CTRI/2021/07/034750
Completed
Phase 2
Clinical study to evaluate the efficacy and safety of an oral care product on oral malodour reduction and its causative microflora in healthy adult subjects
ConditionsHealth Condition 1: R196- Halitosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: R196- Halitosis
- Sponsor
- Dabur India limited
- Enrollment
- 161
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ã¢â?¬Â¢Having at least 16 natural, permanent teeth.
- •Ã¢â?¬Â¢Subjects with bad oral hygiene and halitosis (self\-reported or clinically diagnose). Subjects who have plague and dental caries.
- •Ã¢â?¬Â¢Subjects willing to give their swab samples for analysis.
- •Ã¢â?¬Â¢Subjects willing to follow 12 hr. overnight gap of brushing/mouthwash and 4 hr. fasting after brushing on day 30 assessment.
- •Ã¢â?¬Â¢Subjects willing to come for follow up visits at the specified time.
- •Ã¢â?¬Â¢Subjects ready to follow instructions during the study period.
- •Ã¢â?¬Â¢Subjects who use oral hygiene products other than Dabur.
- •Ã¢â?¬Â¢Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
Exclusion Criteria
- •Ã¢â?¬Â¢A known history or present condition of hyper sensitivity to any toothpaste.
- •Ã¢â?¬Â¢The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
- •Ã¢â?¬Â¢Any history of periodontal therapy by surgical interventions.
- •Ã¢â?¬Â¢Any history of dentine hypersensitivity treatment. Subjects having moderate to severe dentine hypersensitivity.
- •Ã¢â?¬Â¢Orthodontic treatment with ï¬?xed appliances.
- •Ã¢â?¬Â¢Any removable device such as a removable partial denture or orthodontic retainer.
- •Ã¢â?¬Â¢The presence of any ï¬?xed appliance, large or defective restorations, cracked enamel,
- •Ã¢â?¬Â¢History of smoking or use of smokeless tobacco products.
- •Ã¢â?¬Â¢Subjects having moderate to severe dentine hypersensitivity.
- •Ã¢â?¬Â¢Subjects having abnormal frenum attachment.
Outcomes
Primary Outcomes
Not specified
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