Health Condition 1: K050- Acute gingivitis Health Condition 2: K036- Deposits [accretions] on teeth
Conditions
Interventions
None listed
Sponsors
Maharishi Ayurveda Products Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 55 years. 2. Able and willing to provide written informed consent. 3. Subjects with mild to moderate dental hypersensitivity (self-reported or clinically confirmed). 4. Subjects with de ntal plaque (Plaque Inde x greater than equal to 2) at screening. 5. Subjects in generally good health and considered by the Investigator capable of complying with study procedures and scheduled visits. 6. Willingness to refrain from use of any other toothpaste, mouthwash, or oral hygiene products during the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Subjects with significant oral pathology, including: - Advanced generalized chronic inflammatory periodontal disease - Gross oral pathology (e.g., tumors, soft tissue lesions) - Carious lesions requiring immediate restorative treatment 3. Subjects with orthodontic appliances, or more than one incisor with prosthetic crown/veneer. 4. Subjects with moderate to advanced periodontal disease. 5. History of oral tumors or significant pathology of hard or soft tissues of the oral cavity. 6. Any systemic illness or condition that may interfere with the Investigator s interpretation of study outcomes. 7. Participation in another clinical drug/device trial within 3 months prior to recruitment. 8. Known allergy or hypersensitivity to any of the ingredients in the investigational product or placebo formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Salivary pH balance measured at 0 hour and 12 hour, both pre- and post-brushing, to evaluate the maintenance of optimal pH levels throughout the day. 2. Saliva quality parameters, including: - Salivary calcium levels - Salivary phosphate levels - Buffering capacity of unstimulated and stimulated saliva (bicarbonate concentration) - Salivary amylase - Salivary lactate dehydrogenase (LDH) 3. Cleansing effect of saliva in fighting germs up to 12 hours, as determined by microbial swab culture.Timepoint: Visit 1-Day 0 Visit 2-Day 15 3 Days Visit 3-Day 30 3 Days Telephonic Follow up visit-Day 45 3 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Enamel erosion protection, evaluated through dentist visual assessment and enamel erosion score. 2. Reduction in tooth sensitivity and gum discomfort, assessed by Visual Analogue Scale (VAS). 3. Improvement in teeth whiteness, assessed by dentist visual evaluation from baseline to end of study. 4. Breath freshness (anti-halitosis), evaluated for up to 12 hours using a patient self-reported scale. 5. Relief in toothache (within 24 hours), assessed by Visual Analogue Scale (VAS). 6. Reduction in dental plaque, assessed by Plaque Index (PI). 7. Reduction in gingivitis and gum inflammation, and gum tightening, evaluated using Modified Gingival Index (MGI). 8. Assess the changes in perceived stress and its correlation with overall dental health during the trial period. 9. Overall dental health, evaluated using Dentist Global Assessment (DGA) questionnaireTimepoint: Visit 1-Day 0 Visit 2-Day 15 3 Days Visit 3- Day 30 3 Days Telephonic Follow up visit-Day 45 3 Days | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed