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Evaluation of efficacy and safety of Dabur Ayurtejas dental paste

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008054
Enrollment
40
Registered
2017-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K051- Chronic gingivitis Health Condition 2: K029- Dental caries, unspecified Health Condition 3: R196- Halitosis

Interventions

Intervention1: Dabur Ayurtejas Dental Paste: Dabur Ayurtejas Dental Paste is a polyherbal mixture of 34 herbs and 1 herb-omineral ingredients will be requested to use full length brush amount (2-2.5 g

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 �xed appliances. 6. The presence of any �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.

Design outcomes

Primary

MeasureTime frame
1. Reduction in gingivitis in comparison to baseline. 2. Reduction of plaque in comparison to baseline. Timepoint: 12 weeks

Secondary

MeasureTime frame
1. Reduction of plaque, halitosis, dental staining and in improvement of overall oral hygiene in comparison to baseline. 2. Strengthening of teeth and gums. 3. Significant reduction of gum bleeding and gum pain. 4. Prevention of teeth from further aggravation of dental caries after TP usage of 3 months. 5. Control in tooth erosion after TP usage. 6. Protecting teeth from germs 7. Whitening of teeth 8. Safety for gingival, oral mucosa and lips. Timepoint: 12 weeks

Countries

India

Contacts

Public ContactRitambhara

Dabur India limited

arun.gupta@dabur.com919910200255

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026