CTRI/2021/03/032326
Active, not recruiting
Phase 2
Clinical trial to evaluate the antimicrobial and antifungal efficacy of five oral hygiene products in healthy adult volunteers
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dabur India Limited
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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