Improving dentures for patient benefit
ISRCTN | ISRCTN01528038 |
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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
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 |
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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 |
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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
LS2 9LU
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
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/ |
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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 | |
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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 | Date added | Peer reviewed? | Patient-facing? |
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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.