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Not yet recruitingNCT07903662DIGICLASPUpdated Oct 29, 2026

Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)

An observational study in Partial Edentulism, sponsored by University of Bern. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by University of Bern · Observational

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

This single-center prospective observational cohort study evaluates two fabrication workflows already in routine clinical use for clasp-retained removable partial dentures (RPDs): a digital workflow (Group 1) and a conventional workflow (Group 2). The fabrication workflow is selected as part of routine clinical care and is not assigned by the study. Separately for the digital and conventional workflows, the study describes the cumulative active clinical chairside time (primary), together with the number of clinical appointments, dental laboratory process times, quantitative and clinical framework fit, adjustment effort, final fit, and the frequency of rework and remake. Consecutive patients treated at the Department of Reconstructive Dentistry and Gerodontology, University of Bern, are included over a 36-month period. The analysis is purely descriptive; no causal inference, confirmatory hypothesis testing, or superiority assessment is planned.

Read the detailed description

Clasp-retained removable partial dentures are a frequent routine treatment at the Department of Reconstructive Dentistry and Gerodontology, University of Bern, including the undergraduate student course; approximately 100 are produced per year. Both a conventional workflow and a digital workflow are used in routine care. For internal process control, systematic prospective data on process efficiency, framework fit, adjustment effort, and rework or remake are currently lacking for these routinely used workflows.

This is a single-center, prospective, observational cohort study embedded in routine care. The fabrication workflow (digital = Group 1; conventional = Group 2) is chosen clinically as part of regular treatment and is not assigned, randomized, or otherwise influenced by the study; the workflow actually used is documented prospectively. An approximately balanced representation of both workflows and Kennedy classes is sought over the data-collection period, but no fixed allocation rule or quota is applied. No causal or superiority comparison between workflows is intended.

The only study-specific procedure is two additional, non-invasive intraoral scans performed during the already-scheduled framework try-in: one scan without the framework and one with the fully seated framework. For the second scan, an intraorally approved scan spray is applied to visible metal surfaces and removed afterwards. The two scans together take about 10 minutes and require no additional appointment. In addition, the finished framework is scanned extraorally in the laboratory as a reference, which adds no patient time. All other examinations and treatment steps are part of routine care.

Outcomes are described separately per workflow and setting using descriptive statistics. No sample-size calculation and no confirmatory hypothesis testing are performed.

02

Conditions studied

  • Partial Edentulism

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Keywords

  • Jaw
  • Edentulous
  • Partially
03

In context

Mouth, Edentulous

124 studies on the registry are indexed under Mouth, Edentulous; 17 are open to participants now.

This study's planned enrollment of 70 is above the median of 59 across 27 observational studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients with an indication for a clasp-retained removable partial denture treated at the Department of Reconstructive Dentistry and Gerodontology, University of Bern (clinical, postgraduate and undergraduate student-course settings), during the data-collection period who consent to the two additional intraoral scans.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older
  • Indication for a clasp-retained removable partial denture, treated at the department during the data-collection period
  • Consent to the two additional, non-invasive intraoral scans performed during the framework try-in

Exclusion criteria

Exclusion Criteria:

  • No consent to the study-specific additional measures
  • Minors
  • Persons unable to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Digital workflow

    Patients whose clasp-retained RPD is fabricated using the digital workflow (intraoral scan-based CAD and digital framework fabrication) as selected in routine clinical care. Group membership reflects the clinically chosen fabrication workflow and is not assigned by the study.

  • Conventional workflow

    Patients whose clasp-retained RPD is fabricated using the conventional workflow as selected in routine clinical care. Group membership reflects the clinically chosen fabrication workflow and is not assigned by the study.

06

What researchers measure

Primary outcomes

  1. Cumulative active prosthesis-related clinical chairside time

    Cumulative active prosthesis-related clinical chairside time per participant, in minutes, summed across all treatment sessions from the first prosthesis-related appointment to definitive insertion. Includes regular clinical scanning required for fabrication, framework try-in and clinical adjustment, if required. Excludes waiting and interruption time, study-specific scanning procedures and framework planning/drawing. Reported separately for the digital and conventional fabrication workflows.

    Time frame: From the first prosthesis-related appointment through definitive insertion, an average of 6 weeks per participant.

Secondary outcomes

  1. Number of clinical appointments

    Number of clinical appointments per participant from the first prosthesis-related appointment to definitive insertion. Reported separately per workflow.

    Time frame: Through completion of prosthetic treatment, an average of 6 weeks.

  2. Active dental laboratory technician time

    Active dental laboratory technician working time per participant, in minutes, recorded for predefined fabrication steps; idle time between steps is excluded. Reported separately per workflow.

    Time frame: From receipt of the laboratory order to completion of framework fabrication, approximately 3-4 weeks after treatment initiation.

