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

September 14, 2021 updated by: King's College London
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Dental Institute, Guy's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Basic Erosive Wear Examination
Time Frame: 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)
Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Bartlett, BDS PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RJ114/N205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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