NCT04760535

Effectiveness of Aligners Versus Rapid Maxillary Expansion

Effectiveness of Aligners Versus Rapid Maxillary Expansion on 3D Palatal Volume in Mixed Dentition Patients: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-10-15
• Completion: 2021-05-03
• First posted: 2021-02-18
• Last updated: 2022-05-25

Locations

1 site across 1 country: Italy