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
Total final enrolment
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
24/06/2019
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
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
30/09/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32682922/ (added 05/08/2020)