  3. Quantitative framework fit

    Three-dimensional surface distance between supporting tooth/ridge surfaces and the framework fitting surface, in micrometers, in predefined measurement regions, based on superimposition of an intraoral scan without the framework, an intraoral scan with the seated framework and an extraoral scan of the finished framework. Continuous measure; no clinical cut-off. Reported separately per workflow.

    Time frame: At initial framework try-in, approximately 3-4 weeks after treatment initiation, before clinical adjustment.

  4. Number of participants whose framework meets all clinical fit and stability criteria before adjustment

    Four predefined yes/no criteria: seating of rests; adaptation of clasps and tooth-contacting components; adaptation of the major connector; stability under bilateral finger pressure. Reported separately per workflow.

    Time frame: At framework try-in, approximately 3-4 weeks after treatment initiation, before clinical adjustment.

  5. Number of participants whose framework requires clinical adjustment

    Whether clinical adjustment of the framework is required (yes/no). Reported separately per workflow.

    Time frame: At framework try-in, approximately 3-4 weeks after treatment initiation.

  6. Active clinical adjustment time

    Active clinical adjustment time per participant, in minutes, including participants without adjustment (0 minutes). Reported separately per workflow.

    Time frame: At framework try-in, approximately 3-4 weeks after treatment initiation.

  7. Number of participants with clinically acceptable final framework fit

    Number of participants whose framework demonstrates clinically acceptable final fit (yes/no), assessed after completion of framework try-in and clinical adjustment, if required. Reported separately per workflow.

    Time frame: At completion of framework try-in, approximately 3-4 weeks after treatment initiation.

  8. Number of participants whose framework requires laboratory rework

    Rework documented with predefined cause categories. Reported separately per workflow.

    Time frame: Through completion of prosthetic treatment, an average of 6 weeks.

  9. Number of participants whose framework requires complete remake

    Remake documented with predefined cause categories. Reported separately per workflow.

    Time frame: Through completion of prosthetic treatment, an average of 6 weeks.

  10. Total invoiced treatment cost

    Total invoiced treatment cost per participant, in Swiss francs (CHF): invoiced prosthesis-related clinical services plus dental laboratory costs from treatment initiation to definitive insertion; unrelated dental services excluded. Restricted to participants treated in the specialist (non-student-course) setting. Reported separately per workflow.

    Time frame: Through completion of prosthetic treatment, an average of 6 weeks.

  11. Estimated personnel-related process cost

    Estimated personnel-related process cost per participant, in Swiss francs (CHF): prospectively recorded active clinical and dental laboratory working times multiplied by predefined personnel cost rates (separate rates for clinical and dental laboratory time). Restricted to participants treated in the specialist (non-student-course) setting. Reported separately per workflow.

    Time frame: Through completion of prosthetic treatment, an average of 6 weeks.

07

Study locations

1 site
08

References and documents

Publications

  • Almufleh B, Arellanob A, Tamimi F. Patient-reported outcomes and framework fit accuracy of removable partial dentures fabricated using digital techniques: A systematic review and meta-analysis. J Prosthodont. 2024 Aug;33(7):626-636. doi: 10.1111/jopr.13786. Epub 2023 Nov 20. PubMed 37930081 ↗
  • Chia VAP, See Toh YL, Quek HC, Pokharkar Y, Yap AU, Yu N. Comparative clinical evaluation of removable partial denture frameworks fabricated traditionally or with selective laser melting: A randomized controlled trial. J Prosthet Dent. 2024 Jan;131(1):42-49. doi: 10.1016/j.prosdent.2021.12.021. Epub 2022 Mar 5. PubMed 35260255 ↗
  • Tregerman I, Renne W, Kelly A, Wilson D. Evaluation of removable partial denture frameworks fabricated using 3 different techniques. J Prosthet Dent. 2019 Oct;122(4):390-395. doi: 10.1016/j.prosdent.2018.10.013. Epub 2019 Apr 1. PubMed 30948301 ↗
  • Elgamal M, Ibrahim AM, Fadl BT, Ragheb NA. Accuracy assessment of removable partial denture frameworks fabricated by selective laser melting using two different workflows: A cross-over clinical study. BMC Oral Health. 2025 May 28;25(1):824. doi: 10.1186/s12903-025-06214-9. PubMed 40437453 ↗

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared. The data-protection framework of this internal quality-control project does not provide for unrestricted public sharing of coded participant-level data. Aggregated results will be published in a peer-reviewed journal.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903662
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Mar 2030 (estimated)
Last update
Oct 29, 2026

Study contacts

Sebastian Hinz, Dr. med. dent.
Contact
sebastian.hinz@unibe.ch
+41 31 684 07 41
Nicole Schenk, Dr. med. dent.
Contact
nicole.schenk@unibe.ch
+41 31 684 07 39
Sebastian Hinz, Dr. med. dent.
principal investigator · University of Bern, Department of Reconstructive Dentistry and Gerodontology
Martin Schimmel, Prof. Dr. med. dent.
study chair · University of Bern, Department of Reconstructive Dentistry and Gerodontology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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