Antibacterial Effect Of 940nm Diode Laser, Apple Cider Vinegar And Gymnema Sylvestre In Diabetic Patients With Apical Periodontitis Against Peptostreptococcus Species- A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
Methodology
Patient with diabetes 2 with informed consent -convenience sampling over a one year period.The tooth isolated with a rubber dam and the correct disinfection procedures will be used. researcher will do the Access preparation Working length -electronic apex locator (Dentsply Propex II) as well as a radiographic approach.
After the canals will be obturated using ZOE sealer and gutta percha and post endodontic restoration is done using composite restoration. Patient is kept on follow up for 7days, 15 days, 30 days ,45 days and 60 days Clinical outcome is measure using periapical radiograph (RVG) Pain is measured using visual analog scale to mark the pain intensity. Data will be analysed statistically To enlarge the root canals (ISO size 20 file)
A sterile paper point inside the root canal for one minute until the apex of the root canal is reached
Using T.E Buffer, samples will be delivered to the School Of Basic Life Sciences, Sharda University.
The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal.
Grouping Following instrumentation, 5% NaOCl and 17% EDTA irrigation will be done. Control group (n=15) The final irrigant will be saline Group 1 (n=15) Irrigation using 5% apple cider vinegar done The final irrigant will be saline Group 2 (n=15) Diode laser is used for disinfection in the presence of saline Group 3 (n=15) Gymnema Sylvestre Mother Tincture Q 1000 CH solution is used for disinfection in the presence of saline Group 4 (n=15) Diode laser is used for disinfection in the presence of 5% apple cider vinegar. The final irrigant will be saline Group 5 (n=15) Diode laser is used for disinfection in the presence of Gymnema Sylvestre Mother Tincture Q 1000 CH solution. The final irrigant will be saline
After cleaning and shaping, samples will be collected and sent through T.E. Buffer to the School Of Basic Life Sciences, Sharda University.
The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal.
详细描述
Study design and ethical consideration The present study will be a randomized controlled clinical study conducted over the period of one year; the study protocol will be reviewed and approved by the institutional; ethics committee , sharda university. All procedures will be performed in accordance with the ethical standards laid down in the declaration of Helsinki.
Patients diagnosed with type 2 diabetes mellitus will be recruited after obtaining written informed consent. Convenience sampling will be employed due to the clinical nature of the study and availability of eligible patient reporting to the out patient department during the study period. .Randomisation will be done using lottery method Patient selection and sampling method Type 2 diabetic patients fulfilling the inclusion criteria will be selected using a convenience sampling technique over a one year period.
Convenience sampling has been widely used in clinical endodontic trials where strict criteria limit patient availability.
After patient recruitment, the selected tooth will be isolated using the rubber dam to maintain asepsis and prevent salivary contamination, which is critical for accurate microbiological sampling.
Access cavity preparation will be performed using and access opening bur # 2 followed by refinement of the access wall using an endo z carbide bur to ensure straight line access to root canals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Using radiographs, intraoral periapical radiographs (RVG) primary endodontic infection will be selected.
