None listed
Conditions
Interventions
Intervention1: Zugu Oral Rinse Liquid Toothpaste: Use 8 to 10 ml of Zugu Oral Rinse Liquid Toothpaste in the morning and evening, swish in mouth thoroughly for one minute, expel out and rinse
mouth w
Sponsors
Ruba Ventures Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years (both inclusive) at the time of consent.2) Sex: Healthy male and non-pregnant/non-lactating females.3) Females of childbearing potential must have a negative urine pregnancy test performed on screening.4) Subjects are in good general health as determined by the Investigator on the basis of medical history.5) Subjects having clinically relevant mouth malodor evident by Halimeter.6) Subjects with mild and moderate plaque with plaque index 2-4.7) Subjects with mild to moderate gingivitis with modified gingival index 0.1-2.0.8) Subjects should be willing to come to the study site without brushing their teeth in the morning for visit 1, visit 2, and visit 3.9) Subject willing to stay at study center for 6 hrs on visit 1, visit 2, and visit 3.10) Subjects should be willing to not consume anything except water after the meal of previous night.11) Subjects must be able to understand and provide written informed consent to participate in the study.12) Subjects should be willing and able to follow the study directions to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subjects with orthodontic bands. 2) Subjects with plaque index of 0, 1 and 5 3) Subjects with partial removable dentures. 4) Subjects having tumor(s) of the soft or hard tissues of the oral cavity. 5) Subjects with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) 6) Subjects with a history of drug-induced tooth discoloration. 7) Subjects having carious lesion which requires immediate restorative treatment. 8) Subjects with ongoing antibiotic treatment at the time of screening. 9) Subjects having participated in any other dental clinical study within the last six months prior to entry into the study. 10) Subjects with dental prophylaxis during the past two weeks prior to baseline examinations. 11) Subjects with a history of allergies to any oral care/personal care consumer products or their ingredients. 12) Subjects on any prescription medicines that might interfere with the study outcome. 13) Pregnant and lactating women. 14) Subjects habitual to consumption of any medicated sweets, chewing gum, breath fresheners, etc. containing antimicrobial agents. 15) Subjects with diseases or having a history that potentially can contribute to oral malodor (e.g. diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.) 16) Subjects habitual of consumption of alcohol, tobacco, and smoking cigarettes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the antiplaque efficacy of Zugu Oral Rinse Liquid Toothpaste by evaluating the effect in plaque reduction (for measuring layer formation by the microorganisms on teeth) using plaque index on screening & end of the study. 2. To assess the anti-gingivitis efficacy of Zugu Oral Rinse Liquid Toothpaste by evaluating the effect in reduction of gingivitis using modified gingival index on screening & end of the study.Timepoint: Screening, Baseline, Day 15 & Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of the test product on malodor control using a Halimeter from screening to end of the study. 2. Changes in subject-reported freshness score on 5-point scale from screening to end of the study. 3. Changes in dentist-reported visual teeth whiteness assessment score on screening & end of the study. 4. To assess the potential of Zugu Oral Rinse Liquid Toothpaste as an alternative to toothpaste on 4 points Linkert scale by the investigator and subjects [Strongly disagree (1), disagree (2), neutral (3), agree (4), strongly agree (5)] from baseline to end of the study. 5. To evaluate the effect of the test product on carious teeth by visual assessment by the dentist on screening and end of the study. 6. To evaluate the effect of test product for reduction in gingival bleeding using modified sulcular bleeding index on screening and end of the study.Timepoint: Screening, Baseline, Day 15 & Day 30 | — |
Countries
India
Contacts
Public ContactMr N Sugumar
Ruba Ventures Private Limited
Outcome results
None listed