Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.

NCT07195357 | Recruiting

• 1 other identifier: 28041
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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 to investigate their association with risk factors

Conditions

Erosive Tooth Wear; Dentin Hypersensitivity

Keywords

erosive tooth wear; ETW; Dentin hypersensitivity; DH; Tooth Sensitivity; Dental Erosion

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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: 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.

  Ten minutes assessment period.

Secondary Outcomes (1)

• Gum tissue recession presence, assessed on captured intraoral scans by a trained examiner.

  Five minute examination period

Other Outcomes (1)

• Compare study data to previously collected data

  0

Study Arms (1)

Adults age 18 living in five different areas of the United States

The five areas are Indiana, Florida, California, Texas and North Carolina

Other: epidemiological

Interventions

epidemiological OTHER

collection of data from all participating subjects involving tooth erosion examinations, tooth sensitivity and questionnaire data collection

Adults age 18 living in five different areas of the United States

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• Have a minimum of 10 teeth not including implants or teeth with crowns or bridges.
• 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

Sponsors & Collaborators

• Indiana University: lead
• HALEON: collaborator

Study Sites (1)

Indiana University School of Dentistry - Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity; Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Wear

Central Study Contacts

Anderson Hara, MS, PhD

CONTACT

317 274 8822; ahara@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MS

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)