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Optimizing clinical workflows for 3-D printed dentures

A preliminary study, evaluating and optimizing the clinical workflows to enable a pilot RCT of 3-D printed dentures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84598751
Enrollment
20
Registered
2020-04-09
Start date
2019-03-11
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

Dentures produced by 3D printing Oral Health

Interventions

A prospective cohort study of 20 patient participants is proposed. In order to gain the maximum input from experienced clinicians, this preliminary study is taking place in 3 centers of excellence wi
moving on directly to primary impressions at Study Clinical Visit 1. The primary impressions will follow the normal clinical routine. The participants will be randomised using computer-generated bloc

Sponsors

University of Leeds
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Edentulous 2. Available for follow-up 3. Requires replacement complete dentures 4. Able and willing to complete the informed consent process. 5. Aged 18 years or over at the time of signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: 1. Oral tumour 2. Denture stomatitis 3. Requires an obturator 4. Extreme xerostomia (e.g. Sjögren's syndrome) 5. Known hypersensitivity to dental materials used in the research 6. Incapable of written informed consent

Design outcomes

Primary

MeasureTime frame
Participant's preference of denture assessed at Study Clinical Visit 5 and analysed using McNemar's test

Secondary

MeasureTime frame
1. Clinician's assessment of the retention of the 3-D printed denture bases at jaw registration (Study Clinical Visit 3) and denture fit (Study Clinical Visit 5) using a 5-point Likert scale 2. Clinician's assessment of the stability of the 3-D printed denture bases at jaw registration (Study Clinical Visit 3) and denture fit (Study Clinical Visit 5) using a 5-point Likert scale 3. Clinicians preference for the base plate of the jaw registration blocks with options for 'no preference - both satisfactory' and 'no preference - both unsatisfactory' at jaw registration (Study Clinical Visit 3) 4. Patient assessment of the finished dentures for comfort using a 5-point Likert scale at denture fit (Study Clinical Visit 5) 5. Patient assessment of the finished dentures for stability using a 5-point Likert scale at denture fit (Study Clinical Visit 5) 6. Patient assessment of the finished dentures for aesthetics using a 5-point Likert scale at denture fit (Study Clinical Visit 5) 7. Reason given by the participant for their preferences for the dentures assessed using an open-ended question at denture fit (Study Clinical Visit 5)(to be analysed qualitatively) 8. Participant's opinion of the aesthetics of the dentures assessed using an open-ended question at denture fit (Study Clinical Visit 5) (to be analysed qualitatively)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026