Recruiting

Observational Study

Sponsor:

Harvard School of Dental Medicine

Code:

NCT04002999

Conditions

Malocclusion

Malocclusion, Angle's Class

Eligibility Criteria

Sex: All

Age: 11 - 65

Healthy Volunteers: Accepted

Interventions

3D printed ceramic bracket and tray

Stock ceramic bracket + 3D printed tray

Stock bracket, no tray

Study Details

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

Study ID

NCT04002999

Start date

Aug 30, 2019

Status verified date

Apr, 2019

Completion date

May, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ceramic braces, directly placed

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

experimental: Ceramic braces, indirectly placed

Patients will be treated with the same brackets from treatment group 1 but using the indirect bonding technique

experimental: 3D printed customized ceramic braces

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

Interventions

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.

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

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

Primary outcome measure

  • Quality of first stage of orthodontic finish: Objective Grading System (OGS) [ Time Frame: 12months ]

Central Contacts and Locations

Locations

Harvard Dental Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Bunmi Tokede, BDS

617-432-1434oluwabunmi_tokede@hsdm.harvard.edu

More Information

Sponsor

Harvard School of Dental Medicine

Last update posted

Feb 12, 2020

Last verified

Apr, 2019

Keywords

  • 3D printing
  • Virtual treatment planning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard School of Dental Medicine on 2020-02-12.