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临床试验/CTRI/2024/09/074059
CTRI/2024/09/074059已完成3 期

COMPARATIVE EVALUATION OF CANAL TRANSPORTATION,CENTERING RATIO AND POSTOPERATIVE PAIN FOLLOWING GLIDEPATH PREPARATION:A RANDOMIZED CLINICAL STUDY

Dr MONISHAR1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
evaluating canal transportation,cenetring ratio and postoperative pain in all the 3 groups and comparing 3 groups

研究概览

简要总结

This in vivo study will be conducted on human mandibular first molar satisfying inclusion and exclusion criteria. Forty-five patients between age group of 18 to 60years with mandibular first molar indicated for root canal treatment and who signed informed consent will be selected for the study.

Pre operative CBCT will be taken to determine root curvature using Schneiders classification. Patients with mesial root of teeth with canal curvature of 10 to 30 degree (moderately and severely curved root canals) according to Schneider’s classification will be selected as samples for the study (n =15).

Patients will be anaesthetized with 1.8ml of 2% lignocaine with 1:80000 adrenaline by inferior alveolar nerve block. After rubber dam isolation access cavity will be  prepared using endo access bur using high speed handpiece. The subjects will be randomly assigned to one of the three groups according to the glide

path instrument by choosing a sealed envelope containing the group name.

 Group 1: Negotiation and glide path preparation in the mesial canal in this group will be performed using hand K files in the following order #10, # 15 and #20.

 Group 2: A #10 hand K file will be used for negotiation of mesial canal. Jizai glider of 013 tip size, 0.04 taper at 500 revolutions per minute with a torque setting of 3.0 Newton will be used for glide path preparation.

 Group 3: A #10 hand K file will be used for negotiation of mesial canal. Trunatomy glider of size #17.02 progressive taper at 500 revolutions per minute with a torque setting of 1.5 Newton will be used for glide path preparation.

 After completion of glide path preparation, each canal will be rinsed with 3ml of 5.25% NaOcl. The CBCT scans of the patients will be obtained and images will be saved. Canal transportation and centering ratio in all groups will be calculated by the investigator.

 CBCT measurements

To calculate the magnitude of transportation of the mesiobuccal canal, the following formula will be used:

Pre and post instrumentation measurements of canals were achieved using the three-dimensional CBCT. Canal transportation and centering ratio will be calculated at three cross sections of 3, 6 and 9mm from apical end using the following equation.

Magnitude of transportation = (M1-M2) – (D1-D2).5

To calculate centering ratio of mesiobuccal canal:

Centering ratio = (M1 -M2)/ (D1-D2)5

M1 represents the distance between mesial portion of the root and uninstrumented canal, M2 is the distance between mesial portion of the root and the instrumented canal. D1 represents distance between the distal portion of the root and uninstrumented canal, D2 is the distance between the distal portion of the root and instrumented canal.5

The pre and post instrumentation CBCT images will be superimposed using the care stream software.

After glide path preparation further working length determination, cleaning and shaping with their own respective file systems, irrigation and obturation will be carried out. Patients will be followed up to record postoperative pain.

 Postoperative pain**:**

Postoperative pain will be recorded at 12, 24 ,48 and 72 hours after the treatment using a visual analogue scale (VAS).

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.systemically healthy adult patients aged 18 to 60 years with irreversible pulpitis in mandibular first molar indicated for root canal treatment.
  • 2.mandibular first molar with mesial canal curvature between 10-30 degree.
  • 3.Pulp diagnosed with irreversible pulpitis and normal periapical tissues.

排除标准

  • 1.For standardization the canals that naturally had a smooth glide path to apex negotiated by #15k file or larger were excluded.
  • 2.medically compromised patients.
  • 3.pregnant women 4.previous endodontic treatment.
  • 5.calcified canals.
  • 6.Teeth with resorption 7.Immature apex.

结局指标

主要结局

evaluating canal transportation,cenetring ratio and postoperative pain in all the 3 groups and comparing 3 groups

时间窗: 1)Before and After glidepath preparation of the canal . | 2)postoperative pain would be assessed for 12,24,48 and 72 hours.

次要结局

  • To compare the severity of postoperative pain after glide path preparation with manual and rotary glidepath instrument.(postoperative pain recorded at 12,24,48 and 72 hours.)

研究者

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

DR MONISHA R

THE OXFORD DENTAL COLLEGE AND HOSPITAL

研究点 (1)

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