Back to resultsClinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mouthrinse (IQP-OLP-101)
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Praxisklinik ORS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Outcomes
Primary Outcome Measures
Change in dentine hypersensitivity
Assessed by subjects using VAS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03232255
Brief Title
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
Official Title
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mouthrinse (IQP-OLP-101)
Intervention Description
Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.
Primary Outcome Measure Information:
Title
Change in dentine hypersensitivity
Description
Assessed by subjects using VAS
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Praxisklinik ORS
City
Fellbach
ZIP/Postal Code
70736
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
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