Upper Sequential Distalization With TADs and Aligners

NCT04875104 | Unknown FDA Device

• 1 other identifier: URI 39-150221
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion, Angle Class II; Distalization

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Predictability of upper molar distalization

  Predictability of upper molar distalization will be assessed in mm comparing pre- and post-distalization 3D models. Pre-treatment 3D model (ModT0) will be superimposed with ideal end of distalization model (ClinT1) and real end of distalization models to see how much distalization has been achieved. The predictability will be the difference between the achieved and the expected amount of tooth movement and to quantify distalization measurements are going to be made in various views and teeth.

  Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)

• Achievement of molar class I

  Achievement of class I after distalization will be assessed with yes (=1) or no (=0). It will be considered class I when the mesiobuccal cusp of the upper first molar occludes with the mesiobuccal groove of the lower first molar when seeing models in occlusion with a discrepancy of 0.5 mm.

  Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)

Secondary Outcomes (18)

• Individual tooth movement

  Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)

• Periodontal mucosa health status - Plaque Index (PI)

  Time 0 (initial day of treatment), month 3 and month 6

• Periodontal mucosa health status - Gingival Index (GI)

  Time 0 (initial day of treatment), month 3 and month 6

• Periodontal mucosa health status - Papillary Bleeding Index (PBI)

  Time 0 (initial day of treatment), month 3 and month 6

• Peri-implant mucosa inflammation

  Time 0 (initial day of treatment), month 3 and month 6

Study Arms (4)

Invisalign

ACTIVE COMPARATOR

Patients treated with Invisalign aligners

Device: Orthodontic treatment with Invisalign system

Spark

EXPERIMENTAL

Patients treated with Spark aligners

Device: Orthodontic treatment with Spark system

Quicksmile

EXPERIMENTAL

Patients treated with Quicksmile aligners

Device: Orthodontic treatment with Quicksmile system

ClearCorrect

EXPERIMENTAL

Patients treated with ClearCorrect aligners

Device: Orthodontic treatment with ClearCorrect system

Interventions

Orthodontic treatment with Invisalign system DEVICE

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

Invisalign

Orthodontic treatment with Spark system DEVICE

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

Spark

Orthodontic treatment with Quicksmile system DEVICE

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

Quicksmile

Orthodontic treatment with ClearCorrect system DEVICE

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

ClearCorrect

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Alejandro Iglesias Linares

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Carmen García Marín, Phd student

CONTACT

913941979; carmeg06@ucm.es

Alejandro Iglesias Linares, FullProf

CONTACT

913941972; aleigl01@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 6, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-04

Locations

ES (1)