RecruitingNot Applicable

Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement

Spain114 participantsStarted 2024-10-22

Plain-language summary

The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.

Who can participate

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: * Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment * Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries. * No history of previous orthodontic treatment. * Complete permanent dentition (excluding third molars, their presence or absence being irrelevant). Exclusion Criteria: * Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs). * Pregnant women.

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

Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.

Timeframe: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries.

Timeframe: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

Trial details

NCT IDNCT06516185

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Alejandro Piñeda-Zayas

+34626923397 apined01@ucm.es

View on ClinicalTrials.gov More Crowding, Tooth trials

Who can participate

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.

What they're measuring

Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.

Timeframe: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries.

Timeframe: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.