NCT02449434

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

September 29, 2020

Completed
Last Updated

October 5, 2021

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

May 18, 2015

Results QC Date

January 9, 2020

Last Update Submit

September 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred into the Dental institute of King's College London for dental treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Institute, Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • O'Toole S, Bernabe E, Moazzez R, Bartlett D. Timing of dietary acid intake and erosive tooth wear: A case-control study. J Dent. 2017 Jan;56:99-104. doi: 10.1016/j.jdent.2016.11.005. Epub 2016 Nov 14.

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Prof David Bartlett
Organization
King's College London

Study Officials

  • David Bartlett, BDS PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 20, 2015

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

October 5, 2021

Results First Posted

September 29, 2020

Record last verified: 2016-02

Locations