None listed
Conditions
Interventions
None listed
Sponsors
Ayubal Wellness Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age Range: Individuals aged 13 to 70 years. 2.Oral Health Status: Participants with mild to moderate gingivitis, plaque accumulation, or dental sensitivity. 3.Oral Hygiene Practices: Willingness to use Akayu Dantvam as the sole oral care product during the study period. 4.Informed Consent: Ability and willingness to provide written informed consent (for minors, consent must be obtained from a parent or guardian). 5.Compliance: Ability and willingness to comply with all study procedures and visits.
Exclusion criteria
Exclusion criteria: 1.Severe Oral Conditions: Presence of severe periodontal disease, severe dental caries, or other significant oral pathologies that may interfere with the study. 2.Recent Dental Procedures: Participants who have undergone major dental procedures (such as extractions, implants, or periodontal surgery) within the last three months. 3.Systemic Conditions: Presence of systemic conditions or diseases that affect oral health (e.g., uncontrolled diabetes, immunocompromised status). 4.Allergies: Known allergy or hypersensitivity to any component of Akayu Dantvam. 5.Concurrent Participation: Participation in another clinical trial within the last 30 days or current participation in another clinical study. 6.Pregnancy or Lactation: Pregnant or lactating women. 7.Non-compliance: Any condition or situation that, in the investigator’s opinion, may interfere with the participant’s ability to comply with the study requirements or pose a risk to their safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction in Sensitivity to Hot and Cold: Measurement Tool: Visual Analog Scale. Description: Assessment of changes in dental sensitivity to thermal stimuli (hot and cold) as reported by participants. 2.Reduction in Plaque Accumulation: Measurement Tool: Plaque Index or Modified Quigley-Hein Plaque Index (MQHPI). Description: Evaluation of the amount of dental plaque on tooth surfaces before and after using Akayu Dantvam. 3.Decrease in Gingival Bleeding: Measurement Tool: Gingival Bleeding Index. Description: Measurement of the extent of gingival bleeding as an indicator of gingival health and inflammation. 4.Elimination of Halitosis: Measurement Tools: Organoleptic assessment and patient-reported outcomes. Description: Evaluation of the presence and severity of bad breath before and after using Akayu Dantvam. Timepoint: Day 0, Day 14 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in Gum Swelling. 2. Prevention of Tooth Loosening. 3. Incidence of Cavities. 4. Improvement in Toothache Severity. 5. Prevention of Tooth Discoloration. Timepoint: Day 0, Day 14 and Day 30 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed