Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
Conditions
Interventions
Intervention1: 2% Hydrogen Peroxide Teeth Whitening Strip: Dental whitening strips to be applied topically to the upper and lower teeth once daily for 2 weeks
Control Intervention1: Placebo: Dental wh
Sponsors
GURUNANDA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjects (age 18-50 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 A3 or darker with no cervical lesions or prosthodontics treatments and with no periodontal disease. 6. Subjects with no tooth sensitivity when assessed using a controlled air stimulus test, evaluated with the Schiff Sensitivity Scale 7. Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 8. Subjects should not have history of periodontal therapy one month prior to screening. 9. Patient should be able to give written informed consent prior to participating in the study.
Exclusion criteria
Exclusion criteria: 1.Individuals with discoloured 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 and anti-hypersensitive products or treatments within the past 3 months. 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. Subjects who do not practice daily oral hygiene. 16. Presence of orthodontic appliances, except for removable retainers. 17. Signs of advanced enamel wear, dentin exposure, or tooth fractures. 18. Presence of pre-existing tooth sensitivity or a medical or dental condition that may predispose the subject to tooth sensitivity. 19. Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement of tooth shade measured using VITA shade guide when compared to placebo. 2.Assessment of tooth sensitivity using a controlled air stimulus test, evaluated with the Schiff Sensitivity Scale.Timepoint: Screening, Randomised, week 1, week 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety will be assessed throughout by AE reporting, laboratory testing (hematology and biochemistry and UPT), physical examination, oral evaluation including adverse effects on oral soft tissues and dental restorations, and the occurrence of any irreversible oral side effects and vital signs. 2) Compliance and tolerability. 3) Overall treatment satisfaction questionnaire.Timepoint: Screening, week 2. | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd
Outcome results
None listed