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临床试验/CTRI/2025/07/090548
CTRI/2025/07/090548尚未招募不适用

Assessment of quality of obturation of root canals of primary molars using two pediatric rotary file systems: A comparative clinical study.

DR SANJANA CHAKRAPANI1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate and compare the quality of obturation of root canals of primary molars following preparation with Kedo-S Plus and Kedo Nano plus pediatric rotary file systems.

研究概览

简要总结

Sixty primary molars will be allocated by simple randomization technique to two groups of 30 teeth each:

Group I: Root canals will be prepared using Kedo-S Plus rotary file. (Kedo Dental, India)

Group II: Root canals will be prepared using Kedo Nano plus rotary file. (Kedo Dental, India)

Prior to the procedure pre-operative intra-oral periapical radiograph of the primary molar will be obtained. Local anaesthesia will be administered with 2% lignocaine hydrochloride containing adrenaline at a concentration of 1:80000. Dental caries and overhanging enamel will be removed with a #330 high speed bur under a water spray. Access to the coronal pulp chamber will be obtained using a #4 round bur (Dentsply) and the entire roof of pulp chamber will be removed. Necrotic tissue from the pulp chamber will be removed using a sterile and sharp spoon excavator. After obtaining straight line access, patency of the canal will be established using a No.10 stainless steel K-file. Working length will be determined 1mm short of the radiographic apex. The canals will be prepared using rotary file with copious saline irrigation.

In Group I, Kedo-S Plus rotary file and in Group II, Kedo Nano Plus rotary file systems will be used for cleaning and shaping the root canals, according to manufacturer’s instructions. Irrigation with saline will be carried out. Canals will be dried with absorbent paper points and obturated with zinc oxide eugenol cement (Zinc Oxide, DPI® ZINC OXIDE Manufactured by Dental Products of India) (Eugenol, Prevest DentPro, India) using incremental filling technique. The primary molar will be then restored with Type II glass ionomer cement (Shofu, Shofu Inc. Japan). An immediate post-operative intra-oral periapical radiograph of the primary molar will be taken. All the treated primary molars will be given stainless crowns within 1 week of treatment.

Assessment of quality of obturation

The quality of obturation will be assessed according to Mahtab Memarpour et al.

1=less than or equal to half the root canal length was filled

2=more than half the root canal length was filled but filling was not optimal

3=optimal filling (canal filled to within 0-1.5 mm of the apex) and

4=filling material extruding from the apex (overfilling)

The presence or absence of voids, number and location of voids in each root canal (coronal, middle, apical) will also be evaluated.

Data obtained will be subjected to statistical analysis.

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

  • 1.Young cooperative children with no history of systemic illness 2.Tooth with carious pulp exposure, diagnosed as having irreversible pulpitis 3.Tooth with at least 2/3rd of root length present 4.Tooth showing radiographic signs of pulpal or interradicular pathosis.

排除标准

  • Children with special health care needs
  • Tooth with severe mobility
  • Pathologic bone loss.

结局指标

主要结局

To evaluate and compare the quality of obturation of root canals of primary molars following preparation with Kedo-S Plus and Kedo Nano plus pediatric rotary file systems.

时间窗: 1 week

次要结局

未报告次要终点

研究者

发起方
DR SANJANA CHAKRAPANI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR SANJANA CHAKRAPANI

The Oxford Dental College

研究点 (1)

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