Evaluation of accuracy of root canal working length determination methods and their effect on quality of obturation and post operative pain following pulpectomy in primary molars- A comparative randomised clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Effect of working length determination of on quality of obturation,post-operative pain, obturation techniques and outcome of pulpectomized teeth
研究概览
简要总结
A single operator (GB) with clinical experience of more than 20 years will be conducting the pulpectomy procedure in a single appointment except working length determination of the root canals. The study will comprise 128 teeth (384 root canals) from the selected children. Pulpectomy of all the teeth will be done under local anaesthesia. The traditional access cavity of the teeth will be performed and the pulp tissue from the pulp chamber will be removed using a sterile sharp spoon excavator. Straight-line access will be obtained and pulp tissue will be extirpated from the root canal using H-files. The patency of the root canal will be assessed using a #10 K-file.25
Following, the working length of the root canals of all the 128 teeth will be determined by selected three methods: i.e., conventional radiography, digital radiovisiography and an electronic apex locator.
The mean values of the working length taken by 3 methods will be recorded by subtracting 1mm from the length that measured. Measurements of root canal lengths estimated from conventional radiography, intraoral digital radiovisiography and electronic apex locator will be compared with the actual root canal length of the extracted molars obtained using stereomicroscope.
In all the 3 groups, the chemo-mechanical preparation of the root canals will be done with a pediatric rotary file system (Kedo-SG file system -Reeganz Dental Care Pvt. Ltd, India). The root canals of all teeth will be intermittently irrigated with saline. Endoflas® cement will be used as obturating material in all the groups. Rotary #25 lentulospiral method will be used for obturation of teeth. Following, the teeth will be restored with stainless steel crown within one week of obturation and quality of obturation, quality of obturation according to the type of obturation technique used, quality of obturation with and without coronal preflaring and post-operative pain in single and multivisit pulpectomy will be assessed.
All the patients will be recalled at 3, 6, 9 and 12, 18 and 24 months for evaluation of clinical and radiographic success of pulpectomized teeth.
Statistical analysis: Statistical Package for Social Sciences [SPSS] for Windows Version 22.0 Released 2013. Armonk, NY: IBM Corp. will be used to perform statistical analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with primary molars with
- •Necrotic pulp
- •Irreversible pulpitis symptoms
- •Radiolucent areas in the furcation or periapical region, and
- •At least two-thirds of each root remaining.
排除标准
- •Children with primary molars with
- •Structures inadequate for restoration
- •Clinical evidence of pulp pathology (resorption, spontaneous pain, tenderness to percussion/palpation, swelling (intraoral/extraoral) sinus tract, pathological mobility)
- •Perforated pulpal floor
- •Internal or external pathological root resorption
- •Dilacerated roots
- •Calcified/obliterated root canals and
- •Evidence of root fracture.
- •Children requiring special health care needs, with limited or lacking cooperative abilities, or requiring sedation/general anaesthesia for behaviour management and allergy to local anaesthetics and any other drugs.
结局指标
主要结局
Effect of working length determination of on quality of obturation,post-operative pain, obturation techniques and outcome of pulpectomized teeth
时间窗: At end of the intervention for quality of obturation and for the assessment of pain - 6hr, 12, 24, 48, and 72 hours, and at one week
次要结局
- Effect of working length determination methods on technique of obturation & quality of obturation with & without coronal flaring(At end of the intervention for quality of obturation & for the assessment of pain - 6hr, 12, 24, 48, & 72 hours, & at one week)
研究者
DR GIRISH BABU KL
Hassan Institute of Medical sciences
