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Набор по приглашению NCT06731465

Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment

Без фазы С лечением Crowding of Anterior Mandibular Teeth

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: Clear aligner therapy, Fixed pre-adjusted edgewise orthodontic appliance.
Кому может быть актуально
Состояния в реестре: Crowding of Anterior Mandibular Teeth. Базовые параметры: 13 лет — 45 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
ОАЭ
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Efficiency, Efficacy, Periodontal and Occlusal Outcomes for Clear Aligners Versus Pre-adjusted Orthodontic Appliances in Moderately Crowded Lower Incisor Treatment: A Randomized Clinical

Обзор

The goal of this clinical trial is to compare between fixed labial braces and clear aligners for the straightening of moderately overlapped lower front teeth. The main questions it aims to answer are: * Effect of treatment on gum health * Which treatment achieves lower front teeth alignment faster in terms of alignment time and t number of visits required to the orthodontist * How well it straightens teeth. Participants will: * Receive either labial braces or clear aligners as part of their orthodontic treatment. * Come for regular follow-up visits every 4 to 6 weeks with the orthodontist till full straightening of the lower front teeth. * Have a 3D scan of their teeth taken after their teeth are aligned along with a specialized x-ray of their head and jaw.

Подробное описание

The study is a randomized controlled trial aimed at comparing the efficiency, efficacy, periodontal and occlusal outcomes between two orthodontic treatment options: clear aligners and traditional fixed braces for patients with moderate crowding in the lower incisors.

Pre-treatment diagnostic records including clinical examination, intraoral scans, intraoral and extraoral photographs will be obtained for each participant.

To ensure that participants in both groups have similar levels of crowding severity and comparable dental health characteristics at the start of the study, randomization will be conducted in blocks. A total of forty participants (20 in each group) will be selected according to specific criteria designed to maintain this uniformity across both treatment groups.This study follows a parallel-group design and the participants will be randomly allocated into one of the two groups included in the study:

Intervention Groups:

* Group A - Fixed Labial Braces (Master Series®, American Orthodontics): In the traditional braces group, fixed metal brackets will be bonded to the lower teeth, and archwires will be used in a specific sequence designed to bring the teeth into alignment over time. * Group B - Clear Aligners (EON Aligner): The clear aligner group will receive custom-fitted aligners created using a digital model of each participant's teeth. These aligners are removable, requiring patient adherence to wearing them for at least 22 hours daily.

Primary Outcomes:

1. Total alignment time 2. Clinical measures of periodontal status 3. Occlusal contact distribution 4. Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth

Secondary Outcomes:

1. Total number of scheduled routine appointments and additional emergency visits 2. Missed appointment rate 3. Number of refinements 4. Bracket/ attachment failure rate 5. Chair-side Time 6. Treatment Efficiency Index 7. BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score 8. Immunological Assay using ELISA 9. Patient's occlusal comfort level 10. Changes in mandibular incisor inclination 11. Changes in the mandibular arch form

Data will be analyzed using SPSS (Statistical Package for the Social Sciences) software, with statistical tests appropriate to the variable types (e.g., Mann-Whitney for group comparisons and Wilcoxon Signed-Rank test for time-related variables).

Вмешательства

  • Устройство Clear aligner therapy
    Participants in this group will receive clear aligners (EON Aligner, Minneapolis), designed and customized based on a digital model of each patient's dental structure. Aligners will be worn for at least 22 hours daily, and patients will change to a new aligner depending on treatment progress.
  • Устройство Fixed pre-adjusted edgewise orthodontic appliance
    Participants in this group will be treated with pre-adjusted fixed orthodontic appliances (Master Series®, American Orthodontics™, WI, USA). This system includes fixed brackets bonded on the labial surface of teeth and a sequence of progressively larger arch wires aimed at achieving alignment over time.

Первичные конечные точки

  • Total alignment time [Срок оценки: Through alignment, an average of 6 months]
  • Bleeding on probing [Срок оценки: Baseline, after 3 months, and after 6 months]
  • Occlusal contact surface area [Срок оценки: Baseline, and after an average of 6 months, and after treatment an average of 1 year]
  • Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth [Срок оценки: Baseline, and after an average of 6 months]
  • Symmetry of contact distribution [Срок оценки: Baseline, and after an average of 6 months]
  • Probing depth [Срок оценки: Baseline, after 3 months, and after 6 months]
  • Plaque index [Срок оценки: Baseline, after 3 months, and after 6 months]
  • Gingival index [Срок оценки: Baseline, after 3 months, and after 6 months]
  • Total treatment time [Срок оценки: Through treatment, an average of 1 year]
Вторичные конечные точки (11)
  • Total number of scheduled routine appointments and additional emergency visits [Срок оценки: Through alignment, an average of 6 months]
  • Missed appointment rate [Срок оценки: Through alignment, an average of 6 months]
  • Number of refinements [Срок оценки: Through alignment, an average of 6 months]
  • Bracket/ attachment failure rate [Срок оценки: Through alignment, an average of 6 months]
  • Chair side time [Срок оценки: Through alignment, an average of 6 months]
  • Treatment Efficiency Index [Срок оценки: Through alignment, an average of 6 months]
  • BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score [Срок оценки: Baseline, after 3 months, and after 6 months]
  • Immunological Assay using ELISA [Срок оценки: Baseline, after 3 months, and after 6 months]
  • Patient's occlusal comfort level [Срок оценки: Baseline, and after an average of 6 months, and after treatment an average of 1 year]
  • Changes in mandibular incisor inclination [Срок оценки: Baseline, and after an average of 6 months]
  • Changes in the mandibular arch form [Срок оценки: Baseline, and after an average of 6 months]

Критерии участия

Критерии включения

  • Patients with moderate lower crowding (Little's 4 to 6 mm), non-extraction treatment
  • Age range: 13-45 years old
  • Class I malocclusion
  • Full permanent dentition
  • No caries or periodontal disease

Критерии исключения

  • Extraction cases
  • Patients with craniofacial syndromes, or cleft palate
  • Patients with uncontrolled medical conditions or taking medication that can interfere with orthodontic tooth movement.
  • Presence of extensive dental restorations in proximity to the gingival margin
  • Presence of fixed bridges/crowns or partial dentures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

ОАЭ · 1 центр
  • University Dental Hospital Sharjah (UDHS_ — Sharjah city

Публикации

  • Buschang PH, Shaw SG, Ross M, Crosby D, Campbell PM. Comparative time efficiency of aligner therapy and conventional edgewise braces. Angle Orthod. 2014 May;84(3):391-6. doi: 10.2319/062113-466. Epub 2013 Nov 18. PMID 24749702

Идентификаторы

NCT: NCT06731465 · REC-23-05-13-01-PG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