Идёт набор NCT06955429

Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

— Наблюдательное Dental Restoration, Permanent Dental Restorations Endodontic Treatment

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: Dental restorative or endodontic treatment requiring Biodentine XP use.
Кому может быть актуально: Состояния в реестре: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment. Базовые параметры: от 2 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: Бельгия, Франция
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

Observational, Prospective, International and Multicenter Clinical Investigation Measuring the Longterm Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

Обзор

The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.

Подробное описание

This clinical investigation is done according to the European Medical Device Regulation (MDR) 2017/745 and is considered as an observational, post-market clinical follow-up study with no additional invasive and cumbersome procedures. Biodentine™ XP has been marketed in the US since 2022 and was launched in Europe in May 2023.

The aim of the study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in its coronal restorative and endodontic dental indications.

The investigators participating in the clinical investigation will be general dental surgeron practitioners, with a great experience in restorative and endodontic indications or in pediatric dentistry, also users of Biodentine™.

This Clinical Investigation is an Observational, Prospective, and Multicenter study. This clinical investigation will take place in several investigational centres in France and Belgium.

This Clinical InvestigatioI is a prospective study: Patients will be treated with the study device (according to its CE-marked Instruction For Use), then followed up.

Вмешательства

Устройство Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.

Первичные конечные точки

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed [Срок оценки: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.]

Вторичные конечные точки (3)

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed [Срок оценки: 6 months,1 year for temporary teeth; 6 months, 1 year, 2 years and 5 years for permanent (mature or immature) teeth.]
Dentin bridge formation presence (only in restorative indications) [Срок оценки: At 6 months, 1 year, 2 years post treatment with Biodentine™ XP for temporary teeth (based on X-ray done if required). At 6 months, 1 year, 2 years, 5 years and 10 years post-treatment for permanent (mature or immature teeth)]
Safety parameters of Biodentine™ XP during the whole duration of the study including the incidence of treatment-emergent adverse events and device deficiencies. [Срок оценки: From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.]

Критерии участия

Критерии включения

Temporary tooth, from a child ≥ 2 years old, requiring dental restorative treatment with Biodentine™ XP, and/or, Permanent (mature or immature) tooth, from a child or an adult, requiring a dental restorative and/or an endodontic treatment with Biodentine™ XP.
Adult patient with a signed informed consent form; For the minor, if in age to understand, an assent is required, and at least one parent or legal representative must consent.
Only in France: Subject affiliated or benefiting from a social/health insurance system.

Критерии исключения

Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
Inadequate expected tooth lifetime as estimated by the investigator:

For a Temporary tooth: high probability of tooth loss within 2 years after treatment with Biodentine™ XP.
For a permanent tooth: high probability of tooth loss within 10 years after treatment with Biodentine™ XP.
Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
Adult patient under legal protection measures or unable to express his/her consent, and individual deprived of liberty by judicial or administrative decision, as well as individual receiving psychiatric care.
Periodontitis (stage 3, 4 or stage 2 grade C).
Inability to comply with study procedures.
Participation in another interventional clinical investigation that can induce bias in the study results.

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

Здоровые добровольцы: Нет