic (tooth-closed) brackets

Device: 3D printed ceramic bracket and tray

Interventions

3D printed ceramic bracket and tray DEVICE

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.

3D printed customized ceramic braces

Stock ceramic bracket + 3D printed tray DEVICE

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

Ceramic braces, indirectly placed

Stock bracket, no tray DEVICE

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

Ceramic braces, directly placed

Eligibility Criteria

• Age: 11 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Dental Medicine: lead

Study Sites (1)

Harvard Dental Center

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Dean of Research

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: August 30, 2019
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: February 12, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)