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临床试验/NCT06585436
NCT06585436已完成不适用

Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments: An in Vivo Study

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
post operative pain

研究概览

简要总结

The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.

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
Double (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

  • Patients with first and second molars with occlusal deep carious lesions (Class I) extending to the inner third of dentin thickness on radiographic examination using (i-sensor H1, Woodpecker, China).
  • Teeth with a healthy response to the electrical pulp tester (DY 310, Denjoy Dental CO., LTD, China).
  • Teeth with the absence of spontaneous pain.
  • Teeth with a negative sensitivity to percussion.
  • Teeth with the absence of periapical lesions by a digital radiographic examination.
  • Clinically, all teeth were without any mobility.
  • Patients who will complete the procedure of follow up.
  • Patients who will sign the consent.

排除标准

  • Mutilated teeth or teeth with caries extending subgingivally.
  • Teeth with the existence of previous restorations.
  • Teeth with periodontal disease, any swelling, fistulas, signs of irreversible pulpitis or necrotic pulp.
  • Teeth with roots showing external or internal resorption.
  • Pregnant women.
  • Presence of any systemic disease.

结局指标

主要结局

post operative pain

时间窗: 18 months

evaluation of the post operative pain following restorations using modified USPHS

次要结局

未报告次要终点

研究者

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

Mohamed Ahmed Abdallah Rabiea

teaching assistant

Al-Azhar University

研究点 (2)

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