Dentin HypersensitivityNCT07195357
Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.
An observational study of Dentin Hypersensitivity and Erosive Tooth Wear, run by Indiana University at 1 site in United States.
Trial summary
The goal of this observational study is to learn about tooth wear and tooth sensistivity and reasons for these conditions in five locations throughout the United States. The main question it aims to answer is: The main objective of this study is to determine tooth wear and tooth sensitivity in adults in the U.S., and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentin Hypersensitivity, Erosive Tooth Wear
- What is being tested?
- epidemiological
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to Oct 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
- Adult, Older adult
Study population: The study population will be idenified from five regions in the United states who meet the inclusion/exclusion criteria listed in this application
Who may be able to join
- Be aged 18 or over, of either gender.
- Be attending a regularly scheduled appointment at the dental school.
- Provide voluntary, written informed consent.
- Understand and be willing, able and likely to comply with all study procedures and restrictions.
- Be in good health (see exclusion criteria below).
- Have a minimum of 10 teeth not including implants or teeth with crowns or bridges.
Who cannot join
- Have any medical condition that could be expected to interfere with the subject's safety during the study period (including temporomandibular disorders).
- Be incapable of responding to the questions.
- Be an employee or a family relative of an employee of the sponsor.
- Be using maxillary or mandibular orthodontic appliances, except lingual bar.
- Have used analgesic (pain relieving) drugs or have used a topical analgesic in the preceding 12 h
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
Indiana University School of Dentistry - Oral Health Research Institute
Indianapolis, Indiana, 46202
Anderson T Hara, DDS, MSD, PhD, (317) 274-8822, ahara@iu.edu
Lorena galvez, crc, (317)274-8822, logalvez@iu.edu
About this study
Official title: Erosive Tooth Wear, Dentin Hypersensitivity and Associated Risk Factors: An Observational, Cross-Sectional, Multi-Site, Epidemiological Study in the U.S." IU IRB# 28041
The goal of this observational study is to learn about tooth wear and tooth sensistivity and reasons for these conditions in five locations throughout the United States. The main question it aims to answer is:
The main objective of this study is to determine tooth wear and tooth sensitivity in adults in the U.S., and to investigate their association with risk factors
Read the detailed description
The primary goal of this observational, cross-sectional, multi-site epidemiological study is to determine the prevalence of erosive tooth wear (ETW) and dentin hypersensitivity (DH) in healthy adults of different age brackets in the U.S., and to investigate their association with risk factors. A secondary goal is to assess gingival recession (GR) and presence of non-carious cervical lesion (NCCL). A tertiary goal is to compare the U.S. data with those from previous studies conducted in Europe and China.
Study participants will be healthy dentate adults aged 18 or older, recruited from clinics in dental schools (study sites), located in the U.S. Up to 5 study sites geographically distributed in the five U.S. regions (Midwest, Northeast, Southeast, Southwest, West) will participate in the study, with the goal of enrolling approximately 500 participants per site (total n = 2500), distributed nearly equally across age brackets (18-27, 28-37, 38-47, 48-57, 58+), and between males and females. In each site, a study team will be assigned with at least an investigator dental practitioner (dentist or dental hygienist) and a study coordinator will be assigned for the recruitment, consenting, examination, and intraoral scanning of participants. The main site under the direction of the PI will also include a project manager and an examiner for the digital images. Each site will file the study protocol, consent and associated documents through their own IRB using the respective documents approved by the Indiana University IRB. Each site may make modifications to the documents as required per each site's IRB.
Consented participants that agree to take part on the study and that meet the study inclusion and exclusion criteria will have clinical and self-reported data collected in a single study visit. Data sources will include questionnaire on demographics and associated factors, standardized intra-oral scanning of the full mouth and video recording of participants reactions while submitted to a DH test. The 3D digital images obtained from the intra-oral scans will be used for the digital assessment of ETW using the BEWE index. Video recordings will be used for the scoring of DH using the Schiff index and self-reported assessments. All digital scans and video recordings collected from the study sites will be managed by the lead site (Oral Health Research Institute - OHRI) and BEWE, GR and NCCL assessments will be performed digitally by previously trained examiner(s).
Preliminary, descriptive level analyses will be performed for the questionnaire variables. For each scoring variable, frequency distributions will be produced and summarized showing the variation between different areas of the mouth. The main analyses will be at the patient level, and the relationship between patient-level measures of each explanatory variable will be examined by crosstabulations and regression analyses.
