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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02449434
Other study ID # RJ114/N205
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date June 2016

Study information

Verified date February 2016
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date June 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Dental Institute, Guy's Hospital London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

O'Toole S, Bernabé 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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) Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes
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