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临床试验/NCT06348953
NCT06348953已完成不适用

Outcome of Bioactive Versus Non-Bioactive System for Restoration of Deep Carious Molars Using Selective Caries Removal Technique: 18 Months Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5

研究概览

简要总结

This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context.

详细描述

Deep carious lesions in permanent molars present a significant challenge in restorative dentistry. Traditional approaches to caries removal often involve the removal of excessive healthy tooth structure, leading to weakened teeth and potential pulp exposure. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue, offering a conservative alternative to traditional methods. In recent years, bioactive restorative materials have emerged as promising alternatives to conventional non-bioactive materials. Bioactive materials are designed to interact with the biological environment, promoting remineralization and potentially enhancing the longevity of restorations. However, limited evidence exists comparing the efficacy of bioactive and non-bioactive restorative systems in deep carious lesions treated with selective caries removal. This study is designed as a prospective, randomized controlled trial. Patients presenting with deep carious lesions in permanent molars will be randomly allocated to receive either a bioactive or non-bioactive restorative system following selective caries removal. Baseline demographic and clinical data will be recorded for each participant. Clinical evaluations will be conducted at regular intervals over a follow-up period of months. Outcome measures will include restoration integrity (e.g retention, marginal adaptation), pulpal response (e.g., sensitivity, vitality).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • young adult patients (age: 18-40 years) of both genders.
  • Able to tolerate necessary restorative procedures.
  • Willing to sign the informed consent.
  • Accepts the follow-up period.
  • Posterior permanent tooth with occlusal proximal deep carious lesion.
  • Radiographically (bitewing radiograph) extending to the inner 1/3 of dentine (D3) with a radiopaque layer between the carious lesion and the pulp chamber.
  • Sensible teeth according to cold pulp test.

排除标准

  • Allergy to any restorative materials.
  • Patients undergoing orthodontic treatment with fixed appliances.
  • Pregnant women.
  • Patients with debilitating systemic diseases
  • Teeth with previous restorations.
  • Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
  • Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Cervical carious lesions.

研究组 & 干预措施

Conventional non-bioactive restorative system (Comparator)

Active Comparator

deep carious molars restored with conventional resin based restorative system

干预措施: selective caries removal and conventional non-bioactive restorative system (Other)

Bioactive system (Intervention)

Active Comparator

deep carious molars restored with bioactive resin based restorative system

干预措施: selective caries removal and bioactive restorative system (Other)

结局指标

主要结局

Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5

时间窗: 18 months

1. excellent(No hypersensitivity,normal vitality 2. good(Minor hypersensitivity for a limited time,normal vitality 3. satisfactory(Moderate hypersensitivity-Delayed/mild sensitivity;no subjective complaints,no treatment needed 4. unsatisfactory(Intense hypersensitivity-Delayed with minor subjective symptoms-No detectable sensitivity-Intervention necessary but not replacement 5. poor(Intense, acute pulpitis or non-vital tooth-Endodontic treatment is necessary and restoration replacement

次要结局

  • Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)(18 months)
  • Success or Failure(18 months)
  • continue Functional properties (Radiographic Examination -when applicable)(18 months)
  • Functional properties - (fracture and retention)(18 months)
  • Functional properties - Approximal anatomical form (contact point and contour)(18 months)
  • continue Functional properties ( marginal adaptation )(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mahmoud Ahmed Mohammed

General practitioner

Cairo University

研究点 (1)

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