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临床试验/CTRI/2018/03/012667
CTRI/2018/03/012667已完成1 期

Comparative Evaluation of Disinfecting Potential of Sodium Hypochlorite, Diode Laser And Photodynamic Therapy In Non- vital Teeth With or Without Periapical Rarefaction - A Double Blind Randomized Clinical Study

Sadhana Rai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月4日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To reduce microbial load in root canals of non vital teeth with or without periapical lesion using proposed disinfecting protocols.

研究概览

简要总结

This study is a Double Blind Randomized Clinical Study to compare and evaluate the Disinfecting Potential Of Sodium Hypochlorite, Diode Laser And Photodynamic Therapy in Non-vital Teeth With Or Without Periapical Rarefaction. The study will be conducted inSRM Dental college, Ramapuram and the microbial analysis will be done in Sri Ramachandra Dental College, Porur. The primary outcome is to reduce microbial load in root canals in nonvital teeth with or withour periapical lesion using Sodium Hypochlorite, Diode Laser and Photodynamic therapy. Secondary outcome is to promote periapical healing, no clinical signs and symptoms of pain, swelling, tender on percussion and sinus tract.

This in vivo study follows double blind randomized clinical trial performed by 3 operators. 1st operator diagnoses and allots the patients randomly in either one of the disinfection group after diagnosis.The respective disinfection protocol groups were as follows:

• Group I: 5.25% Sodium hypochlorite (n=15)

• Group II: 808nm Diode laser (n=15)

• Group III: 660nm Diode laser with methylene blue dye(n=15)

The 2nd operator does the access opening using a sterile round bur and rotary hand piece. Canals were negotiated using 10# k hand file and working length determination was done using apex locator. Followed by cleaning and shaping with rotary Protapers (F4 size) along with EDTA and copious irrigation of sterile saline. Disinfection of the root canals were done using one of the disinfecting protocols according to the respective allotted group.

• Group I: Canals irrigated with 1mL of 5.25% NaOCl for 2 minutes using 27 guage needle.

• Group II: Canals irradiated with 808 nm diode laser with 0.1-7mW for 30 seconds

• Group III: Photosensitizer(Methylene blue) allowed to remain in the canal for 5mins, followed by irradiation with 660nm diode laser for 4mins.

The 3rd operator takes the pre instrumentation and post disinfection sample using paper points. The collected samples were subjected to flow cytometer in order to analyze pre and post live microbial count.

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, Investigator and Outcome Assessor 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.Patients with PAI score 1, 2 and 3 2.Patients categorized under ASA 1and 2 3.Patients with non vital teeth with or without periapical rarefaction in single rooted teeth with closed apices, all indicated for root canal treatment.

排除标准

  • 1.Patients categorized under ASA 3 and
  • 2.Patients with PAI score 4 and
  • 3.Patients who underwent 1 week of systemic antibiotic therapy.
  • 4.Patients with non vital teeth with severe root curvature of more than 45 degree.
  • 5.Patients with endo-perio lesions 6.Patients with root canal attempted teeth, fracture teeth, calcified root canals, root resorption and re-infection in endodontically treated teeth.

结局指标

主要结局

To reduce microbial load in root canals of non vital teeth with or without periapical lesion using proposed disinfecting protocols.

时间窗: 5 min

次要结局

  • To promote periapical healing, no clinical signs and symptoms of pain, swelling, tender on percussion and sinus tract.(7 days)

研究者

发起方
Sadhana Rai
申办方类型
Other [self]

研究点 (1)

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