Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT07195357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.
Sponsor:
Indiana University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: