Condition category
Not Applicable
Date applied
11/11/2009
Date assigned
04/01/2010
Last edited
24/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr T Paul Hyde

ORCID ID

Contact details

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

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 measures

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

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

http://www.leeds.ac.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes

24/08/2016: Publication reference added.