Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System

Официальное название

Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System : A Randomized Clinical Trial

Обзор

This study is a multi-center, prospective, parallel-group randomized controlled trial designed to compare the orthodontic treatment outcomes of a passive self-ligating bracket system (Damon Ultima) versus a clear aligner system. The primary objective is to evaluate and compare the total orthodontic treatment duration between the two systems in patients with Angle Class I malocclusion and moderate crowding. Secondary objectives include assessing alignment efficiency, patient pain perception at multiple time intervals, dental arch dimension changes, root volume loss percentage, and overall treatment quality using the American Board of Orthodontics Objective Grading System (ABO-OGS).

Подробное описание

Participants aged 17-32 years with full permanent dentition, Class I canine and molar relationships, and moderate crowding (4-8 mm) will be randomly assigned in a 1:1 ratio to either the Damon Ultima group or the Clear Aligner group.

For the Damon Ultima group, brackets will be bonded according to a standardized protocol, utilizing a precise archwire sequence from 0.014-inch CuNiTi up to 0.019x0.0275-inch stainless steel wires. For the Clear Aligner group, patients will be treated with a series of thermoformed removable aligners designed via digital software, with instructions to wear them for 22 hours per day, changing aligners every 2 weeks.

Outcome measurements will include total treatment duration in months, pain perception via a 10-cm Visual Analog Scale (VAS), dental arch changes on 3D digital models, and root resorption via Cone-Beam Computed Tomography (CBCT) radiographs.

Вмешательства

• Устройство self ligating bracket
  Teeth will be bonded with Damon Ultima® bracket system by the same protocol of bonding for all patients with the same bonding materials, time and curing apparatus by highly filled light-cure adhesive (Enlight, Ormco Corp., Glendora, California, USA). Archwire sequence will be: 0.014-inch CuNiTi, 0.018-inch CuNiTi, 0.014×0.0275-inch CuNiTi, 0.018×0.0275-inch CuNiTi archwires and 0.019×0.0275-inch stainless steel Ultima finishing archwires if needed. Appointment intervals will be 6-8 weeks for tr
• Устройство Clear aligner
  a series of invisible thermoformed removable aligners after designed by software and delivered to patients after the digital scanning of the initial models. A series of nearly invisible appliances to incrementally move the teeth from their crowded initial position to their final straightened position, these subjects will instructed to wear each aligner 22 hours a day, 7 days a week . The anterior teeth will be reduce at each interproximal location by means of diamond-coated finishing strips use

Первичные конечные точки

• Primary Objectives : Total Treatment Duration. [Срок оценки: From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).]

Вторичные конечные точки (5)

• Patient Pain Perception. [Срок оценки: "Baseline (Day 1), and at 6 hours, 24 hours, 3 days, and 7 days following the initial appliance insertion and after each subsequent archwire activation or aligner change throughout the active treatment phase, up to 14 months."]
• Dental Arch Alignment Efficiency [Срок оценки: Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.]
• Changes in Dental Arch Dimensions [Срок оценки: Baseline (Day 1) and through study completion, an average of 14 months]
• Root Volume Loss Percentage. [Срок оценки: Baseline (Day 1) and through study completion, an average of 14 months]
• Objective Grading System Score. [Срок оценки: Through study completion, an average of 14 months]

Критерии участия

Критерии включения

• Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
• Age range between 16-32 years.
• Presence of full permanent dentition except the third molars.
• Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
• Without previous orthodontic treatment/ functional appliances.

Критерии исключения

• Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
• Patient with class Ⅱ , Ⅲ malocclusion.
• Patient with external or internal root resorption.
• Patients with poor oral hygiene or active periodontal disease.
• 90o or more degree of tooth rotation.

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

Ирак · 1 центр

• University of Baghdad — Baghdad

Идентификаторы

NCT: NCT07638397 · 1193426

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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