Time of Treatment in HALL Technique Vs ART

Официальное название

Time of Treatment of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: a Randomized Clinical Trial

Обзор

The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are: * Does the Hall Technique provide a faster and pain-free treatment compared to ART? * How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue. Participants will: * Receive treatment using either the Hall Technique or ART in a single session. * Attend follow-up visits to monitor the effectiveness and acceptance of the treatment. * Complete assessments on their experience and comfort during and after the procedure.

Вмешательства

• Процедура Atraumatic Restorative Treatment
  A sharp excavator will be used to remove soft demineralized carious tissue from the patient\'s primary molar 2-The molar will then be restored with capsulated Glass Ionomer in accordance to ART procedure. 3-Each capsule will be mixed for ten seconds and used for restoring teeth isolated by cotton rolls. 4-After the cement is cured, excess material will be removed with an excavator and a carver. 5-The occlusion will be tested for interferences with carbon paper. A layer of varnish coat wil
• Процедура Hall technique
  The procedure involves assessing the occlusion, contact points, and tooth shape. If contact points are present, orthodontic separators will be placed between the primary molars to create space for crown fitting, with the child seated upright to maintain airway safety. After 3 to 5 days, the separators will be removed, and loose plaque and debris will be cleared. The correct crown size will be selected, ensuring it doesn't impinge on adjacent teeth, and will be filled with glass ionomer cement.

Первичные конечные точки

• time of treatment [Срок оценки: during the procedure]

Вторичные конечные точки (4)

• Postoperative Pain and discomfort [Срок оценки: immediately after the procedure , 3month ,6 month and 12 month]
• Child behavior [Срок оценки: during the procedure]
• Canine overbite: HT [Срок оценки: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month]
• Child anxiety [Срок оценки: during the procedure]

Критерии участия

Критерии включения

• Age: From 4 to 6 years.
• Caries in primary molars within enamel/dentin with vital pulp.
• Healthy children.
• Cooperative children

Критерии исключения

• Presence of signs and symptoms of necrosis.
• Root caries.
• History of spontaneous pain.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06594770 · Hall technique VS ART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