An observational study in Tooth Wear, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by King's College London · Observational
This is a questionnaire based study investigating the relationship between the timing of dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the timing, nature, frequency and duration of dietary acid intakes and timing and frequency of the participants toothbrushing. Signs of the participants erosive tooth wear will then be recorded
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
57 studies on the registry are indexed under Tooth Wear; 10 are open to participants now.
This study's enrollment of 600 is above the median of 71 across 20 observational studies indexed under Tooth Wear.
Browse Tooth Wear studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Patients referred into the Dental institute of King's College London for dental treatment
Exclusion 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 There was no intervention - just a questionnaire for each group
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
Basic Erosive Wear Examination
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)
Time frame: Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes
Participants (n = 600) aged 18 years or older, were recruited between May 2014 and March 2016 following referral by their general dental practitioners (GDP) for erosive tooth wear (cases, n = 300) or general treatment (controls, n = 300) to the restorative clinics at King's College London Dental Institute.
| Milestone | Severe Erosive Tooth Wear | Mild/Moderate Erosive Tooth Wear |
|---|---|---|
| Started | 300 | 300 |
| Completed | 300 | 300 |
| Not completed | 0 | 0 |
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)
| Units on a scale | Severe Erosive Tooth Wear | Mild/Moderate Erosive Tooth Wear |
|---|---|---|
| Basic Erosive Wear Examination | 15.01 ± 2.3 | 6.27 ± 2.79 |
Collected over Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Severe Erosive Tooth Wear | — | — | — |
| Mild/Moderate Erosive Tooth Wear | — | — | — |
| Age, Categorical(Participants) | Severe Erosive Tooth Wear | Mild/Moderate Erosive Tooth Wear | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 285 | 285 | 570 |
| >=65 years | 15 | 15 | 30 |
| Sex: Female, Male(Participants) | Severe Erosive Tooth Wear | Mild/Moderate Erosive Tooth Wear | Total |
|---|---|---|---|
| Female | 138 | 175 | 313 |
| Male | 162 | 125 | 287 |
| Region of Enrollment(Participants) | Severe Erosive Tooth Wear | Mild/Moderate Erosive Tooth Wear | Total |
|---|---|---|---|
| United Kingdom | 300 | 300 | 600 |
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King's College London