Идёт набор NCT07362160

Clear Orthodontic Expander Versus Hyrax

Без фазы С лечением Malocclusion Narrow Maxilla

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: New clear expander, Hyrax expander.
Кому может быть актуально: Состояния в реестре: Malocclusion, Narrow Maxilla. Базовые параметры: 10 лет — 14 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Ирак
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

Устройство 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 cus
Устройство 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.

Первичные конечные точки

CBCT evaluation [Срок оценки: pre-treatment (T0) and immediately post-treatment (T1) around one to two months]

Вторичные конечные точки (5)

Intraoral scan of the maxillary arch evaluation [Срок оценки: pre-treatment (T0) and post-treatment (T1) around one to two months]
Clinical evaluation [Срок оценки: pre-treatment (T0) and immediately post-treatment (T1) around one to two months]
Cephalometric analysis [Срок оценки: pre-treatment (T0) and immediately post-treatment (T1) around one to two months]
Microbial evaluation [Срок оценки: after one month.]
Patient satisfaction with the appliance [Срок оценки: around one to two months]

Критерии участия

Критерии включения

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