Trial Outcomes & Findings for Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion. (NCT NCT02449434)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

600 participants

Primary outcome timeframe

Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes

Results posted on

2021-10-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Severe Erosive Tooth Wear a BEWE score of 12 or higher and at least one score of 3 in a sextant	Mild/Moderate Erosive Tooth Wear A BEWE score of 10 or lower and no score of 3 on any surface of any tooth
Overall Study STARTED	300	300
Overall Study COMPLETED	300	300
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Erosive Tooth Wear n=300 Participants BEWE score of 12 or higher and at least one score of 3 in a sextant whereas	Mild/Moderate Erosive Tooth Wear n=300 Participants BEWE score of 10 or lower and no score of 3 on any surface of any tooth	Total n=600 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	285 Participants n=5 Participants	285 Participants n=7 Participants	570 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	175 Participants n=7 Participants	313 Participants n=5 Participants
Sex: Female, Male Male	162 Participants n=5 Participants	125 Participants n=7 Participants	287 Participants n=5 Participants
Region of Enrollment United Kingdom	300 Participants n=5 Participants	300 Participants n=7 Participants	600 Participants n=5 Participants

PRIMARY outcome

Timeframe: Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes

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)

Outcome measures

Outcome measures
Measure	Severe Erosive Tooth Wear n=300 Participants Erosive tooth wear cases were defined as those with a BEWE score of 12 or higher and at least one score of 3 in a sextant	Mild/Moderate Erosive Tooth Wear n=300 Participants Controls were defined as those with a 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)
Basic Erosive Wear Examination	15.01 Units on a scale Standard Deviation 2.3	6.27 Units on a scale Standard Deviation 2.79

Adverse Events

Severe Erosive Tooth Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild/Moderate Erosive Tooth Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof David Bartlett

King's College London

Phone: 02071887462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place