Health Condition 1: R196- Halitosis
Conditions
Interventions
Intervention1: Gel toothpaste: 2-3 gm for brushing twice a day for 30 days
Control Intervention1: Marketed comparator: 2-3 gm for brushing twice a a day for 30 days
Sponsors
Dabur India limited
Eligibility
Inclusion criteria
Inclusion criteria: � Having at least 16 natural, permanent teeth. � Subjects with bad oral hygiene and halitosis (self-reported or clinically diagnose). Subjects who have plague and dental caries. � 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 on day 30 assessment. � Subjects willing to come for follow up visits at the specified time. � Subjects ready to follow instructions during the study period. � Subjects who use oral hygiene products other than Dabur. � Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
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. Subjects having moderate to severe dentine hypersensitivity. � Orthodontic treatment with �xed appliances. � Any removable device such as a removable partial denture or orthodontic retainer. � The presence of any �xed appliance, large or defective restorations, cracked enamel, � History of smoking or use of 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 |
|---|---|
| ââ?¬Â¢ Significant reduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator. ââ?¬Â¢ Significant reduction in malodour by Oral Chroma assessment at various time points in comparison to the baseline and with comparator. ââ?¬Â¢ Significant reduction (X%) in oral microflora with product use and with comparator. Timepoint: Day 1-T0,Timm, Day30-T0, Timm, T4hr and T12hr | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢Significant reduction in plaque, gingivitis, bleeding index and oral hygiene index with regular use of test product at various time points in comparison to the baseline and with comparator. Timepoint: Day1-T0,Timm, Day30-T0,Timm | — |
Countries
India
Contacts
Public ContactMs Ritambhara
Dabur India Limited
Outcome results
None listed