Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving dentures for patient benefit: a single centre randomised, controlled, crossover clinical trial comparing materials for complete dentures
Acronym
IMPROVDENT
Study hypothesis
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
Not provided at time of registration
Study design
Single-centre randomised controlled cross-over clinical trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please use the contact details below to request a patient information sheet.
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/01/2010
Overall trial end date
15/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
85
Participant 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
Recruitment start date
15/01/2010
Recruitment end date
15/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Faculty of Medicine and Health
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16300)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22937901
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24995473
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24995472
Publication citations
-
Protocol
Gray JC, Navarro-Coy N, Pavitt SH, Hulme C, Godfrey M, Craddock HL, Brunton PA, Brown S, Dillon S, Dukanovic G, Fernandez C, Wright J, Collier H, Swithenbank S, Lee C, Hyde TP, IMPROVDENT: improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures., BMC Oral Health, 2012, 12, 37, doi: 10.1186/1472-6831-12-37.
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Results
Hyde TP, Craddock HL, Gray JC, Pavitt SH, Hulme C, Godfrey M, Fernandez C, Navarro-Coy N, Dillon S, Wright J, Brown S, Dukanovic G, Brunton PA, A randomised controlled trial of complete denture impression materials., J Dent, 2014, 42, 8, 895-901, doi: 10.1016/j.jdent.2014.02.005.
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Results
Hulme C, Yu G, Browne C, O'Dwyer J, Craddock H, Brown S, Gray J, Pavitt S, Fernandez C, Godfrey M, Dukanovic G, Brunton P, Hyde TP, Cost-effectiveness of silicone and alginate impressions for complete dentures, J Dent, 2014 , 42, 8, 902-907, doi: 10.1016/j.jdent.2014.03.001.