Dentin HypersensitivityNCT07337109
A Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers
An observational study of Dentin Hypersensitivity, run by HALEON at 1 site in United States.
Trial summary
The primary purpose of this study is to characterize changes in Oral-Health-Related Quality of Life (OHrQoL), as measured by the Dentin Hypersensitivity Experience Questionnaire (DHEQ) over a 12-month period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who are new sufferers of DH and have begun treating their DH.
Who may be able to join
- Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
- All genders who, at the time of screening, are aged more than or equal to (>=)18 years.
- Anyone who has begun to experience dentin hypersensitivity (self-reported) within the past three months.
- Anyone who has started to use products to treat their tooth sensitivity within the past three months.
- Participant who is able to independently complete all activities online.
- Participants residing in the United States.
Who cannot join
- Anyone who has any chronic health conditions that could impact their participation in this study, such as cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
- Anyone who suffers from tooth cavities, significant gum disease, cracked or fractured teeth, temporomandibular joint disease (TMD), or who has had tooth extractions or fillings within the last three months.
- Anyone who wears braces (including Invisalign-like appliances) for treatment or dentures (full or partial).
- Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
- Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
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- Participant who has been informed by a DHCP that they have active caries.
- Participant with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications (more than 3 days a week).
- Anyone who has participated in another dentin hypersensitivity study within the last three months.
- Currently participating in another research study or will be participating in any other research study at any point during this study's duration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Citruslabs (Virtual Site)
Las Vegas, Nevada, 89118
Ellen O'Gormon, Dr
About this study
Official title: A Longitudinal Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers in the Real World
The primary purpose of this study is to characterize changes in Oral-Health-Related Quality of Life (OHrQoL), as measured by the Dentin Hypersensitivity Experience Questionnaire (DHEQ) over a 12-month period.
Read the detailed description
This will be a longitudinal study investigating OHrQoL and treatment patterns amongst new sufferers of self-reported Dentin Hypersensitivity (DH). Over the 12-month study duration, 375 participants suffering from DH will complete questionnaires online once per month.
- Conditions
- Dentin Hypersensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New sufferers of self-reported Dentin Hypersensitivity aged 18+ years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total DHEQ Score Over 12 Months
Change from baseline in total DHEQ score and each of the domain scores (daily restrictions, coping behaviors, personal identity, social impact, emotional impact) over 12 months. The DHEQ has total 15 questions each will be scored on a scale ranging from 1 (strongly disagree) to 7 (strongly agree), thus total possible score will be ranging from 15 to 105, where higher score indicates worst outcome.
Measured: Baseline and up to 12 Months
Secondary outcomes (5)
Description of Treatment Selection Over 12 Months
Participants will select the appropriate options from the given list of products. Data will be summarized using descriptive statistics.
Measured: Up to 12 Months
Treatment Discontinuation/Switch Over 12 Months
Participant will respond to the question either as Yes or No. Data will be summarized using descriptive statistics.
Measured: Up to 12 Months
Frequency of Treatment Used Over 12 Months
Participants will select the appropriate frequency options from the given list. Data will be summarized using descriptive statistics.
Measured: Up to 12 Months
Frequency of DH Over 12 Months
Participants will select the appropriate frequency options from the given list. Data will be summarized using descriptive statistics.
Measured: Up to 12 Months
Frequency of Brushing at Baseline, Months 6 and 12
Participants will select the appropriate frequency options from the given list. Data will be summarized using descriptive statistics.
Measured: Baseline, Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start16 Dec 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337109
- Sponsor's protocol ID
- 400318
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers in the Real World
- ClinicalTrials.gov ID
- NCT07337109
- Acronym / sponsor ID
- 400318
- Conditions
- Dentin Hypersensitivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Jan 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 primary purpose of this study is to characterize changes in Oral-Health-Related Quality of Life (OHrQoL), as measured by the Dentin Hypersensitivity Experience Questionnaire (DHEQ) over a 12-month period.
Detailed description
This will be a longitudinal study investigating OHrQoL and treatment patterns amongst new sufferers of self-reported Dentin Hypersensitivity (DH). Over the 12-month study duration, 375 participants suffering from DH will complete questionnaires online once per month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New sufferers of self-reported Dentin Hypersensitivity aged 18+ years | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who are new sufferers of DH and have begun treating their DH.
Key inclusion criteria (6 listed)
- Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
- All genders who, at the time of screening, are aged more than or equal to (>=)18 years.
- Anyone who has begun to experience dentin hypersensitivity (self-reported) within the past three months.
- Anyone who has started to use products to treat their tooth sensitivity within the past three months.
- Participant who is able to independently complete all activities online.
Key exclusion criteria (10 listed)
- Anyone who has any chronic health conditions that could impact their participation in this study, such as cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
- Anyone who has participated in another dentin hypersensitivity study within the last three months.
- Currently participating in another research study or will be participating in any other research study at any point during this study's duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Total DHEQ Score Over 12 Months
Time frame: Baseline and up to 12 Months
Change from baseline in total DHEQ score and each of the domain scores (daily restrictions, coping behaviors, personal identity, social impact, emotional impact) over 12 months. The DHEQ has total 15 questions each will be scored on a scale ranging from 1 (strongly disagree) to 7 (strongly agree), thus total possible score will be ranging from 15 to 105, where higher score indicates worst outcome.
5 secondary outcomes
Description of Treatment Selection Over 12 Months
Time frame: Up to 12 Months
Treatment Discontinuation/Switch Over 12 Months
Time frame: Up to 12 Months
Frequency of Treatment Used Over 12 Months
Time frame: Up to 12 Months
Frequency of DH Over 12 Months
Time frame: Up to 12 Months
Frequency of Brushing at Baseline, Months 6 and 12
Time frame: Baseline, Months 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentin Hypersensitivity, run by HALEON at 1 site in United States.
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 10 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: looking for participants now, as of the sponsor's last update on 28 Apr 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haleon Response Center (+441932959500, ww.clinical-trial-register@haleon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total DHEQ Score Over 12 Months (time frame: Baseline and up to 12 Months). 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 28 Apr 2026.