Dentine HypersensitivityNCT07768969
Study to Investigate the Effect of Changes in Dentinal Hypersensitivity on Oral Health Parameters
A study testing Test Toothpaste in people with Dentine Hypersensitivity, run by HALEON at 1 site in United Kingdom.
Trial summary
This exploratory study will investigate the effect of long-term management of Dentine Hypersensitivity (DH) by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene (as measured by supra-gingival plaque accumulation), with associated changes in gingival health. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Test Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2013to 4 Mar 2014
- 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
- 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.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator,
- No clinically significant or relevant abnormalities of medical history or oral examination which could impact study outcomes.
- The absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- At screening, self-reported history of DH lasting more than 6 months but not more than 10 years.
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- At screening, minimum of two accessible teeth (incisors, canines or pre-molars) that meet all of the following criteria:
- Tooth with signs of erosion, abrasion and/or facial/cervical gingival recession (EAR).
- Tooth with signs of sensitivity measured by qualifying evaporative (air) assessment.
- At Baseline, minimum of two accessible teeth (incisors, canines or pre-molars), that meet 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 breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study/Experimental Medication
- Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit.
- Participation in a tooth desensitizing treatment study within 8 weeks of the screening visit.
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- Previous participation in this study.
- 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.
- Disease
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, is causing xerostomia.
- General Dentition Exclusions
- Dental prophylaxis within 4 weeks of screening.
- Tongue or lip piercing
- Desensitizing treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments).
- Treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planing within 3 months of screening.
- Teeth bleaching within 8 weeks of screening.
- Current active caries or periodontitis which, in the opinion of the investigator, could affect study outcomes, or the health of the subject if they participate in the study.
- Partial dentures, orthodontic appliances or dental implants which, in the opinion of the investigator, could affect study outcomes.
- Restorations in a poor state of repair which, in the opinion of the investigator, could affect study outcomes.
- Specific Dentition Exclusions for Teeth Selected for Sensitivity Assessments
- Tooth with evidence of current or recent caries or reported treatment of decay in 12 months of screening.
- Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
- Sensitive tooth not expected, in the opinion of the investigator, to respond to treatment with an over-the-counter toothpaste.
- Use of a sensitivity oral care product within 8 weeks of screening.
- Any participants who, in the opinion of the investigator, should not participate in the study, use of medication which could interfere in the outcome of the study or require antibiotic prophylaxis for dental procedures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Intertek CRS Ltd
Ellesmere Port, Cheshire, CH65 4BW
About this study
This exploratory study will investigate the effect of long-term management of Dentine Hypersensitivity (DH) by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene (as measured by supra-gingival plaque accumulation), with associated changes in gingival health.
Read the detailed description
This is a single center, non-comparative design study to investigate the effect of long-term management of DH by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene, with associated changes in gingival health. Sufficient participants will be screened to ensure approximately 70 eligible participants get allocated the study toothpaste in order to ensure that approximately 60 participants complete the study.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Test Toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ToothpasteOther
Marketed toothpaste containing 5 percent (%) weight by weight (w/w) NovaMin / 1426 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Participants will brush with the test toothpaste using a manual toothbrush for 1 timed minute twice daily (morning and evening) for 24 weeks. Receives: Other: Test Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score
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 and up to Week 24
Change From Baseline in Tactile Threshold
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 and up to Week 24
Change From Baseline in Labelled Magnitude Scales (LMS) Score
The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 millimeter (mm) LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
Measured: Baseline and up to Week 24
Secondary outcomes (3)
Change From Baseline in Turesky Plaque Index (TPI)
TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. Disclosed plaque will be scored on a scale ranging from 0-6, where 0= No plaque, 1= Slight flecks of plaque at the cervical margin of the tooth, 2= Thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3= Band of plaque wider than 1 mm but covering less than (<)1/3 of the area, 4= Plaque covering at least 1/3 but less than 2/3 of the area, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicates improvement in the symptoms. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Measured: Baseline and up to Week 24
Change From Baseline in Modified Gingival Index [MGI]
The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis. It will be assessed on the facial and lingual surfaces of each scorable tooth using a 5-point scale ranging from 0 to 4, where 0= absence of inflammation 1= mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit. 2= mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit. 3= moderate inflammation; glazing, redness, oedema, and/or hypertrophy of the marginal or papillary gingival unit. 4= severe inflammation; marked redness, oedema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicates improvement in the symptoms. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Measured: Baseline and up to Week 24
Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score
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 and up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start27 Aug 2013
- Primary completion4 Mar 2014
- Study completion4 Mar 2014
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.
- More trials run by HALEONThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768969
- Sponsor's protocol ID
- RH01897
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effect of Changes in Dentinal Hypersensitivity on Oral Health Parameters
- ClinicalTrials.gov ID
- NCT07768969
- Acronym / sponsor ID
- RH01897
- Conditions
- Dentine Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 4 Mar 2014 (actual)
- Study completion
- 4 Mar 2014 (actual)
- First posted
- 17 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.
This exploratory study will investigate the effect of long-term management of Dentine Hypersensitivity (DH) by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene (as measured by supra-gingival plaque accumulation), with associated changes in gingival health.
Detailed description
This is a single center, non-comparative design study to investigate the effect of long-term management of DH by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene, with associated changes in gingival health. Sufficient participants will be screened to ensure approximately 70 eligible participants get allocated the study toothpaste in order to ensure that approximately 60 participants complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Other: Test ToothpasteParticipants will brush with the test toothpaste using a manual toothbrush for 1 timed minute twice daily (morning and evening) for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator,
- At screening, self-reported history of DH lasting more than 6 months but not more than 10 years.
- At screening, minimum of two accessible teeth (incisors, canines or pre-molars) that meet all of the following criteria:
Key exclusion criteria (27 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study/Experimental Medication
- Recent history (within the last year) of alcohol or other substance abuse.
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 |
|---|---|---|
| Test ToothpasteMarketed toothpaste containing 5 percent (%) weight by weight (w/w) NovaMin / 1426 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) | Other | Test Toothpaste |
Primary outcome
Change From Baseline in Schiff Sensitivity Score
Time frame: Baseline and up to Week 24
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
Time frame: Baseline and up to Week 24
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.
Change From Baseline in Labelled Magnitude Scales (LMS) Score
Time frame: Baseline and up to Week 24
The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 millimeter (mm) LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
3 secondary outcomes
Change From Baseline in Turesky Plaque Index (TPI)
Time frame: Baseline and up to Week 24
Change From Baseline in Modified Gingival Index [MGI]
Time frame: Baseline and up to Week 24
Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score
Time frame: Baseline and up to Week 24
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 17 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 Test Toothpaste in people with Dentine Hypersensitivity, run by HALEON at 1 site in United Kingdom.
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 27 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 17 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 United Kingdom. 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 From Baseline in Schiff Sensitivity Score (time frame: Baseline and up to Week 24). The study lists 3 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 17 Aug 2026.