Improving dentures for patient benefit

ISRCTN	ISRCTN01528038
DOI	https://doi.org/10.1186/ISRCTN01528038
Secondary identifying numbers	N/A

Submission date: 11/11/2009
Registration date: 04/01/2010
Last edited: 24/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr T Paul Hyde
Scientific

Leeds Dental Institute
Clarendon Road
Leeds University
Leeds
LS2 9LU
United Kingdom

Study information

Study design	Single-centre randomised controlled cross-over clinical trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format. Please use the contact details below to request a patient information sheet.
Scientific title	Improving dentures for patient benefit: a single centre randomised, controlled, crossover clinical trial comparing materials for complete dentures
Study acronym	IMPROVDENT
Study objectives	The aim of this study is to significantly impact on the quality of denture production within NHS dentistry. To achieve this objective, we aim to provide evidence of effectiveness and cost-effectiveness of a development in denture impression materials. The aim is to ask the patients to provide the outcome assessments for the trial; a user-centered approach which will give clinically significant results, empower research participants and facilitate a deeper understanding of patients' denture wearing problems.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Quality of denture production
Intervention	Patients should be assessed for their suitability to participate in this study before they give their consent and are registered into the trial. Denture construction: The Prosthodontic Research Team at the Leeds Dental Institute has developed and published a method of producing two or more sets of dentures which are clinically identical apart from the one deliberate alteration which is to be the subject of this trial. This methodology will be used to produce two sets of dentures which are clinically identical apart from the impression material that was used to provide the mould for the fitting surface of each denture. Habituation: Patients will be given both sets of dentures for a 2-week habituation period. During the 2 weeks the patients will be provided with a diary and asked to record the wearing of each set of dentures. They will then be asked to score each denture for comfort, mobility and chewing efficiency using a 5-point Likert scale. Both sets of dentures will be returned and re-marked for the adjustment stage. The code will be blind to clinicians and patients, and kept confidential until the end of the trial. Adjustment: Dentures will be given back to patients, one at a time over two adjustment periods (8 weeks each), in random order. If any adjustment or remedial work is required to make the dentures comfortable, retentive and useful this will be carried out by an experienced clinician. Within the limits of the LDI appointment system there will be no restriction on the number of appointments the patients can request during these two 8-week periods. Every appointment requested by the patient will be noted and a detailed record of the work required will be kept. At the end of each 8-week adjustment period the patient will be asked to attend and report the impact the dentures have had on their quality of life by the completion of a OHIP-EDENT and EQ-5D questionnaires and will rate the denture for comfort, mobility and chewing efficiency using 5-point Likert Scales. Confirmation: After the two adjustment periods of 8 weeks it is to be expected that each set of dentures will be as good as it is possible to make them. The patient will be asked to take both sets of dentures away for a 2-week confirmation period and return for a final visit to express any preference for the dentures and perform a Likert assessment of comfort, mobility, and chewing efficiency.
Intervention type	Other
Primary outcome measure	Patient preference for unadjusted dentures and overall cost-effectiveness, measured at the end of the habituation period. Patient preference will be established by asking whether one or other denture is preferred, or whether there is no preference. Those expressing no preference will be further asked whether both dentures were satisfactory or unsatisfactory.
Secondary outcome measures	Measured at the end of the secondary impressions, habituation, adjustment and confirmation periods: 1. Comfort, Mobility, Chewing Efficiency using 5-point Likert Scales 2. Oral Health-Related Quality of Life using OHIP-EDENT 3. Patient preference for adjusted dentures 4. Patient perception of comfort, taste and ease of use of each impression material using a 5-point Likert scale 5. Qualitative interviews to gain insight into the impact of oral health status on daily lives Patient preference for adjusted dentures will be established by asking whether one or other denture is preferred, or whether there is no preference. Those expressing no preference will be further asked whether both dentures were satisfactory or unsatisfactory. Patients will be asked to reflect on the whole process of receiving the final denture (including initial comfort, amount of adjustment needed) when expressing preference.
Overall study start date	15/01/2010
Completion date	15/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	85
Key inclusion criteria	1. Patients of either sex who are edentulous 2. Subject is available for follow up 3. Subject requires replacement complete dentures 4. Subject is able and willing to sign the Informed Consent Form 5. Aged 18 years or over at the time of signing the Informed Consent Form
Key exclusion criteria	1. Presence of an oral tumour 2. Requirement for an obturator 3. Extreme xerostomia (e.g. Sjogren's Syndrome) 4. Patients who would benefit from selective pressure impressions 5. Known hypersensitivity to silicone or alginate
Date of first enrolment	15/01/2010
Date of final enrolment	15/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leeds Dental Institute

Leeds
LS2 9LU
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Faculty of Medicine and Health
Level 10, Worsley Building
Clarendon Way
Leeds
LS2 9JT
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16300)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	31/08/2012	Yes	No
Results article	results	01/08/2014	Yes	No
Results article	results	01/08/2014	Yes	No

Editorial Notes

24/08/2016: Publication reference added.