Dentin SensitivityNCT03232255
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
A study testing Mouthrinse (IQP-OLP-101) in people with Dentin Sensitivity, run by InQpharm Group at 1 site in Germany.
Trial summary
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Mouthrinse (IQP-OLP-101)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2017to 7 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- Subject with poor health conditions
- Concurrent participation in another clinical trial
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.
- Conditions
- Dentin Sensitivity
- Being tested
- Mouthrinse (IQP-OLP-101)
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthrinse (IQP-OLP-101)Other
Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Other: Mouthrinse (IQP-OLP-101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dentine hypersensitivity
Assessed by subjects using VAS
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start25 Aug 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232255
- Sponsor's protocol ID
- 100080
- Status last verified
- Jan 2018
- First submitted
- 25 Jul 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
- ClinicalTrials.gov ID
- NCT03232255
- Acronym / sponsor ID
- 100080
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Mouthrinse (IQP-OLP-101) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouthrinse (IQP-OLP-101)Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day. | Other | Treatment Group |
Primary outcome
Change in dentine hypersensitivity
Time frame: 28 days
Assessed by subjects using VAS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthrinse (IQP-OLP-101) in people with Dentin Sensitivity, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dentine hypersensitivity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.