Health Condition 1: K088- Other specified disorders of teethand supporting structures
Conditions
Interventions
Intervention1: Gurunanda Oil Pulling Oral Rinse with Ashwagandha & Neem: Caprylic/Capric/Lauric Triglyceride, Cinnamon Oil, Ashwagandha Extract, Clove Oil, Cardamom Oil, Tea Tree Oil, Turmeric Extract
Sponsors
Gurunanda LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 50 years. 2. Presence of a minimum of 20 teeth. 3.Presence of tooth sensitivity (index of the intensity of teeth hyperesthesia, IIGZ score greater than 2). 4.Adequate oral hygiene and no signs of oral neglect. 5. Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale. 6. Use of a non-desensitizing dentifrice for one month prior to entry into the study. Participant is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study 7.
Exclusion criteria
Exclusion criteria: 1. Professional teeth cleaning and whitening less than 30 days before the examination. 2. Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study, or the need to carry out them during the study period. 3. The use of analgesic agents less than 7 days prior to inclusion. 4. Untreated dental caries or active periodontal disease 5. Presence of cracked, chipped, or fractured teeth. 6. Severe enamel loss, dentin exposure, or pulpitis 7. Teeth whitening, scaling, or polishing within the past 4 6 weeks. 8. Recent restorations or oral surgeries that could influence sensitivity. 9. Regular use of desensitizing toothpaste or treatments within the past 4 weeks 10. Use of prescription fluoride treatments or other dental products specifically targeting sensitivity 11. Conditions affecting oral health, such as diabetes, Sj gren s syndrome, or GERD 12. Excessive consumption of acidic foods or beverages 13. Heavy tobacco or alcohol use that could affect oral health or study results. 14. History of bruxism, clenching, or other habits that could increase tooth wear. 15. Known allergies to any components of the products being tested. 16. Conditions or medications that might interfere with the perception of sensitivity (e.g., pain medications) 17. Participation in any other clinical study or test panel within one month prior to entry into the study. 18. History of Hepatitis B or C, HIV infection. 19. Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study 20. Pregnant or lactating participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ) will be used 2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain in the samples, where the values from 1 to 3 corresponded to the light intensity of pain, from 4 to 6 points - moderate, and 7 or higher strong 3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S) [ Time Frame: Baseline to 4 weeks] 4. Air Blast Hypersensitivity [ during each visit over 1-4 weeks] 5. Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus based on duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale. 6. Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity. 7. Photographic AssessmentTimepoint: Baseline,Week 1, Week 2 , Week 3 and Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant and Investigator Feedback will be obtained before enrollment and after completion of the study Adverse event monitoringTimepoint: Baseline,Week 1, Week 2 , Week 3 and Week 4 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
KI3 PRIVATE LIMITED
Outcome results
None listed