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临床试验/CTRI/2023/02/049703
CTRI/2023/02/049703尚未招募不适用

Clinical And Radiological Comparative Evaluation Of Different Calcium Silicate Based Materials Pro Root MTA, TheraCal LC And TheraCal PT As Direct Pulp Capping Agent In Carious Permanent Tooth: A Randomized Controlled Trial

Dr Radhika Charhate1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年5月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct

研究概览

简要总结

Direct pulp capping (DPC) is a clinical procedure involving the placement of a biomaterial which aims to maintain dental pulp vitality by stimulating the formation of tertiary dentin as a hard-tissue barrier protector. Although many previous studies have done on Pro Root MTA and TheraCal LC as a direct pulp capping agent, but there is limited data available regarding MTA, TheraCal LC and TheraCal PT as a direct pulp capping agent.

Group A (Pro Root MTA group)- MTA will be mixed according to manufacturer’s instructions (i.e., 1:3 water / powder ratio) and applied over an exposed site with a sterile carrier. Cotton pellet soaked in normal saline will be placed over MTA and the cavity will be sealed temperorily with intermediate restorative material Orafil G (prevest denpro, jammu and kashmir, india), after 24 hours the setting of MTA will be evaluated and direct composite restoration tetric n-ceram and tetric n-bond self-etch, (ivoclar vivadent, india) will be placed.

Group B (TheraCal LC) -TheraCal LC will be delivered at the exposure site according to the manufacturer’s instructions. Resin Modified Glass Ionomer Cement (RMGIC) will be placed and patient will be recall after 3 days for permanent restoration with Composite (Tetric n-ceram, Ivoclar Vivadent, India) restoration.

Group C (TheraCal PT) -TheraCal PT will be delivered at the exposure site according to the manufacturer’s instructions. Resin Modified Glass Ionomer Cement (RMGIC) will be placed and patient will be recall after 3 days for permanent restoration with Composite (Tetric n-ceram, Ivoclar Vivadent, India) restoration. The patients will be recall for Clinical and Radiological evaluation after 1,6,12 months intervals.

Clinical evaluation will be perfomed at 1st,6th and 12th months after DPC for history of spontaneous pain, sensibility status of teeth, discoloration of teeth, restoration status, surface texture, anatomic form, secondary caries, post-operative sensitivity, marginal discoloration and marginal integrity.

Radiographic evaluation will be perfomed at 1st,6th and 12th months. After 1 st,6 th and 12th months of direct pulp capping, digital periapical radiographs will be taken and submitted to image analysis CoralDRAW X7 Software (coral corporation, Ontario, Canada) 1 st - and 6 th -month radiographs will be overlapped. Radiographs will be adjusted in the software to fit in the measurement of 41 mm ×31mm.Qualitative assessment of the radiograph will be done to find whether the reparative dentin is visible or not.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • deep carious lesion, healthy co-operative patient, caries to the occlusal surface, Positive response to thermal and electric pulp tests,Sensitivity to cold food,.No radiographic evidence of periapical pathology.

排除标准

  • 未提供

结局指标

主要结局

To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct

时间窗: To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct | pulp capping agent in carious permanent teeth after 1st,6th | ,12th month interval.

pulp capping agent in carious permanent teeth after 1st,6th

时间窗: To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct | pulp capping agent in carious permanent teeth after 1st,6th | ,12th month interval.

,12th month interval.

时间窗: To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct | pulp capping agent in carious permanent teeth after 1st,6th | ,12th month interval.

次要结局

  • To evaluate and compare radiologically Pro Root MTA, Theracal LC and Theracal PT as a direct pulp capping agent in carious permanent tooth after 1st,6th,12th month interval.(To evaluate and compare radiologically Pro Root MTA, Theracal LC and Theracal PT as a direct pulp capping agent in carious permanent tooth after 1st,6th,12th month interval.)

研究者

发起方
Dr Radhika Charhate
申办方类型
Other [self]

研究点 (1)

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