- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07814716
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
Обзор исследования
Статус
Условия
Подробное описание
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Бразилия, 59056-000
- Рекрутинг
- Federal University of Rio Grande do Norte
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Контакт:
- Lavínia L. Costa, Master's
- Номер телефона: +55 84 998987405
- Электронная почта: lavinialourencocosta@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Children aged 5-10 years.
- Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
- Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Exclusion Criteria:
- Extensive carious lesion with subgingival margins.
- Clinical or radiographic signs of pulpal inflammation or necrosis.
- Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
- Previous restorative treatment of the eligible tooth.
- Presence of bruxism.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Bands
Participants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9).
A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron).
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Selective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement.
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Активный компаратор: Crowns
articipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal.
The crown will be cemented with glass ionomer luting cement (Meron).
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Placement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
The crown will be cemented with glass ionomer luting cement.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Marginal adaptation
Временное ограничение: 18 months after treatment
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Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement.
Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
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18 months after treatment
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Retention
Временное ограничение: 18 months after treatment
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Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement.
Alpha will be considered successful retention and Charlie a failure.
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18 months after treatment
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Presence of carious lesions
Временное ограничение: 18 months after treatment
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Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present.
Alpha will be considered clinically satisfactory and Charlie a failure.
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18 months after treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Biofilm accumulation
Временное ограничение: Immediately after treatment and at 6, 12, and 18 months
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Biofilm accumulation will be assessed using the Silness and Löe Plaque Index, ranging from 0 to 3: 0, absence of biofilm; 1, thin biofilm film along the free gingival margin; 2, moderate accumulation within the gingival sulcus; and 3, abundant accumulation within the gingival sulcus.
Lower scores indicate less biofilm accumulation.
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Immediately after treatment and at 6, 12, and 18 months
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Child-reported treatment acceptability
Временное ограничение: Immediately after treatment
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Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
The negatively worded item will be reverse-scored.
Higher total scores indicate greater treatment acceptability.
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Immediately after treatment
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Caregiver-reported treatment acceptability
Временное ограничение: Immediately after treatment
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Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
Higher total scores indicate greater treatment acceptability.
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Immediately after treatment
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
- Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.
- Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 8.054.527
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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