Antimicrobial Efficacy of 810nm Diode Laser on S. Mutans in Caries Susceptible Children of age 4-6 years
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Reduction of S. mutans count in plaque and saliva using single and double irradiation by Antimicrobial Photodynamic Therapy
研究概览
简要总结
This Study involves the use of a diode laser and photosensitizer to observe the decrease in S.mutans CFU in plaque and saliva after single and double irradiation in 4- 6 years children, where aPDT effect will be observed in both single and double irradiation with and without photosensitizer. Plaque and salivary samples will be collected and transferred to agar media and their CFU will be counted.
1st visit – pre-operative samples ( plaque and saliva) will be taken for all groups & immediate post-operative samples will be collected after being subjected to respective light therapy protocols in all the groups.
2nd visit – after 24 hours, post-operative samples will be collected in all groups.
3rd visit –In double irradiation groups (groups -3,4) on the 3rd day pre-operative & immediate post-operative plaque samples will be collected after the 2nd dose of light therapy.
4th visit – After 1 week, post-operative plaque samples and salivary samples will be collected in all groups.
5th visit – After 2 weeks, post-operative plaque samples and salivary samples will be collected in all groups.
6th & 7th visits - recording of the caries incidence at 3 & 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •urban population of low socioeconomic class 2)Improper brushing habits 3)Plaque scores- 2&3 4)Sweet scores: 10 & 15 5)S.
- •mutans microbial count of 100000CFU/ml 6)salivary pH of less than 5.5 7)stimulated salivary flow rate of 0.7ml/min 8)unstimulated salivary flow rate of 0.3ml/min 9)salivary viscosity mucous.
排除标准
- •1.Children with systemic disorder 2.Children with low plaque scores 3.Children who had undergone prophylaxis procedures in last few weeks 4.Children who are under medication (antibiotics) in last two weeks / 1month.
结局指标
主要结局
Reduction of S. mutans count in plaque and saliva using single and double irradiation by Antimicrobial Photodynamic Therapy
时间窗: 1)single irradiation group - Baseline, 0 min, 24 hours, 7th day and 14th day | 2)double irradiation groups - Baseline, 0 min, 24 hours,3rd day, 7th day and 14th day
次要结局
- b)Caries incidence is evaluated at 3 & 6 months using Nyvad’s criteria.(at 3 and 6 months)
研究者
Dr Mandala Pravallika
Vishnu Dental College