A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

Официальное название

Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial

Обзор

This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.

Подробное описание

To evaluate the clinical performance of a newly developed self-etch primer (M-SEP) versus P-SEP in bonding metallic orthodontic brackets to different teeth, verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.

Objectives:

Primary; Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.

Secondary;

1. Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy. 2. Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography. 3. Measuring the total time required for remnant adhesive removal post bracket failure/debonding. 4. Evaluating patient perception during bracket failure/debonding and subsequent adhesive removal procedure.

Вмешательства

• Устройство Remineralizing self-etch primer (M-SEP, SEP 1)
  Experimental self-etch primer based on Transbond Plus modified with 7% nano-hydroxyapatite. Applied to labial/buccal enamel of incisors, canines, and premolars after pumice prophylaxis; air-dried 3 s, brackets bonded with Transbond XT and LED light-cured 10 s mesial and 10 s distal.
• Устройство Standard self-etch primer (P-SEP, SEP 2)
  Conventional Transbond Plus self-etch primer used according to manufacturer's instructions for enamel conditioning of incisors, canines, and premolars, followed by Transbond XT adhesive and LED light-curing as above.

Первичные конечные точки

• Bracket Bond Failure Rate [Срок оценки: 6 MONTH]

Вторичные конечные точки (1)

• Adhesive Remnant Index [Срок оценки: 6 MONTH]

Критерии участия

Критерии включения

• Full permanent dentition including incisors, canines, premolars, and molars (excepting 3rd molars;
• Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide,
• No previous orthodontic treatment with fixed appliances.

Критерии исключения

• Participants unable to give informed consent,
• Had craniofacial anomalies,
• Require orthognathic surgery as part of their treatment,
• Had congenital enamel defects.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic — Baghdad

Публикации

• Erbe C, Hartmann L, Schmidtmann I, Ohlendorf D, Wehrbein H. A novel method quantifying caries following orthodontic treatment. Sci Rep. 2021 Nov 1;11(1):21347. doi: 10.1038/s41598-021-00561-7. PMID 34725354
• Garma NMH, Ibrahim AI. Development of a remineralizing calcium phosphate nanoparticle-containing self-etching system for orthodontic bonding. Clin Oral Investig. 2023 Apr;27(4):1483-1497. doi: 10.1007/s00784-022-04767-5. Epub 2022 Nov 2. PMID 36322155

Идентификаторы

NCT: NCT07291830 · 1102425

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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