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Идёт набор NCT07069218

Hydroxyapatite Toothpastes and Enamel Remineralization:

Без фазы С лечением Enamel Hypomineralization Tooth Erosion

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: Biorepair® Total Protection Plus Toothpaste, Bioniq® Toothpaste.
Кому может быть актуально
Состояния в реестре: Enamel Hypomineralization, Tooth Erosion. Базовые параметры: 6 лет — 18 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial

Обзор

This randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. The study compares Biorepair® Total Protection Plus, which contains biomimetic microRepair particles, with Bioniq® Repair, a conventional hydroxyapatite-based toothpaste. Forty participants will be randomly assigned to either the trial group (Biorepair®) or the control group (Bioniq®), and both groups will receive quarterly professional dental cleanings and use the assigned toothpaste twice daily for 6 months. The primary outcome is the change in enamel demineralization, assessed by DIAGNOdent Pen scores, in permanent molar fissures and upper central incisors. Secondary outcomes include enamel integrity assessed by DIAGNOcam imaging and ICDAS scores, as well as changes in dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation (Plaque Index), gingival inflammation (Bleeding Index), and extrinsic stains (Modified Lobene Stain Index). Patient satisfaction will also be evaluated at the end of the study using a self-administered questionnaire. This study will help determine whether biomimetic hydroxyapatite offers superior benefits in maintaining enamel health compared to conventional formulations, supporting evidence-based preventive strategies in dental care.

Вмешательства

  • Препарат Biorepair® Total Protection Plus Toothpaste
    Participants will use Biorepair® Total Protection Plus toothpaste twice daily for 6 months. The toothpaste contains biomimetic microRepair® particles based on zinc-substituted hydroxyapatite, intended to promote enamel remineralization, reduce sensitivity, and protect against erosion and plaque accumulation. Professional dental cleanings will also be performed every 3 months.
  • Препарат Bioniq® Toothpaste
    Participants will use Bioniq® Repair toothpaste twice daily for 6 months. The toothpaste contains 20% conventional hydroxyapatite and is designed to restore enamel, reduce dentin hypersensitivity, and protect against erosion. Professional dental cleanings will also be performed every 3 months.

Первичные конечные точки

  • Change in DIAGNOdent Pen values in enamel fissures and upper central incisors [Срок оценки: Baseline to 6 months (T0-T3)]
Вторичные конечные точки (7)
  • Change in ICDAS Scores via DIAGNOcam Imaging [Срок оценки: Baseline to 6 months (T0-T3)]
  • Change in Dentin Hypersensitivity Using Schiff Air Index [Срок оценки: Baseline to 6 months (T0-T3)]
  • Change in Enamel Erosion Using BEWE Index [Срок оценки: Baseline to 6 months (T0-T3)]
  • Change in Plaque Accumulation Using Plaque Index [Срок оценки: Baseline to 6 months (T0-T3)]
  • Change in Gingival Inflammation Using Bleeding Index [Срок оценки: Baseline to 6 months (T0-T3)]
  • Change in Extrinsic Staining Using Modified Lobene Stain Index [Срок оценки: Baseline to 6 months (T0-T3)]
  • Patient Satisfaction via Self-Administered Questionnaire [Срок оценки: At 6 months (T3 only)]

Критерии участия

Критерии включения

  • Subjects aged between 6 and 18 years
  • Ability to understand and follow instructions in Italian or English
  • Signed written informed consent provided by the parent/legal guardian and assent from the minor
  • Good cooperation and adherence to clinical instructions
  • Fully erupted permanent first molars and upper central incisors in good general condition
  • DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range

Критерии исключения

  • DIAGNOdent Pen values greater than 25
  • Ongoing systemic antibiotic therapy
  • Presence of sealants or composite restorations on first permanent molars or upper central incisors
  • Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white/brown spot lesions
  • Poor motivation or limited compliance with study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Идентификаторы

NCT: NCT07069218 · 2025-REMINEN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