A Double blind, randomized, placebo controlled, clinical study to evaluate the efficacy of a Dabur Babool Neem Toothpaste DRDC/PC/8003 in oral hygeine and dental care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- For GIngivitis & Periodontitis Group:
研究概览
简要总结
This is a single centerd, Double Blind; Placebo Controlled; randomized, clinical study to evaluate the efficacy of a Dabur Babool Neem Toothpaste in oral Hygiene and Dental Care. 50 subjects were enrolled in the study on the basis of two groups one group is diseased group having Gingivitis and Periodontitis and 20 Healthy Volunteers were enrolled in other group. For Gingivitis and Periodontitis group Duration of the study was 12 weeks of use of product and one week follow up where as in Healthy group duration of study was 6 weeks of use of product.Subjects were assessed on various parameters like: Change in pH of saliva,change in pH of gingival crevicular fluid,change in gingival crevicular flow,reduction in microbial counts (swab culture)change in malodor,change in stain score,change in gingival index,change in plaque scores,change in clinical attachment loss scores,global patient evaluation,global physical evaluation,Adverse Reactions/Adverse Events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Periodontitis & Gingival Group:
- •Subjects of both sexes in the age groups of 18-45 yrs
- •Subjects willing to sign informed consent form
- •Subjects who have at least 20 natural uncrowned teeth excluding third molars.
- •Subjects with periodontitis and gingivitis
- •Subjects with ability to comply with all study requirements.
- •Subjects having gingivitis with gingival index > 1 at more than 60 % of sites examined.
- •Subjects with tooth stains.
- •Subjects having dental plaque with plaque index of 2 or more.
- •Healthy Group:
- •Healthy subjects of both sexes in the age group of 18 to 45 years.
排除标准
- •Periodontitis & Gingival Group:
- •Subjects having pain and multiplicity of periodontal/gingival problems or advanced generalized chronic inflammatory periodontal disease or any gross oral pathology.
- •Subjects having history of known sensitivity or oral mucosal tissue reaction to toothpaste.
- •Subjects having any serious systemic disease.
- •Subjects with any external dental treatment like scaling, polishing, flossing etc.
- •Subjects with Upper respiratory tract infection, Urinary tract infection, Gastrointestinal Tract infection, Skin infection.
- •Subjects with history of intake of antibiotics and anti-inflammatory drugs for the past 3-4 weeks
- •Subjects with history of fluoride treatment for the past two weeks.
- •Pregnant or lactating mothers.
- •Subjects with involvement in any concurrent study the nature of which may affect the parameters being investigated in the study.
- •Subjects not willing to sign informed consent.
- •Subjects not willing to come for follow-up when required
- •Subjects with presence of relatively severe tetracycline stained teeth.
- •Healthy Group: As per the exclusion criteria for gingivitis & periodontitis group.
结局指标
主要结局
For GIngivitis & Periodontitis Group:
时间窗: 12 weeks for gingivits & periodontitis group & 6 weeks for healthy group
change in scores of gingivitis &/or signs & symptoms, change in microbiologiacl assesment (swab culture), elimination/reduction in malodor if applicable, change in scores of lobene stain &/or signs & symptoms, change in plaque scores &/or signs & symptoms, change in clinivcal attachement loss
时间窗: 12 weeks for gingivits & periodontitis group & 6 weeks for healthy group
For Healthy Group:
时间窗: 12 weeks for gingivits & periodontitis group & 6 weeks for healthy group
Reduction in microbial counts (swab culture)
时间窗: 12 weeks for gingivits & periodontitis group & 6 weeks for healthy group
次要结局
- For GIngivitis & Periodontitis Group:(Global patient & Investigator evaluation, ADR/AE profile)