Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
Conditions
Interventions
Intervention1: Toothpaste Containing Fluoro
Calcium Phosphosilicate
(Biomin): At the baseline, (Day 0) patients
with dentine hypersensitivity will
continue treatment with
fluoro-calcium phosphosilicat
Sponsors
Dr Amit Mishra
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex in the age group of 18 to 70 years. 2. Patients with a self-reported history of dentinal hypersensitivity and prescribed toothpaste containing fluorocalcium phosphosilicate by the Investigator. 3. No clinically significant or relevant abnormalities in medical history or upon oral examination, or condition that would impact the participants safety, wellbeing, or the outcome of the study. 4. Good general oral health, with a minimum of 20 natural teeth. 5. Any 2 or more teeth with signs of sensitivity measured by a qualifying evaporative air assessment (Schiff sensitivity score greater than or equal to 2) 6.Patients willing to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals either with active dental caries, heavily restored, or cracked teeth, or with orthodontic or prosthetic appliances, or with localized or generalized gingivitis or pulpitis and heavy calculus or using any desensitizing toothpaste or mouthwash or any other desensitizing products up to two weeks before the start of the study. 2. Patients who have undergone vital teeth bleaching within two weeks, before the screening date. 3. Pregnant and nursing women. 4. Women with childbearing potential not practicing a reliable method of birth control. 5. Patients with a known history of hypersensitivity to ingredients of investigational product. 6. Suspected inability or unwillingness to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste at Week 6.Timepoint: Day 0 and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste from baseline to Weeks 4, 8, 16, and 24. 2. To monitor the oral health-related quality of life (QOL) as measured by the Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15) post-treatment with fluoro-calcium phosphosilicate toothpaste. 3. To analyze time to meaningful dentin pain relief on the VAS scale from baseline to Weeks 4, 8, 16, and 24 post-treatment with fluoro-calcium phosphosilicate toothpaste. 4. To monitor gingival health and supra-gingival plaque levels at baseline, and Weeks 12 and 24. Timepoint: Weeks 4, 8, 12, 16, and 24 | — |
Countries
India
Contacts
Public ContactDr Amit Mishra
Shataayu Dental Clinic
Outcome results
None listed