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Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.

Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02449434
Enrollment
600
Registered
2015-05-20
Start date
2014-05-31
Completion date
2016-06-30
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Wear

Brief summary

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

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

Interventions

None listed

Sponsors

King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants 2. Adult 18 years or older 3. No missing anterior teeth 4. minimum of at 10 teeth in the upper and 10 teeth in the lower jaw 5. No anterior crowns/ bridges or implants 6. Written consent to the study

Exclusion criteria

1. Pregnancy 2. Participation in other research within 30 days 3. Unable to speak or understand English 4. Presence of periodontal disease or caries on more than one tooth

Design outcomes

Primary

MeasureTime frameDescription
Basic Erosive Wear ExaminationSingle reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutesEach 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)

Countries

United Kingdom

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Severe Erosive Tooth Wear
BEWE score of 12 or higher and at least one score of 3 in a sextant whereas
300
Mild/Moderate Erosive Tooth Wear
BEWE score of 10 or lower and no score of 3 on any surface of any tooth
300
Total600

Baseline characteristics

CharacteristicSevere Erosive Tooth WearMild/Moderate Erosive Tooth WearTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
15 Participants15 Participants30 Participants
Age, Categorical
Between 18 and 65 years
285 Participants285 Participants570 Participants
Region of Enrollment
United Kingdom
300 Participants300 Participants600 Participants
Sex: Female, Male
Female
138 Participants175 Participants313 Participants
Sex: Female, Male
Male
162 Participants125 Participants287 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Severe Erosive Tooth WearBasic Erosive Wear Examination15.01 Units on a scaleStandard Deviation 2.3
Mild/Moderate Erosive Tooth WearBasic Erosive Wear Examination6.27 Units on a scaleStandard Deviation 2.79
Comparison: A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.p-value: <0.05Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026