Comparison and Effectiveness of the Manual File System, the Multi-file Rotating System and the Single File Reciprocating System in Temporal Molars
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate instrumentation time with K, Rotate and Reciproc Blue files.
研究概览
简要总结
Is an in vivo study to test the effectiveness of the reciprocating system Reciproc blue and the rotating system VDW.ROTATE in primary molars.
详细描述
It is a randomized controlled clinical study to be conducted in the Department of Pediatric Dentistry of the International University of Catalonia (UIC).
The clinical study and data collection will be obtained by the second year students of the master's degree in Pediatric Dentistry. All of them will receive the same practical and theoretical training on the treatment to be performed, and will be calibrated by the principal investigator. The procedure and the data obtained will be reviewed by a trained investigator and blinded with the type of procedure used.
Children from 4 to 8 years old will be selected to visit the Clinica Universitaria de Odontología (CUO) with the master's degree in Pediatric Dentistry. A sample of 60 children will be taken. There will be three study groups, where 20 subjects will be assigned to each, estimating a follow-up loss ratio of 20%.
Once the patient is selected, they will be assigned to one of the groups in order of arrival. For example, patient one will be assigned in group 1, patient two in group 2, patient three in group 3 and so on.
There are 3 study groups groups: Group 1, with Manual instrumentation with K files (Dentsply Caulk, Milfors, DE, USA); group 2, with the VDW.ROTATETM (VDW, Munich, Germany); and group 3, with Reciproc® Blue (RCP, VDW, Munich, Germany) system.
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, Investigator)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vital or non-vital temporary lower second molars.
- •Radiographic absence of external or internal pathological reabsorption.
- •Absence of interadicular radioluscience and/or periapical lesion.
- •Temporary teeth with at least 2/3 of the root intact or a minimum root length of 8mm.
- •Remaining dental structure sufficient for the subsequent placement of a stainless steel crown.
- •Children who have already undergone some previous restorative treatment in the Department of Pediatric Dentistry.
排除标准
- •Molars that have less than 2/3 radicular lenght.
- •Have taken analgesics or anti-inflammatories in the last 12 hours.
- •Very uncooperative patients, who require some type of anxiety to be treated.
- •Patients with systemic diseases.
- •Patients with special needs.
研究组 & 干预措施
K files (Dentsply Caulk, Milfors, DE, USA)
Instrumentation with manual files shall be performed with balanced forces (Roane) technique consist of placing the instrument as apically as it can go and then turning it clockwise (less than 180º). This is followed by a counterclockwise rotation (of at least 120º) with slight apical pressure. This is repeated until the desired working length is obtained.
干预措施: instrumentation technique in pulpectomies (Device)
VDW.ROTATE (VDW, Munich, Germany).
Instrumentation with VDW.ROTATE files shall be performed with a glide path to WL using VDW.ROTATETM 15.04 until reaching working length (1.3cNm and 300-400 rpm), the next instrument in the sequence is VDW.ROTATETM 20.05 until reaching working length (2.1cNm and 300-400rpm). and finally instrument with VDW.ROTATETM 25.04 (2.3cNm and 300-400rpm)
干预措施: instrumentation technique in pulpectomies (Device)
Reciproc® blue (RCP, VDW, Munich, Germany)
Instrumentation with Reciproc blue files shall be performed with only one file and move it in a pecking motion (the amplitude will not exceed 3mm). All the instruments shall be cleaned after 3 pecks.
干预措施: instrumentation technique in pulpectomies (Device)
结局指标
主要结局
Evaluate instrumentation time with K, Rotate and Reciproc Blue files.
时间窗: Immediately after instrumentation. From the beginning to the end of the instrumentation with the files
Once the instrumentation and irrigation is finished, the operator will record the time elapsed from the beginning to the end of the instrumentation with the disinfection of the appropriate irrigant. The operator will record the minutes and seconds evaluated with an analog stopwatch.
次要结局
- Evaluate the quality of the filling of the duct without the need of any auxiliary elements with the files K, the Rotate and the Reciproc Blue.(Immediately after the procedure)
- Evaluate the operator ease during instrumentation with K, Rotate and Reciproc Blue files.(Immediately after the procedure)
- Evaluate the child's heart rate during instrumentation with K, Rotate and Reciproc Blue files.(During one week. Evaluation 3 minutes before topical anesthesia, topical anesthesia, local anesthesia, rubber dam, caries removal and coronal pulp tissue elimination, duct instrumentation, rubber dam removed.)
- Evaluate the postoperative pain with the K files, the Rotate and the Reciproc Blue.(at 6, 12, 24, 48, 72 hours and a week later)
- Evaluate the child's behavior comparing to some previous restorative treatment with K, Rotate and Reciproc Blue files.(Immediately after the procedure)
研究者
Francisco Guinot-Jimeno
head of the department of pediatric dentistry
Universitat Internacional de Catalunya