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临床试验/CTRI/2019/06/019949
CTRI/2019/06/019949已完成4 期

Comparative Evaluation of Post Operative Sensitivity in Non Carious Cervical Lesions restored with Giomer and Nanoceramic composite Resin- An In Vivo Study

Dr Surbhi Gupta1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月7日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Patients will be evaluated for presence or absence of post operative sensitivity after the defined recall period.

研究概览

简要总结

This study is a randomized controlled clinical trial which will evaluate post operative sensitivity in Non Carious Cervical Lesions restored with Giomer using self etch adhesive and Nanoceramic composite resin using universal adhesive system with self etch and selective enamel etch mode. Mandibular premolars with non carious cervical lesions indicated for restorations will be selected according to the predefined inclusion and exclusion criteria. Sample size of 120 teeth will be selected for the study.They will be divided into 2 main groups A and B and then each group into 2 subgroups.Cavity preparation and restoration will be done. Patients will be kept on a recall period of 24 hours ,1 month,3 months and 6 months. Absence or presence of post operative sensitivity after the defined recall period will serve as the primary outcome of the study whereas intensity of post operative sensitivity will serve as the secondary outcome.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
35.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients with at least 24 natural teeth 2.Patients having at least 2 contralateral teeth with non carious cervical lesions indicated for restoration 3.Depth of lesions being <1 mm and cervico- occlusal height <2mm 4.Patients willing to participate in study for 6 months 5.Patients with good oral hygiene.

排除标准

  • •1.Carious teeth 2.Patients with history of spontaneous pain / sinus tract 3.Patients with class V lesions extending below cemento-enamel junction 4.Patients having parafunctional habits 5.Patients using any desensitizing toothpaste or mouthwash
  • •Patients with active periodontal disease or those who have undergone periodontal surgery during last 6 months 7.Patient allergic to resin based materials 8.Asthmatic patients 9.Patients taking regular NSAIDS, psychotropic drugs or medications for other systemic diseases 10.Pregnant or lactating mothers.

结局指标

主要结局

Patients will be evaluated for presence or absence of post operative sensitivity after the defined recall period.

时间窗: 24 hours, 1 month, 3 months, 6 months

次要结局

  • Intensity of post operative sensitivity will serve as the secondary outcome for the study. Report from patient regarding dentinal hypersensitivity, air blast test and cold water will be recorded and scored according to Visual Analogue Scale(VAS scale).(24 hours, 1 month, 3 months, 6 months)

研究者

发起方
Dr Surbhi Gupta
申办方类型
Other [self]

研究点 (1)

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