Improving dentures for patient benefit

Improving dentures for patient benefit: a single centre randomised, controlled, crossover clinical trial comparing materials for complete dentures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01528038

Enrollment

Registered

2010-01-04

Start date

2010-01-15

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of denture production Not Applicable Fitting and adjustment of other devices

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026