NCT07195357 · Indiana University
Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
epidemiological
collection of data from all participating subjects involving tooth erosion examinations, tooth sensitivity and questionnaire data collection
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Have a minimum of 10 teeth not including implants or teeth with crowns or bridges. Exclusion Criteria:
- 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
Where
- Indianapolis, Indiana
Collaborators
HALEON
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations