- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02449434
Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.
Study Overview
Status
Conditions
Detailed Description
The study group will consist of two cohorts, those presenting with tooth wear and a control group. Participants will be recruited from the care planning clinic of the Dental Institute King's College London. Suitable participants meeting the inclusion criteria will be approached on the clinic, given the patient information sheet and asked to consider participating. Written consent will be obtained from those accepting the request. An interviewer-led, previously validated questionnaire will question their frequency and timing of dietary acid intake, tooth brushing and any habits associated with dietary acid intake. This will be followed by a Basic Erosive Wear Examination.
The process will take 7-8 minutes and the participant is free to withdraw at any time
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, SE1 9RT
- Dental Institute, Guy's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants
- Adult 18 years or older
- No missing anterior teeth
- minimum of at 10 teeth in the upper and 10 teeth in the lower jaw
- No anterior crowns/ bridges or implants
- Written consent to the study
Exclusion Criteria:
- Pregnancy
- Participation in other research within 30 days
- Unable to speak or understand English
- Presence of periodontal disease or caries on more than one tooth
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Severe Tooth Wear
Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants Adult 18 years or older No missing anterior teeth Minimum of at 10 teeth in the upper and 10 teeth in the lower jaw No anterior crowns/ bridges or implants Written consent to the study There was no intervention - just a questionnaire for each group |
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Without Tooth Wear
BEWE score of 10 or lower and no score of 3 on any surface of any tooth (clinically classified as no or mild erosive tooth wear) Adult 18 years or older No missing anterior teeth Minimum of at 10 teeth in the upper and 10 teeth in the lower jaw No anterior crowns/ bridges or implants Written consent to the study There was no intervention - just a questionnaire for each group |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Basic Erosive Wear Examination
Time Frame: Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes
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Each tooth will be graded by the extent of the surface which the acid has damaged.
The Basic Erosive Wear Examination (BEWE) index will grade tooth wear on the buccal, occlusal and palatal/lingual surfaces of each tooth excluding third molars.
This ordinal scale graded tooth wear from 0 to 3 (0 = no wear, 1 = early surface loss, 2 = surface loss < 50% or specific defect, 3 = surface loss > 50%).
The worst score in each sextant will be taken to be the sextant score.
A cumulative score will be calculated for the mouth by adding each sextant score, which can range from 0-18.
A higher score indicates a higher level of erosive tooth wear (worse outcome)
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Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Bartlett, BDS PhD, King's College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJ114/N205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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