Health Condition 1: K036- Deposits [accretions] on teeth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 . Systemically healthy adult subjects in the age group of 18-60 years who require oral hygiene support for maintaining or improving periodontal health and who agree to comply with the study procedures. 2. Subjects having gingival probing depth of less than 3mm. 3.Subjects having gingival index scores of equal to 2 and in more than 10 percent of the sites 4.Subjects with no history of hypersensitivity reactions. 5.Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 6. Subjects should not have history of periodontal therapy one 7.Subjects having plaque index scores of equal to 2 and in more than 10percent of the sites
Exclusion criteria
Exclusion criteria: 1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures; 2. Subjects with chronic or aggressive periodontitis; 3. Subjects with history of oral antibiotic prophylaxis within the past 1 month; 4.Tobacco consumers and smokers, 5.Subjects who are on any antibiotic therapy for the past 1 month and subjects with any other medical history that could compromise the conduct of the study 6.Subjects who are pregnant or lactating. 7.Subjects with previous history of any allergic reactions to the test products 8. Subjects participating in concomitant interventional clinical study during the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plaque Index (PI) and Modified Gingival Index (MGI) from baseline to end of study 2. To assess percentage mean reduction CFUs in cariogenic oral microflora (S.mutans) from baseline to end of study. 3. To assess percentage mean reduction CFUs in below species of gram positive from baseline to end of study. (Streptococcus mutans, Streptococcus sobrinus, Streptococcus anginosus, Lactobacillus spp) 4.To assess percentage mean reduction CFUs in fungus from baseline to end of study. 5.Effect of test product in reducing the Cavities 6.Effect of test product in reducing Halitosis 7.Effect of test product in reducing bleeding gums 8.To assess percentage mean reduction CFUs in below gram negative from baseline to end of study. (Porphyromonas gingivalis, Fusobacterium nucleatum,Prevotella intermedia) Timepoint: Baseline , Week 4 and Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess improvement in Clinical Oral Dryness Score (CODS) from baseline to end of study. 2. To assess improvement in Organoleptic Scoring Scale (OSS) from baseline to end of study. 3.To assess improvement in VITA Shade Scale from baseline to end of study. 4.To assess the safety of test product throughout the study period by monitoring for any adverse events during the study period of 8 weeks.Timepoint: Baseline, week 4 and week 8 | — |
Countries
India
Contacts
Ki3 Private Limited