Clear Orthodontic Expander Versus Hyrax (COE-Hyarx)

University of Baghdad

Status: Not yet enrolling

Conditions: Narrow Maxilla; Malocclusion

Treatments: Device: New clear expander; Device: Hyrax expander

Study type: Interventional

Funder types: Other

Identifiers

NCT07362160

1158

1158425

Details and patient eligibility

About

This study will be conducted to evaluate the effectiveness of a clear expander fabricated from 2-mm biocompatible polyethylene terephthalate glycol (PETG) thermoforming material integrated with an expansion screw in achieving dental and skeletal expansion in adolescent patients, compared with the conventional Hyrax expander.

Full description

This will be a multicenter randomize clinical trial with two-arm parallel groups, and will be conducted at the Department of Orthodontics, College of Dentistry, University of Baghdad, as well as different specialized dental centers affiliated with the Iraqi Ministry of Health, and some private clinics.

The sample size will be calculated based on previous studies with similar aim to measure the skeletal expansion. A minimum sample size of 17 patients was required, and in order to account for a 15% dropout, a total of 20 patients will be recruited for each group (new clear expander and hyrax expander). The amount of 2.5 mm or greater of maxillary sutural opening will be considered clinically effective.

Two randomizations will be employed, one for the expander type and the other for the cleaning method of the new expander, a computer random generator will be used to develop a simple randomization with an equal allocation ratio (1:1) and without stratification.

Data Collection and Measurements will be include, CBCT evaluation, Intraoral scan of the maxillary arch evaluation, overjet and overbite, CBCT-derived cephalometric images will be used to measure the maxillary mandibular plane angle, Microbial evaluation after using two different methods for cleaning the new clear expander and at the end of the treatment, the patient will be asked to fill out a questionnaire about the treatment, giving information about their experience and satisfaction during treatment.

Data will be analyzed using the Statistical Package for Social Sciences for Windows, version 26.0, including Descriptive Statistics 9numbers, frequencies, percentages, mean, median, and standard deviations), Reliability Statistics (an intraclass correlation coefficient), and Inferential Statistics (Levene's test, Shapiro Wilk test, Paired samples t-test and Independent samples t-test).

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients' age at the start of treatment will range from 10-14 years.
2. Unstable unilateral or bilateral posterior crossbite due to maxillary constriction.
3. The first molars are fully erupted.
4. Good oral health free from caries and periodontal problems at the start of treatment.
5. Good general health.

Exclusion criteria

1. Patients with a vertical growth pattern.
2. Patients with obvious facial asymmetry.
3. Patients with orofacial cleft.
4. Patients with previous orthodontic treatment.
5. Patients with bad oral habits.
6. Patients with active periodontal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

New clear expander

Experimental group

Description:

After obtaining the 3D-printed maxillary dental cast, a 2 mm PETG (rigid) thermoforming material (Leone® S.p.A., Florence, Italy) will be adapted separately to the maxillary cast using a pressure molding vacuum machine. The clear appliance will then be trimmed and finished. Depending on the degree of maxillary constriction, a Leone® Standard or universal expansion screw (Leone® S.p.A.,Florence, Italy) measuring 6-9 mm will be incorporated into the appliance and positioned in the midline of the maxillary cast after splitting the appliance midpalatally embedded in acrylic composed from Methyl methacrylate monomer and Methyl methacrylate polymer Orthocryl® liquid (monomer), and Orthocryl® EQ-powder (polymer) (Dentaurum GmbH \& Co. KG, Ispringen, Germany)

Treatment:

Device: New clear expander

Hyrax expander

Experimental group

Description:

After obtaining the 3D-printed maxillary dental cast, patients will be treated with a Hyrax expander using a rapid expander from Leone® S.p.A., Florence, Italy, cemented in the upper first premolars and first molars. If the first premolars had not yet erupted, the Hyrax expander will be cemented in the upper first permanent molars only.

Treatment:

Device: Hyrax expander