Efficacy of Gum Forte Gel Homoeopathic Toothpaste on Stage 1- Grade B periodontitis patients: A single center, randomized controlled clinical trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of
研究概览
简要总结
The study will be initiated after obtaining written approval from the ethics
committees Patients in all age group with periodontitis will be enrolled if they
provide written informed consent and satisfy eligibility criteria and negative
for all exclusion criteria. Demographic medical history comorbidities and
other relevant clinical details will be recorded at baseline Patients will
undergo standard care as per routine practice and periodontal guideline
All participants who are diagnosed as Stage 1 - Grade B periodontitis will be enrolled in treatment group
Subjects will use their regular toothpaste as standard of care in control group.
Inclusion criteria:
Homoeopathic Toothpaste after their dental checkup baseline scaling Root
planning and microbiological examination
During in person visits Periodontal parameters microbial examination and
clinical features will be done along with recording AEs concomitant
medications and treatment compliance from baseline till the study duration
After clinical assessments, General consultation will be done. The parameters
and outcomes will be assessed at 4 and 12 weeks along with refilling their
medication with monitoring their adherence to their respective treatment
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults 18 to 60 years Clinical diagnosis of Stage 1 Grade B periodontitis Ability to provide informed consent and comply with study protocols till the end Intent to develop the habits of cleaning teeth twice a day with flat end soft bristles toothbrush as mentioned PPD 4mm CAL 1 2mm.
排除标准
- •Patients on anticoagulants therapy Habit of smoking or Chewing tobacco Patients with the history of antibiotic prophylaxis with in the past 1 month Patients who underwent scaling with in the past 1 month Patients undergoing orthodontic treatments Pregnant and lactating women.
结局指标
主要结局
To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
periodontitis measured by bleeding on probing BOP probing pocket
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
depth PPD Clinical attachment level CAL periodontal inflamed
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
surface area PISA Gingival index simplified OHI plaque index and
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
comprehensive periodontal examination
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
the help of Microbiologist
时间窗: To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of | periodontitis measured by bleeding on probing BOP probing pocket | depth PPD Clinical attachment level CAL periodontal inflamed | surface area PISA Gingival index simplified OHI plaque index and | comprehensive periodontal examination | To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with | the help of Microbiologist
次要结局
- To evaluate the oral health related quality of life by oral health quality of(life index questionnaire OHRQoL)
研究者
Dr Divya Kumar
Sri Ramachandra Institute of Higher Education and Research