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.
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:
- number of operaters will be restricted two, with similar level of experience in order to minimize operater variation
- the investigator and co investigator will calibrate each other on the sequence of the procedure and assessment to enhance standardization of procedure
- local anaesthesia will be given to patients using lidocaine 2% solution available for dental use in 1.8 ml carpule
- rubber dam will used for isolation and moisture control in the working field.
- the tooth to be restored will be seperated from the adjacent tooth using wooden wedges.this will allow seperation of teeth.
- 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
- 否
入选标准
- •patient requiring treatment for class 2 cavity
- •patient age 12 to 55 years
- •Maxillary and Mandibular first and second premolar
- •Maxillary and Mandibular first and second molar
- •Maximum occlusal cavo surface width of 2/3rd of intercuspal width
- •Cavity depth upto 3/4th of occlusocervical length measured from diagnostic radiograph
- •Teeth with adjacent fully erupted teeth adjacent to a cavity side
排除标准
- •Mentally and physically handicapped patient 2)Pregnant females 3)Patients with naturally spaced teeth 4)Patients with moderate or advanced periodontitis 5)Endodontically treated teeth 6)Teeth with excessive occlusal wear and erosion of teeth 7)Tooth adjacent to cavity side is missing 8)Teeth with orhtodontic bands and brackets 9)Tooth adjacent to cavity side is restored
研究组 & 干预措施
Precure composite insert technique
After curing of bonding agent a 2mm increment of composite will be placed on the gingival floor of the cavity and cured. a measured volume of composite(3mm height and 2mm width) will be cured outside the oral cavity on a flat plastic instrument for 40 seconds. a second increment of composite will be placed on the cavity and the precured composite will be pressed in the uncured increment and pressed outward against the matrix band and light cured for 20 seconds the rest of the cavity will be filled using the oblique layering technique.
干预措施: precured composite insert technique (Procedure)
Contact Making Instrument
a 1-2mm increment of the composite will be placed in the gingival floor of the proxial box.
a contact forming instrument will be placed in this uncured increment and an outward force will be applied using the instrument from the inside of the matrix band. The composite will then be cured for 20 seconds to achieve a tight contact.
干预措施: Contact making instrument (Procedure)
Incremental composite layering technique
Increments will be placed in 1-2mm increments in oblique layering manner by a flat plastic instrument and condenser .Each increment will be cured for 20 seconds till the cavity is slightly overfilled.
干预措施: Incremental composite layering technique (Procedure)
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