- Conditions
- Dentin Hypersensitivity, Erosive Tooth Wear
- Being tested
- epidemiological
- Keywords
- erosive tooth wear, ETW, Dentin hypersensitivity, DH, Tooth Sensitivity, Dental Erosion
- Medical subject headings
- Dentin Sensitivity, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiologicalOther
collection of data from all participating subjects involving tooth erosion examinations, tooth sensitivity and questionnaire data collection
| Study group | Role | What they receive |
|---|---|---|
| Adults age 18 living in five different areas of the United States | The five areas are Indiana, Florida, California, Texas and North Carolina Receives: Other: epidemiological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and severity of erosive tooth wear (ETW), assessed using the basic erosive wear examination (BEWE) index.
ETW will be assessed on captured intraoral scans, for each tooth/subject using BEWE index. It will be performed by a previously trained and calibrated examiner. The BEWE scale presents 4 levels, from 0: no ETW to 3: most severe ETW.
Measured: Five minute examination period
Prevalence and severity of dentin hypersensitivity (DH) using the Schiff Sensitivity Index.
DH will be assessed on recorded video files by a previously trained examiner, who will watch the videos and provide a Schiff score for each tooth/subject. The Schiff scale has 5 severity levels, ranging from 0: no DH to 4: severe DH.
Measured: Five minute examination period
Risk factors potentially associated to erosive tooth wear (ETW) and dentin hypersensitivity (DH), collected by questionnaires.
Demographics and potential risk factors associated with ETW and DH will be collected from each subject by questionnaires. They will include:
- Demographic data; age, gender, socioeconomic status, education level achieved, location, race/ethnicity.
- Data on the participant's oral hygiene practices.
- Data about the participant's dentin hypersensitivity quality of life experience.
- Data on the participant's perception of their general oral health, toothwear and gum health.
- Data on the participant's perception of DH: intensity, duration, origin.
- Data on the evaluation of risk factors associated with ETW and DH.
Measured: Ten minutes assessment period.
Secondary outcomes (1)
Gum tissue recession presence, assessed on captured intraoral scans by a trained examiner.
A secondary outcome is presence (yes or no) of gum tissue recession (wearing away of the gum at the gumline), assessed by a trained examiner.
Measured: Five minute examination period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start19 Feb 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 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.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- HALEON
- Responsible party
- Principal investigator, Anderson T. Hara, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195357
- Sponsor's protocol ID
- 28041
- Status last verified
- Feb 2026
- First submitted
- 11 Sep 2025
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erosive Tooth Wear, Dentin Hypersensitivity and Associated Risk Factors: An Observational, Cross-Sectional, Multi-Site, Epidemiological Study in the U.S." IU IRB# 28041
- ClinicalTrials.gov ID
- NCT07195357
- Acronym / sponsor ID
- 28041
- Conditions
- Dentin Hypersensitivity, Erosive Tooth Wear
- Keywords
- erosive tooth wear, ETW, Dentin hypersensitivity, DH, Tooth Sensitivity, Dental Erosion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- HALEON
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Sep 2025 (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 goal of this observational study is to learn about tooth wear and tooth sensistivity and reasons for these conditions in five locations throughout the United States. The main question it aims to answer is:
The main objective of this study is to determine tooth wear and tooth sensitivity in adults in the U.S., and to investigate their association with risk factors
Detailed description
The primary goal of this observational, cross-sectional, multi-site epidemiological study is to determine the prevalence of erosive tooth wear (ETW) and dentin hypersensitivity (DH) in healthy adults of different age brackets in the U.S., and to investigate their association with risk factors. A secondary goal is to assess gingival recession (GR) and presence of non-carious cervical lesion (NCCL). A tertiary goal is to compare the U.S. data with those from previous studies conducted in Europe and China.
Study participants will be healthy dentate adults aged 18 or older, recruited from clinics in dental schools (study sites), located in the U.S. Up to 5 study sites geographically distributed in the five U.S. regions (Midwest, Northeast, Southeast, Southwest, West) will participate in the study, with the goal of enrolling approximately 500 participants per site (total n = 2500), distributed nearly equally across age brackets (18-27, 28-37, 38-47, 48-57, 58+), and between males and females. In each site, a study team will be assigned with at least an investigator dental practitioner (dentist or dental hygienist) and a study coordinator will be assigned for the recruitment, consenting, examination, and intraoral scanning of participants. The main site under the direction of the PI will also include a project manager and an examiner for the digital images. Each site will file the study protocol, consent and associated documents through their own IRB using the respective documents approved by the Indiana University IRB. Each site may make modifications to the documents as required per each site's IRB.
