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临床试验/NCT05386498
NCT05386498Unknown不适用

Comparison of Proximal Contacts and Contours in Class II Composite Restoration With Pre-cured Composite Inserts Versus Contact Making Instrument Technique. A Randomized Control Clinical Trial.

Foundation University Islamabad0 个研究点目标入组 180 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
主要终点
Contact tightness and Contour of Class 2 composite restoration

研究概览

简要总结

The objective of this randomized control cinical trial will be to compare the effectiveness of precured composite inserts in obtaining tight and adequate conatacts in class 2 restorations when compared with the contact making instrument technique among patients treated at the operative depatment of Foundation Umiversity College of Dentistry.

This is a single centre based randomized control clinical trial in which intervention arm 1 will get there class 2 restoration done with precured composite inserts and interention arm 2 will recieve treatment with contact making instrument technique. The control arm will recieve restoration using the conventional composite layering technique.

详细描述

Study design : randomized control clinical trial with three intervention arms

Study setting : operative department , foundation university college of dentistry Islamabad Pakistan.

Sample size : the sample size was calculated using the NCSS PASS software. A total od 180 patients will be tested in the study divided in three groups of 60 patients each. Consent will be taken from pateints on a standardized form approved by the ethics review committe in the operatory where the initial assessment will be done.

Procedure:

  1. number of operaters will be restricted two, with similar level of experience in order to minimize operater variation
  2. the investigator and co investigator will calibrate each other on the sequence of the procedure and assessment to enhance standardization of procedure
  3. local anaesthesia will be given to patients using lidocaine 2% solution available for dental use in 1.8 ml carpule
  4. rubber dam will used for isolation and moisture control in the working field.
  5. the tooth to be restored will be seperated from the adjacent tooth using wooden wedges.this will allow seperation of teeth.
  6. cavity preparation will be done using a high speed handpiece(W&H) with a round bur(prima) (no1/6 or 1/4). After initial penetration through enamel the carious lesion will be excavated using a a carbide bur in a slow speed handpiece.

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

Two consultants will be assessors who will be calibrated by demonstration of outcome assessment.

Series of assessments will be done on patients and inter assessor reliability will be determined.

An agreement of 0.7 by intraclass correlation coeffiecient will be considered as good reliability.

At the time of treatment a single assessor out of the two, will be blinded to the treatment allocation and will check the contact tightness of the filling. Masking will be ensured as the assessors will not be present at the time of treatment allocation or at the time of treatment administration and will be involved only once the procedure is complete. Assessment will be done using a waxed floss passed between the filling and the adjacent tooth. Due to interventional nature of the study the treating dentist cannot be blinded to the allocation of treatment.

入排标准

年龄范围
12 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Contact tightness and Contour of Class 2 composite restoration

时间窗: 1 day

The contact tightness and contour of the filling will be assessed using the modified united states public health service system rating scale which has is used in studies on dental materials.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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