- •Multirooted teeth , root with periapical lesion will be selected
- •Type 2 diabetics between the ages of 25 years and 60 years will be chosen; both male and female patients
- •A fasting blood sugar level of 126 mg/dl and a random blood sugar level of less than 200 mg/dl
- •HbA1c (glycated haemoglobin) ≥ 6.5%
排除标准
- •Patients with systemic conditions other than type 2 diabetes
- •Women who are pregnant
- •Those patients that have used antibiotics within the previous three months,
- •Those patients that have teeth with developmental defects, calcified canals,
- •Teeth that cannot be isolated with rubber dams,
- •Tortuous canals
- •Roots that are fractured
研究组 & 干预措施
940 nm diode laser
it is used for disinfecting the canal
干预措施: Saline (NaCl) (Other)
Gymnema sylvestre
It is used as irrigating agent
干预措施: Diode laser and apple cider vinegar (Other)
940 diode laser and Apple cider vinegar
For disinfecting the canal
干预措施: Saline (NaCl) (Other)
Saline
Saline is used in the ideal conditions
干预措施: Diode laser and Gymnema Sylvestre (Other)
Saline
Saline is used in the ideal conditions
干预措施: Diode laser and apple cider vinegar (Other)
940 diode laser and Apple cider vinegar
For disinfecting the canal
干预措施: Diode laser and apple cider vinegar (Other)
Gymnema sylvestre
It is used as irrigating agent
干预措施: Gymnema Sylvestre (Other)
940 diode laser and Apple cider vinegar
For disinfecting the canal
干预措施: Gymnema Sylvestre (Other)
Saline
Saline is used in the ideal conditions
干预措施: Gymnema Sylvestre (Other)
940 diode laser and Gymnema sylvestre
For disinfecting the canal
干预措施: Gymnema Sylvestre (Other)
940 nm diode laser
it is used for disinfecting the canal
干预措施: Gymnema Sylvestre (Other)
Saline
Saline is used in the ideal conditions
干预措施: apple cider vinegar (Other)
940 nm diode laser
it is used for disinfecting the canal
干预措施: apple cider vinegar (Other)
Saline
Saline is used in the ideal conditions
干预措施: 940 nm diode laser (Other)
Saline
Saline is used in the ideal conditions
干预措施: Saline (NaCl) (Other)
940 diode laser and Apple cider vinegar
For disinfecting the canal
干预措施: apple cider vinegar (Other)
940 nm diode laser
it is used for disinfecting the canal
干预措施: 940 nm diode laser (Other)
940 nm diode laser
it is used for disinfecting the canal
干预措施: Diode laser and Gymnema Sylvestre (Other)
940 nm diode laser
it is used for disinfecting the canal
干预措施: Diode laser and apple cider vinegar (Other)
Apple cider vinegar
It is used as irrigating agent
干预措施: 940 nm diode laser (Other)
Apple cider vinegar
It is used as irrigating agent
干预措施: Saline (NaCl) (Other)
Apple cider vinegar
It is used as irrigating agent
干预措施: apple cider vinegar (Other)
Apple cider vinegar
It is used as irrigating agent
干预措施: Gymnema Sylvestre (Other)
Gymnema sylvestre
It is used as irrigating agent
干预措施: apple cider vinegar (Other)
Apple cider vinegar
It is used as irrigating agent
干预措施: Diode laser and Gymnema Sylvestre (Other)
Apple cider vinegar
It is used as irrigating agent
干预措施: Diode laser and apple cider vinegar (Other)
Gymnema sylvestre
It is used as irrigating agent
干预措施: 940 nm diode laser (Other)
Gymnema sylvestre
It is used as irrigating agent
干预措施: Saline (NaCl) (Other)
Gymnema sylvestre
It is used as irrigating agent
干预措施: Diode laser and Gymnema Sylvestre (Other)
940 diode laser and Apple cider vinegar
For disinfecting the canal
干预措施: 940 nm diode laser (Other)
940 diode laser and Apple cider vinegar
For disinfecting the canal
干预措施: Diode laser and Gymnema Sylvestre (Other)
940 diode laser and Gymnema sylvestre
For disinfecting the canal
干预措施: 940 nm diode laser (Other)
940 diode laser and Gymnema sylvestre
For disinfecting the canal
干预措施: Saline (NaCl) (Other)
940 diode laser and Gymnema sylvestre
For disinfecting the canal
干预措施: Diode laser and Gymnema Sylvestre (Other)
940 diode laser and Gymnema sylvestre
For disinfecting the canal
干预措施: Diode laser and apple cider vinegar (Other)
940 diode laser and Gymnema sylvestre
For disinfecting the canal
干预措施: apple cider vinegar (Other)
结局指标
主要结局
Visual analog scale
时间窗: 6 months
pain felt by the patients after the intervention 0- no pain -- better outcome 10- worst imaginable pain -- worst outcome
Detection of peptostreptococcus species after the use of intervention
时间窗: one year
Absence of peptostreptococcus species on PCR signifies disinfection of canal presence of peptostreptococcus species on PCR signifies irrigating agent is not effective
Visual Analog Scale (VAS)
时间窗: 6 months
A Visual Analog Scale is a validated, subjective, 1-dimensional tool used to measure intensity, most commonly pain. It consists of a 10-cm (100-mm) horizontal or vertical line, with endpoints anchored by extremes, such as "no pain" and "worst imaginable pain," with patients marking their level
次要结局
未报告次要终点
研究者
Dr Lakshmi Pandey
Associate professor
Sharda University