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临床试验/CTRI/2024/02/063023
CTRI/2024/02/063023已完成不适用

To compare the Detection Rate And Ease Of Locating Root Canal Orifice in Primary Molars Using Surgical Loupes, Fluorescein Sodium Dye And Methylene Blue Dye: An In-Vivo Study

Dr Vaibhavi Pharne1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年3月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
To compare the detection rate and ease of detection of root canal orifices of primary

研究概览

简要总结

Introduction-

The major goal of root canal treatment is the thorough mechanical and chemical debridement of all root canals and their complete obturation with an inert filling material and a coronal filling preventing ingress of microorganisms. One of the main reasons for the failure of root canal therapy is the lack of sufficient knowledge concerning the anatomy of teeth, both internal and external.

Presence of accessory canals and rare anatomical configuration makes canal orifice location an important step in pulpectomy and emphasizes the need for the operator to be aware of and look out for such variations and use adequate diagnostic methodologies prior to and during therapy to detect such variations. The presence of additional canals makes it difficult to visualize additional canals like Mesio-buccal 2(MB2) and Mid mesial (MM) canal may serve as a major hindrance towards a successful outcome.

Hence, this study is planned to compare the detection rate and ease of locating root canal orifices of primary molar using surgical loupes, fluorescein sodium dye and methylene blue dye.

Methodology-

This is an in-vivo experimental trial to be carried out in department of pedodontics. Each calibrated operator will administer local anaesthesia using 2% Lignocaine with adrenaline for the procedure. Caries excavation and access opening will be achieved using round bur. The coronal pulp tissue will be amputated using a sharp sterile discoid type spoon excavator.

The Sodium Fluorescein will be prepared using Sodium Fluorescein strips. It will be dissolved in 2ml of normal saline and 2ml solution in a syringe chamber will be flooded with the dye and allow in the pulp chamber for 20 seconds. The excess dye will be evacuated with a suction apparatus. Blue curing light from photopolymerization unit illuminate the chamber. The root canal orifice will show a bright green fluorescence.

For the use of methylene blue dye- dentine will be removed where the root canal orifices are expected and 1-3 drops of dye will be inserted to the bottom of pulp cavity. After 5-10 seconds. Next the pulp cavity will be rinsed and dried. Points intensive dyed in blue will indicate the root canal orifices.

The operators will be asked to visualize the orifice of the canals. The operator 1 will locate the canals with surgical loupes and note the number of orifices followed by Operator 2 who will locate the canals using Sodium Fluorescein dye (Flurostripsterileâ„¢ sodium ophthalmic strip) or methylene blue dye and note the number of orifices.

The operators will also be asked to rate the ease of locating the no canal orifices using the different aids on a five-point Likert rating scale.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Patients with caries in primary molars involving pulp Primary molars with atleast two third of root present Patients with no systemic disease.

排除标准

  • Patient with any systemic disease Patient with more than two third root resorption in primary molars Non restorable primary molars Uncooperative patient.

结局指标

主要结局

To compare the detection rate and ease of detection of root canal orifices of primary

时间窗: At the time of start of treatment

molar using surgical loupes, canal detector dye (methylene blue) and fluorescein sodium.

时间窗: At the time of start of treatment

次要结局

  • To evaluate detection rate and ease of detection of root canal orifices of primary molar using surgical loupes(To evaluate detection rate and ease of detection of root canal orifices of primary molar using canal detector dye (methylene blue))

研究者

发起方
Dr Vaibhavi Pharne
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vaibhavi Vijay Pharne

Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College

研究点 (1)

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