Consented participants that agree to take part on the study and that meet the study inclusion and exclusion criteria will have clinical and self-reported data collected in a single study visit. Data sources will include questionnaire on demographics and associated factors, standardized intra-oral scanning of the full mouth and video recording of participants reactions while submitted to a DH test. The 3D digital images obtained from the intra-oral scans will be used for the digital assessment of ETW using the BEWE index. Video recordings will be used for the scoring of DH using the Schiff index and self-reported assessments. All digital scans and video recordings collected from the study sites will be managed by the lead site (Oral Health Research Institute - OHRI) and BEWE, GR and NCCL assessments will be performed digitally by previously trained examiner(s).
Preliminary, descriptive level analyses will be performed for the questionnaire variables. For each scoring variable, frequency distributions will be produced and summarized showing the variation between different areas of the mouth. The main analyses will be at the patient level, and the relationship between patient-level measures of each explanatory variable will be examined by crosstabulations and regression analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults age 18 living in five different areas of the United States | – | Other: epidemiologicalThe five areas are Indiana, Florida, California, Texas and North Carolina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be idenified from five regions in the United states who meet the inclusion/exclusion criteria listed in this application
Key inclusion criteria (6 listed)
- Be aged 18 or over, of either gender.
- Be attending a regularly scheduled appointment at the dental school.
- Provide voluntary, written informed consent.
- Understand and be willing, able and likely to comply with all study procedures and restrictions.
- Be in good health (see exclusion criteria below).
Key exclusion criteria (5 listed)
- Have any medical condition that could be expected to interfere with the subject's safety during the study period (including temporomandibular disorders).
- Be incapable of responding to the questions.
- Be an employee or a family relative of an employee of the sponsor.
- Be using maxillary or mandibular orthodontic appliances, except lingual bar.
- Have used analgesic (pain relieving) drugs or have used a topical analgesic in the preceding 12 h
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 |
|---|---|---|
| epidemiologicalcollection of data from all participating subjects involving tooth erosion examinations, tooth sensitivity and questionnaire data collection | Other | Adults age 18 living in five different areas of the United States |
Primary outcome
Prevalence and severity of erosive tooth wear (ETW), assessed using the basic erosive wear examination (BEWE) index.
Time frame: Five minute examination period
ETW will be assessed on captured intraoral scans, for each tooth/subject using BEWE index. It will be performed by a previously trained and calibrated examiner. The BEWE scale presents 4 levels, from 0: no ETW to 3: most severe ETW.
Prevalence and severity of dentin hypersensitivity (DH) using the Schiff Sensitivity Index.
Time frame: Five minute examination period
DH will be assessed on recorded video files by a previously trained examiner, who will watch the videos and provide a Schiff score for each tooth/subject. The Schiff scale has 5 severity levels, ranging from 0: no DH to 4: severe DH.
Risk factors potentially associated to erosive tooth wear (ETW) and dentin hypersensitivity (DH), collected by questionnaires.
Time frame: Ten minutes assessment period.
Demographics and potential risk factors associated with ETW and DH will be collected from each subject by questionnaires. They will include: 1. Demographic data; age, gender, socioeconomic status, education level achieved, location, race/ethnicity. 2. Data on the participant's oral hygiene practices. 3. Data about the participant's dentin hypersensitivity quality of life experience. 4. Data on the participant's perception of their general oral health, toothwear and gum health. 5. Data on the participant's perception of DH: intensity, duration, origin. 6. Data on the evaluation of risk factors associated with ETW and DH.
1 secondary outcome
Gum tissue recession presence, assessed on captured intraoral scans by a trained examiner.
Time frame: Five minute examination period
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 5 May 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 and Erosive Tooth Wear, run by Indiana University 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 5 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 5 May 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 Anderson Hara, MS, PhD (317 274 8822, ahara@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and severity of erosive tooth wear (ETW), assessed using the basic erosive wear examination (BEWE) index. (time frame: Five minute examination period). 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 5 May 2026.