Набор по приглашению NCT07136155

Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars.

Без фазы С лечением Dental Caries

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: Hall Technique, Indirect pulp capping.
Кому может быть актуально: Состояния в реестре: Dental Caries. Базовые параметры: 4 лет — 9 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: Иордания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars: A Randomized Controlled Trial.

Обзор

This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.

Подробное описание

Children aged 4-9 years old presenting with occlusal or proximal carious lesions of primary molars radiographically extending into the inner third or quarter of dentin will be invited to participate in this study. Patients will be randomized into two treatment groups using online block randomization technique (block of 6) and sealed envelope techniques. Time taken for clinical procedure will be recorded by a research assistant prospectively from the time the child sits on the dental chair till the end of procedure. Child pain perception will be recorded during intervention by a blinded research assistant using the Sound Eye Motor scale (SEM). Parental preference and child acceptance for each procedure will be recorded immediately after treatment using parent and child questionnaires. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.

Вмешательства

Процедура Hall Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Процедура Indirect pulp capping
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).

Первичные конечные точки

Patient pain perception [Срок оценки: Perioperatively]
Rate of Radiographic Success [Срок оценки: 6,12 months]
Child acceptance of treatment [Срок оценки: immediately following intervention]
Parent acceptance of treatment [Срок оценки: immediately following intervention]
Rate of Clinical Success [Срок оценки: 3,6,12 months]

Вторичные конечные точки (1)

Time taken for intervention [Срок оценки: Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.]

Критерии участия

Критерии включения

Fit and healthy.
Occlusal or proximal carious lesions on primary molars radiographically extending into the inner third or quarter of dentin.
Vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
No tenderness to percussion, or pathological mobility.
No radiographic evidence of interradicular/ periapical radiolucency.
Radiographic evidence of a radiopaque dentin layer between the radiolucent caries lesion and the dental pulp
Tooth is restorable.
Patient has good level of cooperation for the intended procedure.
Parents consented for their children to be included in the study.