UnknownNot Applicable

Precision Orthodontics: Virtual Treatment Planning for Orthodontic Braces

United States51 participantsStarted 2019-08-30

Plain-language 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.

Who can participate

Age range

11 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12months

Trial details

NCT IDNCT04002999

SponsorHarvard School of Dental Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

Contact for this trial

Dean of Research

View on ClinicalTrials.gov More Malocclusion trials