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临床试验/NCT05465369
NCT05465369招募中不适用

Clinical Assessment Of Injectable Flowable Composite With Giomer Based Technology Versus High Viscosity Glass Ionomer Restorations in Atraumatic Restorative Treatment (ART) For Cancer Patients (One Year Randomized Clinical Trial)

Cairo University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
2
主要终点
recurrence of caries

研究概览

简要总结

Aim of the Study:

This study will compare between injectable flowable composite (Beautifil flow plus x) and high viscosity glass ionomer (Equia Fil) by ART caries preventive protocol in high caries risk patients receiving chemotherapy and/or radiotherapy

详细描述

Statement of the problem:

Chemotherapy and radiation therapy may cause changes in the lining of the mouth and the salivary glands. This can upset the healthy balance of bacteria. These changes may lead to mouth sores, infections, and tooth decay.

Rationale:

Patients under chemotherapy treatment and radiotherapy are systemically compromised and undergo hospital manipulations and residency, increasing their caries risk, fear, and anxiety. That's why they need specific caries preventive protocols designed for high-risk patients. Atraumatic restorative treatment (ART) is recommended for these patients to decrease pain and anxiety.

Atraumatic restorative treatment (ART) and interim therapeutic restoration (ITR) have had increased interest in the past few years. ART and ITR are comparative approaches and are performed utilizing the same material, but they contrast within the reason of their utilize. ART is very effective as a restorative technique since it is more conservative than conventional treatment. Also in this technique, we avoid using rotary equipment and dental anaesthesia, which increase anxiety during the dental procedure. ITR, on the other hand, is used as a temporary restoration that will be replaced with a more definitive one.

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
Single (Participant)

入排标准

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

入选标准

  • existing caries in permanent posterior teeth
  • Permanent posterior teeth with active carious lesion class I and class II without any signs and symptoms of pulp disease.
  • Teeth in normal occlusion
  • Absence of any active periodontal disease.

排除标准

  • Patients whose systemic involvement was too advanced to allow dental manipulation, such as those who were admitted to the intensive care unit
  • Patients with parafunctional habits
  • Presence of any sign or symptoms of irreversible Pulpitis or necrotic pulp
  • Partially erupted teeth

结局指标

主要结局

recurrence of caries

时间窗: 12 months

Modified USPHS criteria

次要结局

  • Restoration clinical performance(12 months)

研究者

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

Mennatallah Ahmed Shawkey

Master's degree student ,faculty of dentistry

Cairo University

研究点 (2)

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