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Upper Sequential Distalization With TADs and Aligners

NCT ID: NCT04875104

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2023-12-31

Brief Summary

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In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition. The investigators are going to study if the movements that they predict are achieved and in which proportion and compare it between four different aligner systems. The investigators hypothesis is that there are no differences in the predictability of this movement between the four aligner systems.

Detailed Description

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In this study the investigators are going to assess and compare the predictability of distal movement of upper molars in patients with class II molar relationship when superimposing the initial malocclusion with the real end of distalization phase and the predicted end of distalization phase. Also, the investigators are going to study another dental movements, pain level, aligner properties, oral hygiene, posterior root resorption, patient satisfaction, quality of life and efficiency of these systems.

The aligner systems that are going to be used are Invisalign System (Align Technology, San José, CA), Spark Aligners (Ormco, Glendora, CA), Quicksmile (Madrid, España) and ClearCorrect (Straumann, Austin, TX). To help achieve the molar movement there is going to be place a TAD (temporary anchorage device) between two teeth. Before starting the study, the patients will need some pretreatment records (radiographs, photographs, dental casts and intraoral scan) to make a diagnosis and confirm if the patient is suitable for the study.

The required sample will be 98 subjects, assuming a sample loss of 15% the required sample will be 115 subjects per group. Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study. Data normality will be examined with the Kolmogorov-Smirnov. Descriptive statistics of the different outcomes will be calculated for each group. Student's paired sample t-test will be used to analyze intragroup differences between T0 and T1. Intergroup comparison among different intervention groups will be performed using multiple analysis of variance (MANOVA), with Tukey's post-hoc test. The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age. The investigators will perform a binary logistic regression in order to assess the influence of confounding factor (clinical variables) on the primary outcome. All statistical analysis will be conducted using IBM SPSS 24.0 (SPSS Inc., Chicago, IL, USA) software with a 0.05 level of significance.

Conditions

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Malocclusion, Angle Class II Distalization

Keywords

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Dentistry Orthodontics Clear aligner therapy Aligners Invisalign Upper molar distalization Temporary anchorage devices Mini-screws

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a 4-arm parallel-group, randomized, prospective superiority clinical trial with an allocation ratio of 1:1:1:1 There will be four groups of aligners of different brands.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Patients recruited into the study who met the inclusion criteria will be assigned to group 1 Invisalign, group 2 Spark, group 3 Quicksmile or group 4 ClearCorrect. To generate the allocation sequence, a block randomization system with block sizes of 4 and a 1:1:1:1 allocation ratio will be applied using GraphPad online software. The allocation will be concealed from the orthodontist, investigator, and patient. When a patient was determined to be eligible, the orthodontist explained the clinical trial to them, and the patient signed the informed consent to participate. After the allocation of the interventions, neither the patient nor the orthodontist will be blinded.

Study Groups

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Invisalign

Patients treated with Invisalign aligners

Group Type ACTIVE_COMPARATOR

Orthodontic treatment with Invisalign system

Intervention Type DEVICE

Patients are going to receive an orthodontic treatment with Invisalign aligners.

Spark

Patients treated with Spark aligners

Group Type EXPERIMENTAL

Orthodontic treatment with Spark system

Intervention Type DEVICE

Patients are going to receive an orthodontic treatment with Spark aligners.

Quicksmile

Patients treated with Quicksmile aligners

Group Type EXPERIMENTAL

Orthodontic treatment with Quicksmile system

Intervention Type DEVICE

Patients are going to receive an orthodontic treatment with Quicksmile aligners.

ClearCorrect

Patients treated with ClearCorrect aligners

Group Type EXPERIMENTAL

Orthodontic treatment with ClearCorrect system

Intervention Type DEVICE

Patients are going to receive an orthodontic treatment with ClearCorrect aligners.

Interventions

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Orthodontic treatment with Invisalign system

Patients are going to receive an orthodontic treatment with Invisalign aligners.

Intervention Type DEVICE

Orthodontic treatment with Spark system

Patients are going to receive an orthodontic treatment with Spark aligners.

Intervention Type DEVICE

Orthodontic treatment with Quicksmile system

Patients are going to receive an orthodontic treatment with Quicksmile aligners.

Intervention Type DEVICE

Orthodontic treatment with ClearCorrect system

Patients are going to receive an orthodontic treatment with ClearCorrect aligners.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who needed orthodontic treatment with aligners in both jaws.
* Adult patients (\>18 years)
* Full permanent dentition (excluding third molars)
* Patients with non-surgical or non-extraction (excluding third molars) treatment
* No active periodontal disease
* Patients with class II molar relationship that needed molar distalization

Exclusion Criteria

* Patients with systemic diseases affecting bone metabolism or teeth or inflammatory diseases
* Patients undergoing treatment with immunosuppressant or bisphosphonates
* Patients undergoing chemo and radiotherapy
* Patients with any other syndrome-associated orofacial deformation, cleft lip or palate
* Pregnant women or non(or poor)-compliance patients with skeletal discrepancies
* Patients with dental or skeletal crossbite that need 3 mm or more per side of expansion
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Iglesias Linares

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

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Universidad Complutense de Madrid

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carmen García Marín, Phd student

Role: CONTACT

Phone: 913941979

Email: [email protected]

Alejandro Iglesias Linares, FullProf

Role: CONTACT

Phone: 913941972

Email: [email protected]

Facility Contacts

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Carmen García Marín, phd student

Role: primary

Other Identifiers

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URI 39-150221

Identifier Type: -

Identifier Source: org_study_id