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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Septodont
- 入组人数
- 275
- 试验地点
- 13
- 主要终点
- Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Temporary teeth treated in restorative treatment
For temporary teeth treated in restorative treatment arm, the following restoration indications will be found :
- In the crown
- Permanent dentine restoration (including under composites or Inlay/Onlay)
- Enamel restoration for up to 6 months
- Restoration of deep and/or large coronal carious lesions
- Restoration of cervical or radicular lesions
- On the pulp
- Direct pulp capping
- Indirect pulp capping
- Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes
干预措施: Dental restorative or endodontic treatment requiring Biodentine XP use (Device)
Permanent (mature or immature) teeth treated in restorative treatment.
For permanent (mature or immature) teeth treated in restorative treatment arm, the following restoration indications will be found :
- In the crown
- Permanent dentine restoration (including under composites or Inlay/Onlay)
- Temporary dentine-enamel restoration (for up to six-months)
- Restoration of deep and/or large coronal carious lesions
- Restoration of cervical or radicular lesions
- On the pulp
- Direct pulp capping
- Indirect pulp capping
- Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes
干预措施: Dental restorative or endodontic treatment requiring Biodentine XP use (Device)
Permanent (mature or immature teeth) treated in endodontic treatment.
For permanent (mature or immature) teeth treated in endodontic treatment arm, the following endodontic indications will be found :
For permanent teeth (immature or mature):
- Repair of root perforations
- Repair of furcation perforations
- Repair of perforating internal resorption
- Repair of external resorption
- Root-end filling in endodontic surgery (retrograde filling)
For immature permanent teeth with necrotic pulp:
- Apexification
- Revitalization procedure relying on root canal revascularisation.
干预措施: Dental restorative or endodontic treatment requiring Biodentine XP use (Device)
结局指标
主要结局
Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
时间窗: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.
Crown and pulp (restoration) Clinical: No pain, no pulpal symptomatology, no abscesses, no swelling, fistula. Positive response to the pulp vitality electric test. Radiographic : No radiolucency at the site of treatment \& no wideining of desmodontal space (permanent tooth), Root canal development (permanent immature teeth). Indications in the root (endodontic) except revitalization Clinical success: No pain, no inflammation, no abscesses, no swelling and/or fistula. Natural motion or mobility ≤ 1mm, Negative periodontal probing (≤ 4 mm) or positive periodontal probing (\> 4 mm) Radiographic success: Absence or reduction of radiolucency at the site of treatment. Indications in the root (endodontic) only for revitalization: Clinical success: No pain, no abscesses, no swelling and/or fistula, Mobility inferior or equal to the initial situation. Radiographic success: Absence or reduction of radiolucency at the site of treatment. Root canal development (for permanent immature teeth)
次要结局
- Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed(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)(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.(From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.)