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临床试验/CTRI/2024/04/065848
CTRI/2024/04/065848已完成4 期

Comparative assessment of different obturating methods in primary teeth using digital radiography: an in vivo study.

Department of Pediatric and Preventive Dentistry1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月25日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Quality of Obturation and presence of voids

研究概览

简要总结

AIM

To compare and assess different obturation  techniques  in primary teeth using digital radiography.

OBJECTIVES

1.     To assess the efficacy of different obturation  techniques  in primary teeth using digital radiography.

2.     To compare the efficacy of different obturation  techniques  in primary teeth using digital radiography.

MATERIALS AND METHODS

Study design â€“ Single Blinded Randomized Clinical trial

Study subjects â€“ Children between the age group of 5-8 years

Sample size â€“ 120 canals

Sample selection: The study sample will include children between the age group of 5-8 years with carious deciduous molar teeth visiting the department of Pediatric and Preventive Dentistry.

Group I – Tuberculin syringe with metal tip

Group II: Tuberculin syringe with plastic tip.

Group III: Lentulo-spiral

Group IV: Past inject carrier

CRITERIA FOR SAMPLE SELECTION –

INCLUSION CRITERIA:

1.    Primary molar indicated for pulpectomy among the children of either sex ranging between 5-8 years of age.

2.    Radiographically teeth with 2/3rd root remaining.

EXCLUSION CRITERIA:

1.     Teeth with caries extending to the furcation.

2.     Root canals with evidence of internal or external resorption

3.     Developmental tooth anomalies

4.     Children with any systemic disease

PROCEDURE â€“

A total sample of 120 canals of primary molar teeth with 2/3rd of root length will be selected which require pulpectomy and will be randomly allocated using chit system into four different obturating techniques, i.e., Group I: Tuberculin syringe with metal tip, Group II: Tuberculin syringe with plastic tip, Group III: Lentulo-spiral, and Group IV: Past inject carrier. Under isolation with rubber dam access cavity will be prepared in each tooth and the infected necrotic pulp tissue will be removed. Working length will be determined and established 1 mm short of the radiographic apex. Biomechanical preparation of the canals will be done till 35 K-file (21 mm). The canals will be repeatedly irrigated alternatively with 1% sodium hypochlorite solution and saline. After instrumentation is complete, the root canals will be dried using absorbent paper points. Post this, all canals will be obturated with Endoflas using the obturating technique assigned to that individual root canal. The quality of obturation, density and presence or absence of voids will be evaluated using digital radiography.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
5.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Primary molar indicated for pulpectomy among the children of either sex ranging between 5-8 years of age.
  • Radiographically teeth with 2/3rd root remaining.

排除标准

  • Teeth with caries extending to the furcation.
  • Root canals with evidence of internal or external resorption
  • Developmental tooth anomalies
  • Children with any systemic disease.

结局指标

主要结局

Quality of Obturation and presence of voids

时间窗: Quality of Obturation and presence of voids at baseline.

次要结局

  • Technique with best quality of obturation which is easier for the operator & well accepted for the child.(During obturation of the teeth at baseline.)

研究者

发起方
Department of Pediatric and Preventive Dentistry
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Mansi Baviskar

Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai.

研究点 (1)

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