Effectiveness of Aligners Versus Rapid Maxillary Expansion

• ClinicalTrials.gov Identifier: NCT04760535
• Recruitment Status: Recruiting
• First Posted: February 18, 2021
• Last Update Posted: February 18, 2021
• Sponsor: University of Turin, Italy
• Information provided by (Responsible Party): Tommaso Castroflorio, University of Turin, Italy

Study Description

Brief Summary:

We aim 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. In this two-arm parallel-group randomized prospective clinical trial we 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.

Condition or disease	Intervention/treatment	Phase
Maxillary Transverse Deficiency (MTD)	Device: Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA); Device: Tooth-borne Hyrax-type maxillary expander	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Aligners Versus Rapid Maxillary Expansion on 3D Palatal Volume in Mixed Dentition Patients: a Randomized Controlled Trial
• Actual Study Start Date: January 15, 2019
• Actual Primary Completion Date: March 15, 2020
• Estimated Study Completion Date: July 15, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: 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.	Device: Tooth-borne Hyrax-type maxillary expander; The expansion protocol will be one quarter-turn twice a week (0.45 mm activation per week) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander will be left passively for retention for a minimum of 6 months.

Outcome Measures

Primary Outcome Measures :

1. Palate morphology [ Time Frame: 12 months ]
   The primary outcome will be to evaluate the changes in palatal morphology after the treatment of maxillary deficiencies using two different therapies and to re-evaluate changes over the initial 12-months after the end of the treatment. The changes in palatal morphology are defined as the variation in palatal volume and surface. These will be measured from digitized study models within the boundaries of the palate, the gingival and distal planes, defined as follow. The gingival plane will be created by connecting the midpoints of the dentogingival junction of all upper erupted deciduous and permanent teeth. The distal plane will be created through two points at the distal of the first upper permanent molars perpendicular to the gingival plane.

Secondary Outcome Measures :

1. Upper arch dimensions [ Time Frame: 12 months ]
   Changes in upper arch transverse dimensions (Upper inter-canine width (ICW), Upper inter-molar width (IMW), Anterior segment length (ASL), Posterior segment length (PSL)) will be also recorded.
2. Appliances survival [ Time Frame: 12 months ]
   Appliances survival (secondary outcome measure) will be recorded as the time to the first episode of failure. The date of failure will be recorded as the day the patient became aware of the problem or the date the clinician will note the failure when participants will be unaware of a failed retainer.
3. Patient satisfaction [ Time Frame: 12 months ]
   Patient satisfaction (secondary outcome measure) will be determined by a modified 10-cm visual analogue scale (VAS)26, which contained 10 questions. Patients were given oral and written instructions and explanations on how to complete these questionnaires. The lowest (least favourable) score was '0' and the highest (most favourable) score was '10' For example if the retainer was very uncomfortable, it was scored as '0' and if it was very comfortable, it was scored as '10'. The questionnaires will be administered to the participants and filled in front of the treating doctor at their scheduled review appointments. The data from the questionnaires were coded and will be assessed by one investigator.
4. Periodontal health [ Time Frame: 12 months ]

   Periodontal measurements will be taken in the maxilla by a calibrated operator before, at the end of the active orthodontic treatment and at the subsequent review appointments.

   A simplified Basic Periodontal Examination (BPE) on three index teeth will be performed in all co-operative children and adolescents included in the trial. The simplified BPE is performed using the WHO 621 probe with a light probing force of 20-25 g.

   It is recommended the use of a simplified examination determining only codes 0, 1, 2 up to the age of 11 years because of the likelihood of pseudopockets associated with newly erupting teeth.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• patients who have been diagnosed with transverse maxillary deficiency;
• age between 6 and 10 years old;
• mixed dentition with first molars fully erupted;
• 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.

Contacts and Locations

Locations

Italy

University of Turin; Recruiting

Turin, Italy, 10126

Contact: Tommaso Castroflorio, DDS +393383003907 tommaso.castroflorio@gmail.com

Sponsors and Collaborators

University of Turin, Italy

More Information

• Responsible Party: Tommaso Castroflorio, DDS, Ortho spec, PhD, University of Turin, Italy
• ClinicalTrials.gov Identifier: NCT04760535
• Other Study ID Numbers: Maxillary Expansion
• First Posted: February 18, 2021
• Last Update Posted: February 18, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No