Effectiveness of Aligners Versus Rapid Maxillary Expansion

University of Turin

Status: Completed

Conditions: Maxillary Transverse Deficiency (MTD)

Treatments: Device: Tooth-borne Hyrax-type maxillary expander; Device: Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04760535

Maxillary Expansion

Details and patient eligibility

About

Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.

Full description

Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology. This two-arm parallel-group randomized prospective clinical trial will include patients with: indications for maxillary expansion treatment, age between 6 and 10 years old, mixed dentition, good standard of oral hygiene, good compliance during treatment as assessed by the practitioner. Patients will be assigned to one of two expansion methods (arm A: Invisalign® First clear aligners, arm B: tooth-borne Hyrax-type maxillary expander) according to a computer-generated randomization list shortly before the start of expansion Primary outcome measure will be the change in palatal morphology (palatal volume and surface area variations). Secondary outcomes will be: arch dimensions (upper inter-canine width, upper inter-molar width, anterior segment length, posterior segment length), complications, patients' satisfaction and periodontal health. Due to the nature of the intervention blinding will not be possible. Potential statistical differences between the two intervention groups will be evaluated.

Enrollment: 40 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who have been diagnosed with transverse maxillary deficiency;
• mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
• fully erupted upper and lower first molars;
• transversal discrepancy ≤5mm
• demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
• subjects willing to consent to the trial and comply with the trial regime.

Exclusion criteria

• any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
• permanent teeth extraction-based treatment (third molars excluded);
• morphologic crown anomalies;
• auxiliary treatment during arch expansion stage (such as crossbite elastics);
• posterior interproximal reduction;
• orthognathic surgery treatment planned;
• cleft palate or severe facial deformities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Arm A: Invisalign® First clear aligners

Experimental group

Description:

The Invisalign® First aligners are fabricated in a multilayer aromatic thermoplastic polyurethane/co-polyester 0.75mm (.030")-thick with a fine 3D manufacturing process.

Treatment:

Device: Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)

Arm B: tooth-borne Hyrax-type maxillary expander

Active Comparator group

Description:

The Hyrax-type maxillary expander is a tooth-borne expansion appliance that is fixed to the upper second deciduous molars (or to the first permanent molars) using bands and includes a midline 12-mm self-locking screw (Forestadent, Pforzheim, Germany; 0.9 mm, complete turn). The expansion screw is connected to the conventional molar bands or printed clasps, modeled surrounding the molars, via a framework of 0.9mm stainless-steel wire. The framework is soldered to the bands and extending on the palatal side to the deciduous canines. The expander will be fabricated by qualified laboratory technician.

Treatment:

Device: Tooth-borne Hyrax-type maxillary expander