Набор скоро начнётся NCT07382245

Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children

Без фазы С лечением Early Childhood Caries (ECC) Active Dentin Caries in Primary Molars

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: Nano-Silver Fluoride, Silver Diamine Fluoride.
Кому может быть актуально: Состояния в реестре: Early Childhood Caries (ECC), Active Dentin Caries in Primary Molars. Базовые параметры: 3 лет — 5 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: 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

Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children: A Randomized Clinical Trial

Обзор

Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration. This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.

Подробное описание

This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group.

Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires.

The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.

Вмешательства

Препарат Nano-Silver Fluoride
Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
Препарат Silver Diamine Fluoride
38% Silver Diamine Fluoride

Первичные конечные точки

Caries arrest of active dentin caries [Срок оценки: 1, 3, 6, 9 and 12 months]

Вторичные конечные точки (3)

Discoloration of carious lesions [Срок оценки: 1, 3, 6, 9 and 12 months]
Post-operative pain [Срок оценки: 1, 3, 6, 9 and 12 months]
Parental satisfaction [Срок оценки: 1, 3, 6, 9 and 12 months]

Критерии участия

Критерии включения

Apparently healthy children.
Children with age ranged from 3-5 years from both genders.
Children who refused dental treatment with Frankl Behavior Rating Scale 1 and 2.
Children having molars with active dentin caries score (2,3,4) according to International Caries Detection and Assessment System- ICDAS II, detected by visual and tactile.
Parents/guardians accept treatment and write informed consent.