Condition category
Oral Health
Date applied
06/03/2019
Date assigned
18/03/2019
Last edited
11/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This research study has been designed to validate a new clinical scoring system (index) for dentists, which is focused at the junction where the gums meet the teeth. The index has been designed to look specifically for worn surfaces of the teeth and receding gums in this area as this is an increasing problem in the population and can often cause problems, such as sensitive teeth. The researchers are developing the index to act as a guide for dentists on how to manage problems in this area, such as receding gums from toothbrushing too vigorously and sensitivity from exposed dentine near the gum. It is hoped that once this index has been developed, the information can be given to dentists equipping them with better knowledge to advise and treat their patients.

Who can participate?
Healthy adults (over 18), with a minimum of 10 teeth

What does the study involve?
Participants attend one appointment which lasts about 30 minutes. The study visit consists of a short oral examination, which is repeated by three different research dentists to ensure they are scoring the same as each other. Each tooth is given two scores (one for the outside surface of the tooth near the cheek and one for the inside surface near the tongue/roof of the mouth) for any areas that show tooth wear and gum recession.

What are the possible benefits and risks of participating?
There are no direct, immediate benefits from taking part in the study. There are no risks of participating as all procedures and assessments are carried out by experienced and qualified dentists using standard dental instruments.

Where is the study run from?
Bristol Dental Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2018 to July 2019

Who is funding the study?
University of Bristol (UK)

Who is the main contact?
Dr Barbara Warnes
barbara.warnes@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barbara Warnes

ORCID ID

Contact details

Bristol Dental School
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
+44 (0)1173426937
barbara.warnes@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 225373

Study information

Scientific title

Cervical Localisation Code - Validation of a new code

Acronym

Cervical

Study hypothesis

The four cervical localisation codes proposed (0-3) represent clinically distinguishable scenarios which can be scored reproducibly.

Ethics approval

Approved 18/09/2018 by London - Queen Square Research Ethics Committee, HRA NRES Centre Manchester, Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, Tel: +44 (0)207 104 8225, 0207 104 8019, Email: nrescommittee.london-queensquare@nhs.net, REC ref: 18/LO/1418

Study design

Single-site cross-sectional observational epidemiological validation study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Healthy dentate adult volunteers aged 18 or over

Intervention

This is an observational study. The clinical examination will involve capturing scores for the cervical localisation code on all eligible tooth surfaces, 7-7 both arches (buccal and palatal/lingual). Certain dental exclusions will apply: missing teeth, teeth with gross caries, any tooth surface with crown or bridgework, any tooth surface with a fixed orthodontic appliance and any tooth surface with a large restoration in the proximity of the cementoenamel junction.

Participants will be randomised by study staff equally to 3 treatment sequence groups using a block randomisation scheme. The 3 investigator dentists are to be labelled A, B and C. Thirteen of the 39 participants will be scored by the 3 dentists in the sequence A-B-C-A, another 3 will be scored by the 3 dentists in the sequence B-C-A-B. The remaining 13 will be scored by the 3 dentists in the sequence C-A-B-C.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Inter- and Intra-examiner agreement of the proposed clinical classification (as assessed by the cervical localisation score) of the cervical region using three independent dentists assessing the same participants, in a randomised treatment sequence, at a single timepoint

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

13/06/2018

Overall trial end date

14/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy participants of either gender
2. Aged 18 or over
3. Understand and are willing, able and likely to comply with all study procedures and restrictions
4. Accept the form of the study and signs a declaration of informed consent
5. Have a minimum of 10 teeth not including implants or teeth with crowns and bridges

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

39

Participant exclusion criteria

1. An employee and/or family relative of the investigator dentist
2. Anyone who the investigator's opinion is not suitable to take part in the study

Recruitment start date

06/03/2019

Recruitment end date

17/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Dental School
University of Bristol Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
One Cathedral Square
Bristol
BS1 5DD
United Kingdom
+44 (0)1173429638
anna.brooke@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bristol.ac.uk/red/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

At the end of the study, the collected data will be analysed to establish the index reliability. The researchers will publish the trial results in appropriate peer-reviewed journals.

IPD sharing statement
The data will be stored in the University of Bristol Data Repository. The weblink to the repository is: data.bris.ac.uk/data but the researchers do not have a unique link to the data for this study yet. The data will be stored in an 'open' format so anyone can access it. Data will be available after the results have been published in a scientific journal (July 2020, 12 months from the last data collection point). The consent form contains the following statement: 'I understand that the information collected about me will be used to support other research in the future and may be shared anonymously with other researchers'. The clinical trials unit will allocate each participant a unique study ID number. On the CRF only date of birth, gender and participant ID are recorded. The only data stored electronically will identify the scoring numbers by study ID.

Intention to publish date

07/07/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes