Dentine HypersensitivityNCT07741032
A Study to Evaluate the Dentinal Hypersensitivity Efficacy of Two Experimental Mouthwash Formulations
A study testing 3% KNO3 Mouthwash, 2% HPC Mouthwash and 0% KNO3 Mouthwash in people with Dentine Hypersensitivity, run by HALEON at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- 3% KNO3 Mouthwash, 2% HPC Mouthwash and 0% KNO3 Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2012to 9 Jul 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant who demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participant understands and is willing, able and likely to comply with all study procedures and restrictions.
- A participant with a minimum of 20 natural teeth and in good general health who suffer from tooth sensitivity.
- At screening, participants with a minimum of four accessible nonadjacent teeth (incisors, canines, or pre-molars) with signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- At screening, self-reported history of Dentinal Hypersensitivity lasting more than 6 months but not more than 10 years.
- At Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria: - Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple less than or equal to [<=] 20 gram) and evaporative (air) assessment (Schiff Sensitivity Score greater than or equal to [>=] 2)
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breastfeeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the Screening visit.
- Participation in a desensitising treatment study within 8 weeks of the Screening visit.
- Previous participation in this study.
Show all 14Show fewer
- Recent history (within the last year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Dental prophylaxis within 4 weeks of Screening.
- Tongue or lip piercing or presence of dental implants.
- Desensitizing treatment within 8 weeks of Screening.
- Teeth bleaching within 8 weeks of Screening.
- Any participant who, in the judgment of the investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Study to Evaluate the Efficacy of Two Experimental Mouthwash Formulations in the Relief of Dentinal Hypersensitivity
The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily for the treatment of dentinal hypersensitivity.
Read the detailed description
This study will be an 8 week, randomized, examiner blind four treatment arm, parallel group design, stratified (by Baseline Schiff Sensitivity Score), in participants that meet all the criteria at the Screening and Baseline visits. Approximately 280 participants will be screened to randomize approximately 115 participants (to achieve approximately 30 participants to complete in each treatment group for twice daily usage and 15 to complete for the once daily usage group).
- Conditions
- Dentine Hypersensitivity
- Being tested
- 3% KNO3 Mouthwash, 2% HPC Mouthwash, 0% KNO3 Mouthwash
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% KNO3 MouthwashOther
3.0% weight by weight (w/w) KNO3 with 217 parts per million (ppm) sodium fluoride.
2% HPC MouthwashOther
2.0% w/w HPC mouthwash with 217ppm sodium fluoride.
0% KNO3 MouthwashOther
0% w/w KNO3 with 217ppm sodium fluoride.
| Study group | Role | What they receive |
|---|---|---|
| 3% KNO3 Mouthwash Twice Daily | Experimental | After brushing the teeth for 1 timed minute followed by rinsing with 10 milliliter (ml) potable water for 5 seconds, participants will be instructed to swish with 10ml of 3 percent (%) potassium nitrate (KNO3) Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks. Receives: Other: 3% KNO3 Mouthwash |
| 3% KNO3 Mouthwash Once Daily | Experimental | After brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 3% KNO3 Mouthwash for 1 timed minute once daily (morning only) for 8 Weeks. Receives: Other: 3% KNO3 Mouthwash |
| 2% HPC Mouthwash Twice Daily | Experimental | After brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 2% hydroxypropyl cellulose (HPC) Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks. Receives: Other: 2% HPC Mouthwash |
| 0% KNO3 Mouthwash Twice Daily | Placebo comparator | After brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 0% KNO3 Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks. Receives: Other: 0% KNO3 Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8
Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
Measured: Baseline, Weeks 4, 6 and 8
Change From Baseline in Tactile Threshold at Weeks 4, 6 and 8
Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram. An increase in tactile threshold (gram) indicates improvement. Change from Baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.
Measured: Baseline, Weeks 4, 6 and 8
Secondary outcomes (4)
Change From Baseline in Individual Questions Score from Dentine Hypersensitivity Experience Questionnaire (DHEQ) at Weeks 4 and 8
The DHEQ is used to measure how Dentin Hypersensitivity (DH) affects participants quality of life. Participant will respond to three individual questions from section 1 of DHEQ- 1. How intense are the sensations? 2. How bothered are you by any sensations? 3. How well can you tolerate sensations? The response to the questions will be scored using a 10-point scale ranging from 1 to 10, where lower score indicates a less severity of symptoms. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
Measured: Baseline, Weeks 4 and 8
Change From Baseline in DHEQ Total Score at Week 4 and 8
The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants will score each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Measured: Baseline, Weeks 4 and 8
Change From Baseline in Global Oral Health Score at Week 4 and 8
Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Measured: Baseline, Weeks 4 and 8
Change From Baseline in Effect on Life Overall Score at Week 4 and 8
Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Measured: Baseline, Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start26 Mar 2012
- Primary completion9 Jul 2012
- Study completion9 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine HypersensitivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741032
- Sponsor's protocol ID
- RH01474
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Efficacy of Two Experimental Mouthwash Formulations in the Relief of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT07741032
- Acronym / sponsor ID
- RH01474
- Conditions
- Dentine Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 9 Jul 2012 (actual)
- Study completion
- 9 Jul 2012 (actual)
- First posted
- 3 Aug 2026 (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.
