Comparative evaluation of clinical and radiographic success of Biodentine and Bioceramic as a pulp medicament after Laser and conventional pulpotomy in primary molars- A double blinded randomized controlled trial.
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- Dr S Dhivya Shanthi
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- All cause morbidity at 3 months. Success rate of pulpotomy at 3 months (defined as absence of clinical symptoms and radiographic signs of pathology).
概览
简要总结
The aim of the study is to determine the clinical and radiographic success of biodentine and bioceramic as a pulp medicament after laser and conventional pulpotomy in primary molars.
Dental caries have a higher prevalence rate in children, especially in mixed dentition period due to their diet pattern change or lack in maintaining proper oral hygiene.
In case of dental caries with pulpal involvement, preserving the natural tooth by pulp therapy until its time of exfoliation is a vital aim in pediatric dental management, as they are said to be the most best space maintainers.
Vital pulpotomy is the clinical treatment of choice for primary teeth with exposed pulp.
Objectives:
· To use laser as a pulpotomy material in comparison with the gold standard glutaraldehyde pulpotomy.
· To assess the clinical and radiographic success rate of glutaraldehyde pulpotomy and laser pulpotomy.
· To compare the success rate of two different materials- biodentine and bioceramic as a medicament for pulpotomy.
Methodology:
Total sample size 60 collected from OPD,Department of Pediatric and Preventive Dentistry, APDCH and samples are divided into 4 groups . Group1 -15 no for Glutaraldehyde pulpotomy and Biodentine. Group2- 15 no for glutaraldehyde pulpotomy and Bioceramic. Group3- 15 no for laser pulpotomy and Biodentine. Group4- 15 no for laser pulpotomy and Bioceramic. After administration of local anesthesia, the teeth will isolate with rubber dam. The soft carious lesions will first excavate using a spoon excavator, followed by which access opening will perform using no-330 high-speed bur with the airotor. Following the initial drop into the pulp chamber, the tooth will reassure by operative diagnosis by analyzing the nature of the pulpal bleeding. If the nature of bleeding is cyanotic instead of inflammatory, then the teeth will dismiss for pulpectomy and will eliminate from the study. Satisfying the operatory diagnosis, the treatment will continue, the pulp chamber is completely deroofed. The coronal portion of the pulp will excise leaving behind the intact untouched radicular pulp, and finally, irrigation will be done with saline to remove the dentinal debris. A cotton pellet dipped with saline will be placed over the root canal orifice, and pressure is applied to attain hemostasis, followed by which glutaraldehyde pulpotomy and laser pulpotomy will be carried in their respective groups. For glutaraldehyde pulpotomy, a cotton soaked with glutaraldehyde will place over the amputated radicular pulp area over the root canal orifice for 4 minutes. (Garcia Godoy -1987). Upon removal of the cotton pellet, a dark brown layer of fixation can be appreciated. Over this, a biodentine in one group and bioceramic in another group will be placed, and access cavity restoration is done using glass ionomer cement (GIC). For laser pulpotomy, the pulp will be ablated to the level of the canal orifice using diode laser with 980 nm wavelength, 0.8 W of power and on pulse mode. The laser energy will deliver through a 0.5 mm diameter optical fiber in contact with pulp tissue with the total energy of one spot, corresponding to 2 minutes. If additional ablation is required, subsequent multiple applications will be administered. Over this, a biodentine in one group and bioceramic in another group will be placed, and access cavity restoration is done using glass ionomer cement (GIC) type II. Pre- and postoperative radiographs will be taken. The children will be initially assessed on the same day and will be recalled for clinical and radiographic follow-up at 1 and 3months.
Clinical and radiographic success and failure rate will be evaluated based on Zurn & Seale (2008) scoring system.
Inclusion criteria:
- Primary molar tooth not more than one-third of root resorption.
- Children with deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
Exclusion criteria:
- Children with special health care needs
- Children under systemic illness
- Primary molars with any congenital deformities.
**Statistical analysis:**Chi-square test will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Primary molar tooth not more than one-third of root resorption.
- •Children with deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
排除标准
- •Children with special health care needs and systemic illness Primary molars with any congenital deformities.
结局指标
主要结局
All cause morbidity at 3 months. Success rate of pulpotomy at 3 months (defined as absence of clinical symptoms and radiographic signs of pathology).
时间窗: baseline, 3 months
次要结局
- All cause morbidity at 1, 3 months. Incidence of post-operative pain,(Incidence of post-operative infection,)
研究者
Dr DHIVYA SHANTHI
Adhiparasakthi Dental College and Hospital