An open label, single arm, monocentric clinical study to evaluate of efficacy and safety of Dabur Ayurtejas dental paste
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Reduction in gingivitis in comparison to baseline.
研究概览
简要总结
Adult subjects of either sex with age between 18-65 years (both inclusive) will be screened for eligibility criteria. On screening visit a written informed consent will be obtained from the subject. Assessment of inclusion and exclusion criteria will be done including dental & systemic parameters, Subject will be trained on brushing technique and filling of subject diary. After that subject will be given 100 gm of Dabur Ayurtejas Dental Paste, a soft bristle, toothbrush and subject diary. Subject will be asked to brush two times a day (Morning & Evening). Subjects will be asked to follow up at week 2, 4, 8 & 12 (End of study). At each follow up and end of study visit, subject’s dental & general examination along with parameters as mentioned in appendix 2a will be performed. At every visit, compliance check regarding IP usages and filling of subject diary will be done. IP will be replenished at each and a new brush will be dispensed at week 4. At the end of the study, all used and unused IP will be retrieved and study exit form will be filled up. Adverse events will be recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with age group 18-65 years in general good health.
- •Subjects with mild, moderate and severe gingivitis.
- •Subjects having ICADS score of 1 – 4 concerning dental caries.
- •Any ICDAS score of above 4 for particular tooth/teeth will not be considered for the evaluation.
- •Subjects having extrinsic dental stains and bad oral hygiene.
- •Minimum of 20 natural uncrowned teeth (excluding 3rd molars) must be present.
- •No history of allergy to oral care consumer product specifically ingredients of tooth paste.
- •Subjects willing to give a voluntary written informed consent for photography release and agree to come for regular follow up.
- •Subjects willing to abide by and comply with the study protocol.
- •Subjects who have not participated in a similar investigation in the past four weeks.
- •Subjects who are ready to be available for the entire duration of the study.
- •Subjects who are willing not to participate in any other clinical study during participation in the current study.
排除标准
- •A known history or present condition of hyper sensitivity to any tooth paste.
- •The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during previous 1 month.
- •Moderate to severe periodontal condition.
- •Any periodontal therapy by surgical interventions along with medications during previous 1 month.
- •Orthodontic treatment with ï¬xed appliances.
- •The presence of any ï¬xed appliance, large or defective restorations, cracked enamel, or caries on the history hypersensitive tooth.
- •Subjects consuming smokeless tobacco products.
- •Subjects having moderate to severe dentine hypersensitivity.
- •Subjects having intrinsic dental stains.
- •Subjects who have had any treatment which may interfere the dental evaluation.
- •Significant decreased salivary flow.
- •Any uncontrolled medical illness including diabetes mellitus, hypertension, liver disease, HIV, hepatitis, or any other serious medical illness.
结局指标
主要结局
1. Reduction in gingivitis in comparison to baseline.
时间窗: 12 weeks
2. Reduction of plaque in comparison to baseline.
时间窗: 12 weeks
次要结局
- 1. Reduction of plaque, halitosis, dental staining and in improvement of overall oral hygiene in comparison to baseline.(2. Strengthening of teeth and gums.)