Health Condition 1: K056- Periodontal disease, unspecified
Conditions
Interventions
Intervention1: MNDV toothpaste: 4 weeks clinical study to evaluate the efficacy and safety of Herbs & More Herbal Dental Paste in dental care of healthy adults
Control Intervention1: Nil: Nil
Sponsors
MN Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Age: 18 to 55 years (both inclusive) at the time of consent. Sex: Healthy male or non-pregnant/non-lactating females. Females of Childbearing potential must have a negative urine pregnancy test performed on screening and enrollment visit. Subjects are in good general health as determined by the Investigator on the basis of medical history. Subjects having T-VSC reading (total volatile sulphur compounds) of >160 ppb (parts per billion) Subjects with mild, moderate and severe plaque with plaque index 2-4. Subjects with mild to moderate gingivitis with modified gingival index 0.1-0.3. Subjects should be willing to come to the test site without brushing their teeth in the morning. Subjects should be willing to not to consume anything except water after meal of previous night. Subjects must be able to understand and provide written informed consent to participate in the study. Subjects should be willing and able to follow the study directions to participate in the study.
Exclusion criteria
Exclusion criteria: Subjects with orthodontic bands. Subjects with plaque index of 0, 1 and 5 Subjects with partial removable dentures. Subjects having tumor(s) of the soft or hard tissues of the oral cavity. Subjects with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) Subjects having carious lesion which requires immediate restorative treatment. Subjects having used antibiotics anytime during the last three months prior to entry into the study. Subjects having participated in any other dental clinical study within last six months prior to entry into the study. Subjects with dental prophylaxis during the past two weeks prior to baseline examinations. Subjects with history of allergies to any oral care/personal care consumer products or their ingredients. Subjects on any prescription medicines that might interfere with the study outcome. Subjects taking oral contraceptives and other medication based contraceptives. Pregnant female subjects or female planning to get pregnant during study duration. Consumption of any medicated sweets, chewing gum, breath fresheners etc. containing antimicrobial agents. Subjects with diseases or having history that potentially can contribute to oral malodor (e.g. diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.) Subjects that consume alcohol. Subjects that smoke cigarette or consume any other form of tobacco.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of test product for reduction in gingivitis (inflammation of gums) & to evaluate gum tightening by dental examination using modified gingival index.Timepoint: From baseline to end of study ie day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of test product on malodor control using Halimeter. To evaluate the effect of test product for plaque reduction using plaque index To evaluate the effect of test product for reduction in gingival bleeding using modified sulcular bleeding index. To evaluate the effect of test product on carious teeth by visual assessment by dentist. To evaluate test product efficacy and tolerance via questionnaires as stated in Appendix III & IV. Timepoint: screening visit (Within -30 Days prior to Day 1) and enrollment (Day 1), evaluation (Day 15 ± 2days) and evaluation/end of study (Day 30 ± 2days) | — |
Countries
India
Contacts
Public ContactMr Ashish Nagaonkar
Mprex Healthcare
Outcome results
None listed