Dentin Sensitivity
Conditions
Brief summary
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.
Interventions
OTHERMouthrinse (IQP-OLP-101)
Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.
Sponsors
InQpharm Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. At least one hypersensitive tooth in everyday life after PAV 1 in-office visit 2. At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit 3. At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry 4. Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root 5. For subjects entering the study at stage PAR-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery 6. Age ≥ 18 years and ≤ 75 years 7. Willing and able to attend the on-study visits 8. Willing and able to understand and to follow the study procedures and instructions 9. Good oral hygiene throughout the study 10. Written informed consent before participation in the study 11. Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)
Exclusion criteria
1. Hypersensitivity only due to sweets 2. Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate 3. Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months 4. Chronic systemic anti-inflammatory and analgesic medications 5. Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.) 6. Teeth or supporting structures with any other painful pathology or defect 7. Subject with poor health conditions 8. Concurrent participation in another clinical trial 9. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dentine hypersensitivity | 28 days | Assessed by subjects using VAS |
Countries
Germany
Outcome results
None listed