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Набор скоро начнётся NCT06573463

Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers

Без фазы С лечением Premature Tooth Exfoliation

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: Prefabricated band and loop, Conventional Band and loop.
Кому может быть актуально
Состояния в реестре: Premature Tooth Exfoliation. Базовые параметры: 4 лет — 6 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
Египет
Следующий шаг
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Официальное название

Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars

Обзор

To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars. A Randomized Clinical Trial

Подробное описание

When considering gingival health and cement dissolution, does the longevity of the prefabricated band and loop differ from the conventional band and loop constructed following the premature loss of the lower first primary molars?

The concept of preserving space after premature tooth loss has been recognized for over a century. Conventional appliances are used successfully as space maintainers, but some disadvantages like the need for at least two visits to deliver the appliance due to laboratory work, will definitely affect its role during the general anesthesia.

The prefabricated space maintainer requires only one visit as it is fitted into the patient's mouth at the clinic without needing the dental lab. This provides a good impact on apprehensive children as it reduces the number of visits and chairside time. Prefabricated space maintainers could be a new alternative to the conventional fixed space maintainers used in pediatric dentistry.

Вмешательства

  • Устройство Prefabricated band and loop
    Prefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes.
  • Устройство Conventional Band and loop
    Conventional band and loop is the most widely used space maintainer, It shows high success rate and good patient compliance, but needs more than one visit due to the laboratory work.

Первичные конечные точки

  • Gingival Health [Срок оценки: 3 month and 9 month]
  • Cement integrity [Срок оценки: 3 month and 9 month]
Вторичные конечные точки (2)
  • Space loss between the abutment teeth. [Срок оценки: 0 month and 9 month]
  • Change in arch dimension: [Срок оценки: 0 month and 9 month]

Критерии участия

Критерии включения

  • Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
  • Caries free, or restored mandibular second primary molars and deciduous canines on the side of the extraction maintained throughout the entire follow-up period.
  • Children are classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
  • According to space analysis, available space is less than or equal to the needed space
  • 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars
  • Children are mentally capable of communication.
  • Children aged 4-6 years

Критерии исключения

  • Children with any parafunctional habits.
  • Children with previous allergies to stainless steel.
  • Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
  • Parental refusal of participation.

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
Профилактика

Центры проведения

Египет · 1 центр
  • Cairo university — Cairo

Публикации

  • Kamki H, Kalaskar R, Balasubramanian S, Badhe H, Kalaskar A. Clinical Effectiveness of Fiber-reinforced Composite Space Maintainer and Band and Loop Space Maintainer in a Pediatric Patient: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S82-S93. doi: 10.5005/jp-journals-10005-2044. PMID 35082473
  • Tahririan D, Safaripour M, Eshghi A, Bonyadian AH. Comparison of the longevity of prefabricated and conventional band and loops in children's primary teeth. Dent Res J (Isfahan). 2019 Nov 12;16(6):428-434. eCollection 2019 Nov-Dec. PMID 31803390
  • Padma Kumari B, Retnakumari N. Loss of space and changes in the dental arch after premature loss of the lower primary molar: a longitudinal study. J Indian Soc Pedod Prev Dent. 2006 Jun;24(2):90-6. doi: 10.4103/0970-4388.26023. PMID 16823234
  • Thakur B, Bhardwaj A, Luke AM, Wahjuningrum DA. Effectiveness of traditional band and loop space maintainer vs 3D-printed space maintainer following the loss of primary teeth: a randomized clinical trial. Sci Rep. 2024 Jun 18;14(1):14081. doi: 10.1038/s41598-024-61743-7. PMID 38890410
  • Zhao J, Jin H, Li X, Qin X. Dental arch spatial changes after premature loss of first primary molars: a systematic review and meta-analysis of split-mouth studies. BMC Oral Health. 2023 Jun 28;23(1):430. doi: 10.1186/s12903-023-03111-x. PMID 37380944

Идентификаторы

NCT: NCT06573463 · Conventional vs prefabricated

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