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Digital versus traditional full dentures – does the new technology feel better? A patient-centred pilot study

Patient satisfaction and perception with digital complete dentures compared to conventional complete dentures: a randomized crossover pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88250752
Enrollment
40
Registered
2025-05-29
Start date
2024-02-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Oral healthcare for edentulous patients Oral Health

Interventions

A prospective, randomized crossover clinical trial was conducted in 2023–2024 involving 40 completely maxillary edentulous patients meeting specific inclusion criteria. The two prosthetic restorations
however, a 1-2 week adaptation period was allowed with the new prosthesis before data collection at each crossover point. Importantly, each patient received new maxillary dentures fabricated by both m

Sponsors

Dentexpert Private Practice SRL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients included in this study had varying conditions in the opposing mandibular arch, including complete dentures (45%), removable partial dentures (35%) or fixed prosthetic restorations (20%). The presence of different mandibular arch conditions was considered when analyzing the results, as it may influence satisfaction with the maxillary dentures. 2. All participants signed an informed consent form that included a description of the intervention.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled systemic disease 2. Infectious diseases 3. Partial maxillary edentulism 4. Temporo-mandibular disorders 5. Xerostomia 6. Oro-facial pain 7. Patients who could not read informed consent form 8. Patients with congenital or acquired defects in maxilla and/or mandible 9. Patients considered ineligible for study inclusion by the principal investigator

Design outcomes

Primary

MeasureTime frame
Patient comfort measured using Item 1, 10-item Patient Satisfaction Questionnaire (PSQ), 5-point Likert at 6 months (T1) and 12 months (T2)

Secondary

MeasureTime frame
1. Retention measured using Item 6, PSQ at T1 and T2 2. Mastication measured using Item 5, PSQ at T1 and T2 3. Post-insertion adjustment visits measured using clinic records at T1 and T2 4. Overall denture preference measured using single forced-choice question at T2

Countries

Romania

Contacts

Public ContactAndreea Bors
andrea.bors@umfst.ro+40 (0)722649493

Outcome results

None listed

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