Status:
COMPLETED
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
Lead Sponsor:
InQpharm Group
Conditions:
Dentin Sensitivity
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.
Eligibility Criteria
Inclusion
- At least one hypersensitive tooth in everyday life after PAV 1 in-office visit
- At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit
- At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry
- Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root
- 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
- Age ≥ 18 years and ≤ 75 years
- Willing and able to attend the on-study visits
- Willing and able to understand and to follow the study procedures and instructions
- Good oral hygiene throughout the study
- Written informed consent before participation in the study
- Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)
Exclusion
- Hypersensitivity only due to sweets
- Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate
- Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months
- Chronic systemic anti-inflammatory and analgesic medications
- Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.)
- Teeth or supporting structures with any other painful pathology or defect
- Subject with poor health conditions
- Concurrent participation in another clinical trial
- Pregnant or lactating women
Key Trial Info
Start Date :
August 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03232255
Start Date
August 25 2017
End Date
December 7 2017
Last Update
January 3 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Praxisklinik ORS
Fellbach, Germany, 70736