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临床试验/NCT03233893
NCT03233893Unknown不适用

Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Light Activated Calcium Hydroxide in Management of Simple Deeply Seated Carious Lesions With Partial Caries Removal

Cairo University0 个研究点目标入组 60 人开始时间: 2018年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
calcific bridge formation will be measured by digora software

研究概览

简要总结

sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal according to the capping material (A),where (A1)represents calcium silicate group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group (A1) in deep occlusal caries and taking the base line image after restoring the cavity with composite restoration and apply light activated calcium hydroxide for(A2)group in deep occlusal caries and taking the base line image after restoring with composite restoration.Take follow up image after one year to measure the calcific bridge formation for both groups.

详细描述

Management of deep carious lesion may constitute a real challenge for the operator.The basic idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide has been the gold standard as a capping material but there are some drawbacks like solubility,gaps formation and mechanical instability so a need for a capping material such as calcium silicate has shown several advantages.

Sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal.The first group(A1) will be treated by light activated calcium silicate and the second group(A2) will be treated by light activated calcium hydroxide after partial caries removal of deep occlusal caries then restore by composite restoration.Paralleling technique using film holders and custom made bite blocks will be used to standardize the serial radiographs and to prevent the distortion of the radiographic image.An increase in dentin thickness will be measured through sequential imaging by soft ware named Digora (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the scanned image.All images will be studied carefully for an increase in dentin thickness keeping the reference point constant from the furcation area.

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 (Participant, Outcomes Assessor)

盲法说明

The patient and the outcome assessor will be blinded in this study

入排标准

性别
All
接受健康志愿者

入选标准

  • Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history.
  • Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus.

排除标准

  • Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study.
  • Pregnant females will be excluded from the study.

研究组 & 干预措施

light activated calcium silicate

Experimental

Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.

干预措施: light activated calcium silicate (Other)

light activated calcium hydroxide

Active Comparator

Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.

干预措施: light activated calcium silicate (Other)

结局指标

主要结局

calcific bridge formation will be measured by digora software

时间窗: 1 year

in millimeters

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

basma gamal hassan

Resident of conservative department ,faculty of oral and dental medicine

Cairo University

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