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

• Sponsor: King's College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02449434
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 24

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tooth Wear

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 Design

• Study Type: Observational
• Actual Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. Basic Erosive Wear Examination [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dental Institute, Guy's Hospital	London		United Kingdom	SE1 9RT

Sponsors and Collaborators

• King's College London

Investigators

• Principal Investigator: David Bartlett, BDS PhD, King's College London

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 3, 2013
• Informed Consent Form - Dec 1, 2013

More Information

Publications

None provided.

• Responsible Party: King's College London
• ClinicalTrials.gov Identifier: NCT02449434
• Other Study ID Numbers: RJ114/N205
• First Posted: May 20, 2015
• Last Update Posted: Oct 5, 2021
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Tooth Wear

Study Results

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.

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

Baseline Characteristics

Arm/Group Title	Severe Erosive Tooth Wear	Mild/Moderate Erosive Tooth Wear	Total
Arm/Group Description	BEWE score of 12 or higher and at least one score of 3 in a sextant whereas	BEWE score of 10 or lower and no score of 3 on any surface of any tooth	Total of all reporting groups
Overall Participants	300	300	600
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	285 95%	285 95%	570 95%
>=65 years	15 5%	15 5%	30 5%
Sex: Female, Male (Count of Participants)
Female	138 46%	175 58.3%	313 52.2%
Male	162 54%	125 41.7%	287 47.8%
Region of Enrollment (Count of Participants)
United Kingdom	300 100%	300 100%	600 100%

Outcome Measures

1. Primary Outcome

Title	Basic Erosive Wear Examination
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Severe Erosive Tooth Wear	Mild/Moderate Erosive Tooth Wear
Arm/Group Description	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	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)
Measure Participants	300	300
Mean (Standard Deviation) [Units on a scale]	15.01 (2.3)	6.27 (2.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Severe Erosive Tooth Wear, Mild/Moderate Erosive Tooth Wear
	Comments	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.
	Type of Statistical Test	Other
	Comments	Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Only results from fully adjusted regression models will be deemed as significant
	Method	Regression, Logistic
	Comments	Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.25
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Adverse Event Reporting Description	Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Arm/Group Title	Severe Erosive Tooth Wear		Mild/Moderate Erosive Tooth Wear
Arm/Group Description	BEWE score of 12 or higher and at least one score of 3 in a sextant Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed		BEWE score of 10 or lower and no score of 3 on any surface of any tooth Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
All Cause Mortality
	Severe Erosive Tooth Wear		Mild/Moderate Erosive Tooth Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Severe Erosive Tooth Wear		Mild/Moderate Erosive Tooth Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Severe Erosive Tooth Wear		Mild/Moderate Erosive Tooth Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.