Evaluation of Germ kill efficacy of 5 oral hygiene products

Clinical trial to evaluate the antimicrobial and antifungal efficacy of five oral hygiene products in healthy adult volunteers

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032326

Enrollment

150

Registered

2021-03-26

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

None listed

Interventions

Intervention1: Dabur Red Paste: Toothpaste- Single Use- One day intervention Intervention2: Dabur Red BAE gel: Toothpaste3- Single Use- One day intervention Intervention3: Dabur Dantrakshak: Toothpast

Eligibility

Inclusion criteria

Inclusion criteria: Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate Subjects of both genders in age group 18 â?? 65 years (both the ages inclusive). Subjects willing to give their swab samples for analysis. Subjects willing to follow 12 hr overnight gap of brushing/mouthwash and 4 hr fasting after brushing/mouthwash. Subjects willing to come for follow up visits at the specified time. Subjects ready to follow instructions during the study period . Subjects using toothpastes and mouthwash other than Dabur.

Exclusion criteria

Exclusion criteria: • A known history or present condition of hyper sensitivity to any toothpaste. • The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month. • Any history of periodontal therapy by surgical interventions. • Any history of dentine hypersensitivity treatment. • Orthodontic treatment with ï¬?xed appliances. • Any removable device such as a removable partial denture or orthodontic retainer. • The presence of any ï¬?xed appliance, large or defective restorations, cracked enamel, • History of smoking or smokeless tobacco products. • Subjects having moderate to severe dentine hypersensitivity. • Subjects having abnormal frenum attachment. • Subjects who are pregnant, lactating or nursing. • Subjects having severe level of calculus and/ tartar. • Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.

Design outcomes

Primary

Measure	Time frame
Reduction in germ count in percentage in comparison to baseline and control product.Timepoint: Before Brushing, After brushing (Immediately, 2hr and 4 hr)	—

Secondary

Measure	Time frame
Reduction in specific germ counts in selected groups as compared to baseline and control product.Timepoint: Before Brushing, After brushing (Immediately, 2hr and 4 hr)	—

Countries

India

Contacts

Public ContactMs Ritambhara

Dabur India Limited

vedula.sasibhushan@dabur.com01203368614

Outcome results