Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
Conditions
Interventions
Intervention1: Gurunanda oil pulling (coco-mint) oral rinse: 10 ml oral rinse once a day orally for 4 weeks
Control Intervention1: Placebo: 10 ml oral rinse once a day orally for 4 weeks
Sponsors
GURUNANDA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female subjects (age 18-65 yrs), 2.Subjects with atleast 20 permanent teeth excluding third molar. 3.Non-smokers with good oral and general health. 4.All 6 anterior maxillary teeth free of caries or restorations. 5.Tooth shade A2 or darker with no cervical lesions or prosthodontics treatments and with no periodontal disease. 6.Subjects should not use mouthwash 1 week prior to screening and during the whole course of the study. 7.All subjects should use the same toothpaste during the entire course of the study. 8.Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 9.Subjects should not have history of periodontal therapy one month prior to screening. 10.Patient should be able to give written informed consent prior to participating in the study.
Exclusion criteria
Exclusion criteria: 1.Individuals with discolored teeth (eg:- tetracycline and fluorosis). 2.Subjects having intrinsic stains. 3.Steroidal anti-inflammatory drugs, NSAIDs one month prior to screening. 4.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases). 5.Subjects with known sensitivity or oral mucosal tissue reaction to any components of the investigational product. 6.Pregnancy and breastfeeding women. 7.Participation in concomitant interventional clinical study during the previous 30 days. 8.Active oral infections, untreated cavities, or periodontal disease. 9.Presence of restorations on front teeth (e.g., crowns, veneers, or composite fillings) that could affect whitening results. 10.Recent dental procedures (e.g., scaling, polishing, or whitening) within the last 4 weeks. 11.Concurrent use of whitening products or treatments within the past 4 weeks. 12.Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco. 13.Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period. 14.Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine). 15.Presence of orthodontic appliances, except for removable retainers. 16.Signs of advanced enamel wear, dentin exposure, or tooth fractures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in teeth whiteningTimepoint: Screening,Day 0, week 2, week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Physical Examination 2.Oral examination. 3.Vital Signs: Pulse rate, blood pressure and body temperature 4.Lab assessment (Hematology, Biochemistry- SGOT, SGPT,and Serum Creatinine) (needed for safety evaluation 5. Adverse Event Assessments 6.Overall tolerability and satisfactionTimepoint: Screening, week 2, week 4. | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd
Outcome results
None listed