Effectiveness of Aligners Versus Rapid Maxillary Expansion

NCT ID: NCT04760535

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-05-03

Brief Summary

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.

Detailed 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.

Conditions

Maxillary Transverse Deficiency (MTD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm B: tooth-borne Hyrax-type maxillary expander

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.

Group Type: ACTIVE_COMPARATOR

Tooth-borne Hyrax-type maxillary expander

Intervention Type: DEVICE

The expansion protocol was one quarter-turn twice a day (0.45 mm activation per day) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander was left passively for retention for a minimum of 6 months. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.

Arm A: Invisalign® First clear aligners

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.

Interventions

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

Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.

Intervention Type: DEVICE

Tooth-borne Hyrax-type maxillary expander

The expansion protocol was one quarter-turn twice a day (0.45 mm activation per day) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander was left passively for retention for a minimum of 6 months. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Castroflorio

Aggregate Professor of Orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Turin

Turin, , Italy

Countries

Italy

References

Bruni A, Ferrillo M, Gallo V, Parrini S, Garino F, Castroflorio T, Deregibus A. Efficacy of clear aligners vs rapid palatal expanders on palatal volume and surface area in mixed dentition patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2024 Sep;166(3):203-214. doi: 10.1016/j.ajodo.2024.04.006. Epub 2024 Jul 26.

Reference Type: DERIVED

PMID: 39066746 (View on PubMed)

Other Identifiers

Maxillary Expansion

Identifier Type: -

Identifier Source: org_study_id