Digital vs. Conventional Indirect Bonding.

Официальное название

Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure

Обзор

This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques for fixed orthodontic bracket placement in adolescent patients requiring treatment in both dental arches. Each participant will receive both bonding techniques, with allocation of the digital and conventional indirect bonding procedures to the upper or lower arch determined by randomization. The study will evaluate the time required to complete bracket bonding procedures and the early clinical performance of the two techniques, assessed by bracket failure within the first month after appliance placement.

Подробное описание

Indirect bonding has been proposed as an alternative to direct bonding for the placement of orthodontic brackets, with potential advantages in terms of clinical efficiency, bracket positioning, and patient comfort. In recent years, computer-aided three-dimensional design and manufacturing methods have enabled the production of digital transfer trays for indirect bonding, offering a potentially more standardized workflow compared with conventional laboratory-based procedures.

This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques in patients undergoing fixed orthodontic treatment in both the upper and lower arches. Each participant will receive both techniques, with the allocation of the digital and conventional bonding procedures to the upper or lower arch determined by randomization.

In the digital indirect bonding procedure, transfer trays will be produced using a digital workflow and brackets will be bonded using a pre-coated adhesive system. In the conventional indirect bonding procedure, transfer trays will be produced using a standard laboratory workflow and brackets will be bonded using a conventional orthodontic adhesive system.

The study will assess the procedural efficiency of the two techniques by recording the time required to complete the bracket bonding procedure. Early clinical performance will be evaluated by recording bracket failures during the first month of orthodontic treatment. All procedures and follow-up assessments will be performed in a clinical orthodontic setting.

Вмешательства

• Устройство digital indirect bonding technique
  Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
• Устройство conventional indirect bonding technique
  Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique

Первичные конечные точки

• Time required to complete bracket bonding procedures, measured in minutes [Срок оценки: During procedure (from the beginning of bracket bonding to completion of bracket placement)]

Вторичные конечные точки (1)

• Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination [Срок оценки: 1 month after placement of the fixed orthodontic appliance]

Критерии участия

Критерии включения

• Patients aged 12 to 18 years requiring fixed orthodontic treatment on both upper and lower arches
• Presence of full permanent dentition, including erupted second molars

Критерии исключения

• Presence of dental anomalies in number (supernumerary or missing teeth) in either arch
• Orthodontic treatment plans involving tooth extractions in either arch
• Nickel allergy
• History of cleft lip and/or palate
• Craniofacial syndromes

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

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Orthodontic Clinic, Division of Dentistry, Careggi University Hospital — Florence

Идентификаторы

NCT: NCT07692880 · LF17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