跳至主要内容
临床试验/CTRI/2019/08/020634
CTRI/2019/08/020634尚未招募2 期

Evaluation of adhesion strategies in restoration of Non Carious Cervical Lesions extending to root surface-a randomized controlled trial

R Praveen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月8日最近更新:
适应症

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
Comparison of Clinical performance between two universal adhesive agents using USPHS criteria

研究概览

简要总结

The aim of the study is to evaluate the clinical performances of two adhesive agents. The patients will be randomized to the following groups by simple randomization.GROUP 1:  Total Etch (Etch and rinse - 5th Generation), GROUP 2:  Universal Adhesive in Self Etch(8th Generation), GROUP 3: Universal Adhesive in Selective Enamel Etch(8th Generation), all the Restorative procedure will be carried out by a single operator. Adhesive protocol will be followed as per the randomization schedule. Restoration will be done using Nano Hybrid Composite. The patient and outcome assessor will be blinded to the study, making it a double-blinded randomized controlled trial. The patient will be evaluated by two independent calibrated examiners at time intervals of 1, 3, 6, 12 and 18 months using USPHS criteria.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • •Teeth with Non Carious Cervical Lesions extending to the root Depth of non carious cervical lesion should be more than 1 mm.

排除标准

  • •History of existing tooth hypersensitivity Bruxism Cervical Caries Non-vital teeth Known inability to return for recall Appointments Fractured or visible cracked teeth Medically compromised patients Allergy to components of resin-based materials Existing periodontal disease Third molar Sub gingival lesion.

结局指标

主要结局

Comparison of Clinical performance between two universal adhesive agents using USPHS criteria

时间窗: 1,3,6,12 and 18 months

次要结局

  • Pulpal and Periodontal Health at the end of follow up periods.(1,3,6,12 and 18 months)

研究者

发起方
R Praveen
申办方类型
Other [self funded, Meenakshi Ammal Dental College Allapakkam main road maduravoyal chennai 600095 ]

研究点 (1)

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