Health Condition 1: K039- Disease of hard tissues of teeth,unspecified
Conditions
Interventions
Intervention1: Gurunanda Coco- Mint Oil Pulling Oral Rinse: Caprylic/Capric/Lauric Triglycerides, Peppermint Oil,
Spearmint Oil, Clove Oil, Cardamom oil, Tea Tree Oil, Stevia Leaf
Extract, Oregano oil
Sponsors
GuruNanda LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1.who prefer to improve teeth shade cosmetically and who would want to maintain oral hygiene and to comply with the study procedures. 2.Tooth shade A2 or darker. 3.Good general health with no systemic conditions affecting oral health. 4.Presence of natural teeth with visible extrinsic stains or discoloration. 5.Willingness to avoid other whitening treatments during the study period. 6.Ability to provide informed consent. 7.Compliance with study protocols, including scheduled visits and post-treatment care. 8.Not wearing a clear aligner, retainer, and night guard
Exclusion criteria
Exclusion criteria: 1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures. 2.Subjects with chronic or aggressive periodontitis who underwent recent whitening intervention. 3.Tobacco consumers and smokers, betel chewers. 4.Subjects who are pregnant or lactating. 5.Subjects with hypersensitivity to any of the test products. 6.Subjects with pre-existing tooth sensitivity. 7.Concurrent use of any other treatment for teeth whitening or sensitivity. 8.Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment. 9.Severe enamel defects or intrinsic discoloration unrelated to staining. 10.Prior participation in a similar study within the past six months. 11.Current use of medications causing tooth discoloration, such as tetracycline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess improvement in VITA shade scale over various assessments. 2.Air Blast Hypersensitivity. 3.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air(Constant stimulus on the basis of duration, pressure, temperature and distance from target).Response is rated on the Schiff cold Air sensitivity Scale. 4.To observe the Enamel by Visual Inspection 5.To observe the Enamel by Tactile Examination using dental probes, the dentist can feel the texture of the enamel by Mohs hardness scale. 6.Picture of pre and post assessment will be taken.Timepoint: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of the investigational product throughout the study period for any abnormal findings on gingival and mucosal tissues, dental hard tissues, including but not limited to the gingiva (free and attached), hard and soft palate, oropharynx/uvula, buccal mucosa, tongue, floor of the mouth, labial mucosa, mucobuccal/mucolabial folds, lips, and perioral area.Timepoint: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6);Additionally, the oral hard tissues will be assessed and abnormal finding questionnaire: burning mouth, altered taste, sore mouth, ulcers, change in gum colours, sensitivity etc.Timepoint: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6) | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
KI3 PRIVATE LIMITED
Outcome results
None listed