Clinical trial NCT06516185: Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement
Official title: Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crowding, Tooth
Tipped Tooth or Teeth
Rotation of Tooth
Malocclusion, Angle's Class
Keywords: clear aligner therapy
direct-printed aligner
predictability
shape memory
stratification
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed following CONSORT guidelines as a randomized equivalence clinical trial, controlled, with two parallel arms, and single-blind.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
measure: PROMs of the patient undergoing direct-printed aligner treatment compared to the control group.
timeFrame: These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months.
measure: influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print.
timeFrame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Complutense University of Madrid
Study officials:
References: