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

ConditionsDentin Hypersensitivity Erosive Tooth Wear

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIndiana University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will be idenified from five regions in the United states who meet the inclusion/exclusion criteria listed in this application

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

2,500 Participants

are divided into 1 treatment group

Group A: Adults age 18 living in five different areas of the United States1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

Ten minutes assessment period.

Secondary outcomes

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.

Time frame

Five minute examination period

Other outcomes

Compare study data to previously collected data

ETW and DH prevalence and risk factors observed in this study (U.S. data) will be compared to those collected in previous studies similarly designed and conducted in Europe and China.

Time frame

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

HALEON

Collaborator

Source ClinicalTrials.gov

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