An open label, single arm, monocentric clinical study to evaluate of efficacy and safety of Dabur Ayurtejas dental paste

Dabur India Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects with age group 18-65 years in general good health.
•2. Subjects with mild, moderate and severe gingivitis.
•3. Subjects having ICADS score of 1 â?? 4 concerning dental caries. Any ICDAS score of above 4 for particular tooth/teeth will not be considered for the evaluation.
•4. Subjects having extrinsic dental stains and bad oral hygiene.
•5. Minimum of 20 natural uncrowned teeth (excluding 3rd molars) must be present.
•6. No history of allergy to oral care consumer product specifically ingredients of tooth paste.
•7. Subjects willing to give a voluntary written informed consent for photography release and agree to come for regular follow up.
•8. Subjects willing to abide by and comply with the study protocol.
•9. Subjects who have not participated in a similar investigation in the past four weeks.
•10. Subjects who are ready to be available for the entire duration of the study.
•11. Subjects who are willing not to participate in any other clinical study during participation in the current study.

•1. A known history or present condition of hyper sensitivity to any tooth paste.
•2. The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during previous 1 month.
•3. Moderate to severe periodontal condition.
•4. Any periodontal therapy by surgical interventions along with medications during previous 1 month.
•5. Orthodontic treatment with ï¬?xed appliances.
•6. The presence of any ï¬?xed appliance, large or defective restorations, cracked enamel, or caries on the history hypersensitive tooth.
•7. Subjects consuming smokeless tobacco products.
•8. Subjects having moderate to severe dentine hypersensitivity.
•9. Subjects having intrinsic dental stains.
•10. Subjects who have had any treatment which may interfere the dental evaluation.
•11. Subjects having abnormal frenum attachment.
•12. Significant decreased salivary flow.
•13. Any uncontrolled medical illness including diabetes mellitus, hypertension, liver disease, HIV, hepatitis, or any other serious medical illness.

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