Tooth wear and sensitivity and their risk factors across U.S. dental school sites
Erosive Tooth Wear, Dentin Hypersensitivity and Associated Risk Factors: An Observational, Cross-Sectional, Multi-Site, Epidemiological Study in the U.S." IU IRB# 28041
This study will see how common tooth wear and tooth sensitivity are in U.S. adults and what factors are linked to them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07195357 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional, multi-site epidemiological study enrolling roughly 2,500 healthy dentate adults across up to five U.S. dental school clinics to measure the prevalence of erosive tooth wear and dentin hypersensitivity. Participants will undergo oral examinations, intraoral scanning, and standardized data collection on possible risk factors, with enrollment balanced across age brackets and sexes. Secondary measures include gingival recession and non-carious cervical lesions, and images will be reviewed centrally for consistency. The U.S. results will also be compared with prior datasets from Europe and China to identify similarities and regional differences.
Who should consider this trial
Good fit: Healthy adults aged 18 or older who have at least 10 natural teeth, attend a participating dental school appointment, and can provide informed consent are ideal candidates.
Not a fit: People with fewer than 10 natural teeth, active orthodontic appliances (except lingual bar), recent analgesic use, or medical conditions that affect safety or participation are unlikely to be eligible or benefit from this study.
Why it matters
Potential benefit: If successful, the results could help dentists recognize common risk patterns and target prevention and early care for tooth wear and sensitivity.
How similar studies have performed: Epidemiological studies in Europe and China have described patterns of erosive tooth wear and dentin hypersensitivity, but comparable multi-site U.S. data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be aged 18 or over, of either gender. 2. Be attending a regularly scheduled appointment at the dental school. 3. Provide voluntary, written informed consent. 4. Understand and be willing, able and likely to comply with all study procedures and restrictions. 5. Be in good health (see exclusion criteria below). 6. Have a minimum of 10 teeth not including implants or teeth with crowns or bridges. Exclusion Criteria: 1. Have any medical condition that could be expected to interfere with the subject's safety during the study period (including temporomandibular disorders). 2. Be incapable of responding to the questions. 3. Be an employee or a family relative of an employee of the sponsor. 4. Be using maxillary or mandibular orthodontic appliances, except lingual bar. 5. Have used analgesic (pain relieving) drugs or have used a topical analgesic in the preceding 12 h
Where this trial is running
Indianapolis, Indiana
- Indiana University School of Dentistry - Oral Health Research Institute — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Anderson Hara, MS, PhD
- Email: ahara@iu.edu
- Phone: 317 274 8822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.