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临床试验/CTRI/2018/08/015410
CTRI/2018/08/015410尚未招募2 期

Clinical efficacy of universal adhesive for the restoration of non carious cervical lesion:A Randomized clinical trial

Vokkaligara Sangha Dental College and hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Marginal staining

研究概览

简要总结

Purpose: The objective of this double-blind randomized clinical trial was to evaluate the one year clinical performance of a new universal adhesive in noncarious cervical lesions (NCCLs) using the US Public Health Service (USPHS) evaluation criteria

Methods and Materials: A total of 100 restorations will be randomly placed in  patients according to the following groups: SE-et = selective enamel etching; and SET = self-etch. The composite resin will be placed and the restorations will be evaluated after one week (baseline) and at six months using and one year USPHS criteria to check the postoperative sensitivity fracture and marginal staining in non carious cervical lesions.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Patient requiring restoratons in the cervical region in a minimum of two sides and one tooth in each side
  • Cervical lesions with a depth of 1-3mm and width of 2-4mm
  • Patients willing to participate and sign the informed consent form
  • Subjects who have natural dentition directly opposing the test restoration.
  • •Patients having good oral hygiene.

排除标准

  • 1.ndividual with a chronic systemic disease with or without oral manifestations.
  • Individual with periodontal problems.
  • Subjects with known allergy to any materials used
  • Individual with bruxism and other parafunctional habits.

结局指标

主要结局

Marginal staining

时间窗: 7 days | 6months | 1 year

Sensitivity

时间窗: 7 days | 6months | 1 year

Fracture

时间窗: 7 days | 6months | 1 year

次要结局

  • Marginal staining(Sensitivity)

研究者

发起方
Vokkaligara Sangha Dental College and hospital
申办方类型
Private medical college

研究点 (1)

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