The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily for the treatment of dentinal hypersensitivity.
Detailed description
This study will be an 8 week, randomized, examiner blind four treatment arm, parallel group design, stratified (by Baseline Schiff Sensitivity Score), in participants that meet all the criteria at the Screening and Baseline visits. Approximately 280 participants will be screened to randomize approximately 115 participants (to achieve approximately 30 participants to complete in each treatment group for twice daily usage and 15 to complete for the once daily usage group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3% KNO3 Mouthwash Twice Daily | Experimental | Other: 3% KNO3 MouthwashAfter brushing the teeth for 1 timed minute followed by rinsing with 10 milliliter (ml) potable water for 5 seconds, participants will be instructed to swish with 10ml of 3 percent (%) potassium nitrate (KNO3) Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks. |
| 3% KNO3 Mouthwash Once Daily | Experimental | Other: 3% KNO3 MouthwashAfter brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 3% KNO3 Mouthwash for 1 timed minute once daily (morning only) for 8 Weeks. |
| 2% HPC Mouthwash Twice Daily | Experimental | Other: 2% HPC MouthwashAfter brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 2% hydroxypropyl cellulose (HPC) Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks. |
| 0% KNO3 Mouthwash Twice Daily | Placebo comparator | Other: 0% KNO3 MouthwashAfter brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 0% KNO3 Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant who demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participant understands and is willing, able and likely to comply with all study procedures and restrictions.
- A participant with a minimum of 20 natural teeth and in good general health who suffer from tooth sensitivity.
- At screening, participants with a minimum of four accessible nonadjacent teeth (incisors, canines, or pre-molars) with signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- At screening, self-reported history of Dentinal Hypersensitivity lasting more than 6 months but not more than 10 years.
Key exclusion criteria (14 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breastfeeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the Screening visit.
- Participation in a desensitising treatment study within 8 weeks of the Screening visit.
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 |
|---|---|---|
| 3% KNO3 Mouthwash3.0% weight by weight (w/w) KNO3 with 217 parts per million (ppm) sodium fluoride. | Other | 3% KNO3 Mouthwash Once Daily, 3% KNO3 Mouthwash Twice Daily |
| 2% HPC Mouthwash2.0% w/w HPC mouthwash with 217ppm sodium fluoride. | Other | 2% HPC Mouthwash Twice Daily |
| 0% KNO3 Mouthwash0% w/w KNO3 with 217ppm sodium fluoride. | Other | 0% KNO3 Mouthwash Twice Daily |
Primary outcome
Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8
Time frame: Baseline, Weeks 4, 6 and 8
Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
Change From Baseline in Tactile Threshold at Weeks 4, 6 and 8
Time frame: Baseline, Weeks 4, 6 and 8
Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram. An increase in tactile threshold (gram) indicates improvement. Change from Baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.
4 secondary outcomes
Change From Baseline in Individual Questions Score from Dentine Hypersensitivity Experience Questionnaire (DHEQ) at Weeks 4 and 8
Time frame: Baseline, Weeks 4 and 8
Change From Baseline in DHEQ Total Score at Week 4 and 8
Time frame: Baseline, Weeks 4 and 8
Change From Baseline in Global Oral Health Score at Week 4 and 8
Time frame: Baseline, Weeks 4 and 8
Change From Baseline in Effect on Life Overall Score at Week 4 and 8
Time frame: Baseline, Weeks 4 and 8
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 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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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 3% KNO3 Mouthwash, 2% HPC Mouthwash and 0% KNO3 Mouthwash in people with Dentine Hypersensitivity, run by HALEON 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 6 inclusion and 14 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 Aug 2026. 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. Some participants in this study may receive a placebo. 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 From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8 (time frame: Baseline, Weeks 4, 6 and 8). The study lists 2 primary outcomes in all. 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 Aug 2026.