Plain English Summary
Background and study aims
Around 2.7 million adults in the UK had been reported to suffer from complete tooth loss in 2009. With the years of life expectancy increasing and a sizeable number of people who have no natural teeth, there is a demand to restore teeth (albeit with the use of a dental prosthesis) to provide an acceptable quality of life. The biting surfaces of denture teeth can have an impact on the function and comfort of these dentures. This aim of this study is to assess if denture teeth which has a shape based on natural teeth provide higher patient satisfaction compared to the current denture teeth shape being used.
Who can participate?
Generally healthy adults who have complete tooth loss and require new dentures.
What does the study involve?
Each participant has two sets of dentures made for them. One set are dentures with a classic denture teeth shape and the other set of dentures use an enhanced denture teeth shape. Each patient is asked to wear each set for a period of two months. After wearing each set of dentures, participants are asked to filled in two patient satisfaction questionnaires.
What are the possible benefits and risks of participating?
Participants benefit from receiving the treatment that they need (i.e. the need to have new dentures as their current ones are not functional). The patient would also receive an extra set of dentures to use. There are no notable risks involved with participating.
Where is the study run from?
The Royal London Dental Hospital (UK)
When is study starting and how long is it expected to run for?
June 2016 to September 2018
Who is funding the study?
Queen Mary University of London (UK)
Who is the main contact?
1. Dr Michael Myint (scientific)
ha08714@qmul.ac.uk
2. Dr Philip Taylor (scientific)
p.d.taylor@qmul.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Michael Myint
ORCID ID
Contact details
Royal London Dental Hospital
Turner Street
London
E1 1BB
United Kingdom
+44 (0)20 7882 8663
ha08714@qmul.ac.uk
Type
Scientific
Additional contact
Dr Philip Taylor
ORCID ID
Contact details
Royal London Dental Hospital
Turner Street
London
E1 1BB
United Kingdom
+44 (0)20 7882 8619
p.d.taylor@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.05 date 25/01/2017
Study information
Scientific title
Patients satisfaction and quality life assessment when wearing complete dentures with teeth of different anatomical designs: a randomised controlled crossover pilot study
Acronym
Study hypothesis
The aim of this study is to assess and compare patients’ satisfaction and quality of life when wearing dentures with teeth of more detailed tooth morphology with teeth copying natural tooth morphology, and whether the enhanced denture provide better comfort and chewing ability than the classic denture.
Ethics approval
London - Westminster Research Ethics Committee, 06/04/2017, REC ref: 17/LO/0518
Study design
Pilot randomised controlled cross over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Complete tooth loss (edentulism)
Intervention
The patients will be randomised into 2 groups via a computerised block envelope process. This was done by using the website www.sealedenvelope.com . The two groups are named Group A and Group B. Group A will wear the the classic shaped dentures first for 2 months and after will wear the enhanced shaped dentures for a further 2 months. Group B will wear the enhanced shaped dentures first for 2 months and after will wear the classic shaped dentures for a further 2 months.
The treatment provided from the study is the construction of 2 complete dentures. The fabrication of these dentures involves making the first set first: taking moulds of the patients mouths, ensuring the general outline of the denture shape is correct on a template, adding denture teeth to this template and converting this template to a definitive plastic denture. So far this is the fabrication to make the first set of dentures.
To construct the second set of dentures, a mould is taken of the first set of dentures to have a copy template for the second dentures. The teeth on the copy template is then changed and converted to a definitive plastic denture. This would produce our second set of dentures.
Patients are then provided with their first dentures as dictated by which group they have been randomised into. They will wear these dentures for two months, attending a review appointment one week into this period to ensure there are no clinical concerns. At the end of the two months, patients will be asked to fill in a patient questionnaire (Prof. Fenlon's validated questionnaire) and a quality of life questionnaire (OHIP-EDENT).
The first set of dentures is then taken away and patients are provided with the second set of dentures to wear for two months, attending a review appointment one week into this period to ensure there are no clinical concerns. At the end of the two months, patients will be asked to fill in a patient questionnaire (Prof. Fenlon's validated questionnaire) and a quality of life questionnaire (OHIP-EDENT). At this point the patient is entitled to keep both sets of dentures and the study would have ended for them.
The total duration of the study is one year and 5 months. The total time involved for each participant will be approximately 8 months.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Patient satisfaction is assessed using Professor Fenlon's patient satisfaction with dentures questionnaire at the start and end of each two-month treatment period.
Secondary outcome measures
1. Quality of life is measured using the OHIP-EDENT questionnaire at the start and end of each two-month treatment period
2. Self-assessed chewing ability is measured using a questionnaire at the start and end of each two-month treatment period
3. Self-assessed aesthetics of each set of dentures is rated by patients using a questionnaire at the end of each two-month treatment period
Overall trial start date
19/06/2016
Overall trial end date
30/09/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Informed consent
2. Age 18-100 years
3. Any gender
4. Any ethnicity
5. Successful denture wearers (i.e. previous denture wearing experience – 3+ years) who need new dentures
6. No mental health issues
7. No problems of Xerostomia (dry mouth).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Any inclusion criteria not met
2. Under 18 years
3. The shape and size of the jaw bones - Any Cawood and Atwood classification that is other than Class 2 or 3 or 4:
Class 2 = a bone shape that is well rounded and of good height but with the remnants of a socket due to tooth being recently removed
Class 3 = a bone shape that is well rounded and of good height.
Class 4 = a bone shape that is knife edged and of reasonable height.
4. Unable to consent
5. Pregnant patients.
6. Patients unable to attend easily due to locality or occupation limitations.
7. Large skeletal base discrepancies. This relates to the positioning of the upper and lower jaw to each other. A large skeletal discrepancy would include the lower jaw being too far forward in relation to the upper jaw. Also the contrary where the lower jaw is too far back in relation to the upper jaw. These are called Class 3 and Class 2 Skeletal base relationships respectively.
8. Severe fibrous replacement. This means that there is an area of the oral tissue upon which the denture may be seated on where it has excess fibrous/scar tissue.
9. Maxillo-facial defects. The subject may have undergone surgery or have existing defects to the jaws or face due to multiple reasons such as tumours, cysts, trauma to the face and developmental facial defects. These can change the anatomy of the area where the dentures rely on heavily and can influence the trial.
Recruitment start date
01/04/2017
Recruitment end date
31/12/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal London Dental Hospital
Turner Street
London
E1 1BB
United Kingdom
Funders
Funder type
University/education
Funder name
Queen Mary, University of London
Alternative name(s)
QMUL
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary