跳至主要内容
临床试验/CTRI/2025/09/095394
CTRI/2025/09/095394尚未招募Phase 3 4

Comparative evaluation of antibacterial efficacy of various intracanal irrigating solutions in pulpectomy procedures in primary teeth- an in vivo study

Dr. Aarzoo Dogra1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To evaluate and compare the antibacterial efficacy of various intracanal irrigating solutions: Triton New All-in-one, 2.5% Sodium hypochlorite, 17% Ethylene diamineacetic acid (EDTA) and Normal Saline in pulpectomy procedures in primary teeth

研究概览

简要总结

The study protocol will be explained to the parent or guardian. A written informed consent will be obtained prior to initiating the treatment. A total of eighty primary teeth requiring pulpectomy will be selected from children aged 4 to 8 years and isolated using a rubber dam following the administration of local anesthesia. A sterile round bur #41 will be used to create an initial access opening. Subsequently, a sterile round bur #46, mounted on a high-speed handpiece, will be employed to further access the pulp chamber and eliminate any dentinal ledges obstructing a direct pathway to the canal orifices. On gaining the access, a sterile paper point will be inserted to obtain root canal content which will then be immediately transferred to a test tube containing transport media. The tube will be tightly sealed for the further transfer to microbiological laboratory. This will constitute the “pre-irrigant culture”.

 After collecting the “pre-irrigant culture” the teeth will be randomly and equally distributed amongst the following four groups on the basis of sequentially numbered opaque sealed technique (SNOSE).

GROUP I- (n=20) Teeth to be irrigated with Triton New All-in-one irrigating solution

GROUP II- (n=20) Teeth to be irrigated with Sodium hypochlorite (3%) irrigating solution

GROUP III- (n=20) Teeth to be irrigated with Ethylenediaminetetraacetic acid (17%) irrigating solution

GROUP IV- (n=20) Teeth to be irrigated with Normal saline (control)

The endodontic therapy including root canal irrigation will be double blinded.

 On the same day, the working length determination and biomechanical preparation will be performed using files three sizes larger than the initial instrument. Throughout the instrumentation, the root canal will be intermittently irrigated with 2ml of the designated irrigant after each step:

GROUP I: During biomechanical preparation, canal will be irrigated with Triton New All-in-one irrigating solution using a sterile syringe with side vented needle that does not bind to the canal walls. The canal will then be dried with a sterile paper point. Following this, another sample will be taken for culture in an identical manner to pre-irrigant culture method. This will constitute the “post-irrigant culture”. The samples will be transferred to a test tube and sent to the microbiology department for analysis.

 GROUP II: During biomechanical preparation, canal will be irrigated with 3% Sodium hypochlorite irrigating solution using a sterile syringe with side vented needle that does not bind to the canal walls. The canal will then be dried with a sterile paper point. Following this, another sample will be taken for culture in an identical manner to pre-irrigant culture method. This will constitute the “post-irrigant culture”. The samples will be transferred to a test tube and sent to the microbiology department for analysis.

 **GROUP III:**During biomechanical preparation canal will be irrigated with 17% EDTA irrigating solution using a sterile syringe with side vented needle that does not bind to the canal walls. The canal will then be dried with a sterile paper point. Following this, another sample will be taken for culture in an identical manner to pre-irrigant culture method. This will constitute the “post-irrigant culture”. The samples will be transferred to a test tube and sent to the microbiology department for analysis.

 GROUP IV: During biomechanical preparation canal will be irrigated with Normal saline (control group) using a sterile syringe with side vented needle that does not bind to the canal walls. The canal was then dried with a sterile paper point. Following this, another sample will be taken for culture in an identical manner to pre-irrigant culture method. This will constitute the “post-irrigant culture”. The samples will be transferred to a test tube and sent to the microbiology department for analysis.

 **Microbiological Study:**The screw-capped test tube will be vigorously shaken to ensure uniform dispersion of the sample inside. The inoculum will be obtained from the inoculated Thioglycollate Broth (HIMEDIA, Mumbai, India), and a calibrated loop with a 3.26 mm diameter, containing 0.004 mL of broth, will be used for inoculation. The sample will be streaked onto two sheep blood agar plates—one for aerobic and the other for anaerobic bacterial culture.

For the pre-irrigation sample, the aerobic culture plate will be incubated for 24 hours, while the anaerobic culture plate will be incubated for 48 hours in an anaerobic chamber with a Gas-Pak System (HIMEDIA, Mumbai, India). bacterial count will be calculated. Similarly, for the post-irrigation sample, both aerobic and anaerobic culture plates will be incubated, and bacterial colonies will be enumerated accordingly.

COLONY FORMING UNITS (CFU) –

CFU =  n×d

s

 where  c= concentration, CFU/ml

n= number of colonies

d= dilution

s= volume transferred to plate

Teeth in each group will be obturated using Endoflas followed by post obturation filling. The results of the present study will be tabulated and will be statistically analysed.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Restorable teeth.
  • Teeth with persistent pain.
  • Teeth with sensitivity to hot or cold.
  • Teeth with at least two third root length.
  • No radiographic evidence of internal or external root resorption.
  • No radiographic evidence of pulpal floor perforations.

排除标准

  • Grossly decayed teeth.
  • Presence of dentigerous or follicular cyst.
  • Periradicular pathosis involving the permanent tooth bud.
  • Children with known systemic disease.
  • Teeth with class II,III mobility (Miller’s Criteria).

结局指标

主要结局

To evaluate and compare the antibacterial efficacy of various intracanal irrigating solutions: Triton New All-in-one, 2.5% Sodium hypochlorite, 17% Ethylene diamineacetic acid (EDTA) and Normal Saline in pulpectomy procedures in primary teeth

时间窗: sample from the canal will be taken before and after irrigation. incubation will be done for 24 hours for aerobic analysis and 48 hours for anaerobic analysis.

次要结局

未报告次要终点

研究者

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

Dr Meenu Bhola

Dasmesh Institute of Research and Dental Sciences

研究点 (1)

Loading locations...

相似试验