Health Condition 1: K051- Chronic gingivitis
Conditions
Interventions
Intervention1: GuruNanda Advance Formula Pulling Oil: Dose: 15 ml (in a measuring cup) twice a day before brushing(once in morning and second at before sleep)
Rout:oral
Duration:15 days
Control Inter
Sponsors
GuruNanda LLC
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion in this study only if all of the following criteria are fulfilled: 1. Able to provide written informed consent. 2. Able and willing to comply with the protocol, including availability for all scheduled study visits. 3.Adults, mix of male & female, age group 18 to 50 (both inclusive) years requiring oral hygiene treatment of gums & teeth to control tooth germs. 4. With MGI score =1.75 and plaque index score =1.95 (Turesky modification of Quigley-Hein Index)
Exclusion criteria
Exclusion criteria: Patients will not be eligible for inclusion in this study if meets any one of the following criteria: 1. A known history or present condition of hypersensitivity to any oral hygiene product. 2. Use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month of the screening visit. 3. History of periodontal therapy by surgical interventions. 4. History of dentine hypersensitivity treatment or presence of moderate to severe dentine hypersensitivity. 5. Orthodontic treatment with fixed appliances. 6. Presence of any removable device such as a removable partial denture or orthodontic retainer. 7. Presence of any fixed appliance, large or defective restorations or cracked enamel. 8. History or currently using tobacco products. 9. Presence of abnormal frenum attachment. 10. Presence of severe level of calculus and tartar. 11. Any other medical condition or serious intercurrent illness that, in the opinion of the principal investigator (PI), may make it undesirable for the patient to participate in the study that would limit adherence to study requirements. 12. Participation in another clinical study or receipt of any IP or oral care product during the previous 1 month of the screening visit. 13. Lactating / pregnant female patients. 14. Patients with signs and symptoms of coronavirus disease 2019 (COVID-19) during screening and baseline. 15. No other ongoing medications/supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of test product in comparison with active comparator product & placebo on oral microflora, dental plaque & gingivitis.Timepoint: 15 day | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify the impact of test product on oral malodour & oral dryness, in comparison with active comparator product and placebo. • To evaluate the efficacy of test product in enhancing teeth brightness (esthetics), in comparison with active comparator product and placebo. • To evaluate safety & tolerability of test product in comparison with active comparator product and placebo.Timepoint: 15 days | — |
Countries
India
Contacts
Public ContactMr Nimish Dudhatra
Concept Clinical Services
Outcome results
None listed