NCT07362160

Clear Orthodontic Expander Versus Hyrax

Evaluating the Clinical Performance of a Novel Clear Orthodontic Expander Versus Hyrax: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Malocclusion
• Narrow Maxilla

Interventions

Type	Name	Description
DEVICE	New clear expander	All patients with a clear expander will be instructed to wear the appliance 24 hours a day, except during eating and cleaning. The expander will be activated twice daily (0.2 mm per turn). Patients will be provided with an instruction brochure and advised to use a reminder to ensure compliance. The expansion will continue until the desired amount of the maxillary arch expansion occurs when the maxillary first molars' palatal cusps occlude the lingual side of the mandibular first molar buccal cusps to overcome the expected relapse due to the elasticity of the palatal soft tissue.
DEVICE	Hyrax expander	The activation protocol for the Hyrax expander will be the same in all patients, twice daily (0.2 mm per turn). The expansion will continue until the desired amount of the maxillary arch expansion occurs when the maxillary first molars' palatal cusps occlude the lingual side of the mandibular first molar buccal cusps to overcome the expected relapse due to the elasticity of the palatal soft tissue.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-11-01
• Completion: 2027-02-01
• First posted: 2026-01-23
• Last updated: 2026-02-19

Locations

1 site across 1 country: Iraq