Partial EdentulismDIGICLASPNCT07903662
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
An observational study of Partial Edentulism, run by University of Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2026to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No consent to the study-specific additional measures
- Minors
- Persons unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Bern, Canton of Bern, 3010
Sebastian Hinz, Dr. med. dent., +41 31 68407 41, sebastian.hinz@unibe.ch
Nicole Schenk, Dr. med. dent., +41 31 684 0739, nicole.schenk@unibe.ch
About this study
Official title: Digital and Conventional Fabrication of Clasp-retained Removable Partial Dentures: A Prospective Observational Evaluation of Clinical and Dental Laboratory Processes
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.
- Conditions
- Partial Edentulism
- Keywords
- Jaw, Edentulous, Partially
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first prosthesis-related appointment through definitive insertion, an average of 6 weeks per participant.
Secondary outcomes (11)
Number of clinical appointments
Number of clinical appointments per participant from the first prosthesis-related appointment to definitive insertion. Reported separately per workflow.
Measured: Through completion of prosthetic treatment, an average of 6 weeks.
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.
Measured: From receipt of the laboratory order to completion of framework fabrication, approximately 3-4 weeks after treatment initiation.
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.
Measured: At initial framework try-in, approximately 3-4 weeks after treatment initiation, before clinical adjustment.
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.
Measured: At framework try-in, approximately 3-4 weeks after treatment initiation, before clinical adjustment.
Number of participants whose framework requires clinical adjustment
Whether clinical adjustment of the framework is required (yes/no). Reported separately per workflow.
Measured: At framework try-in, approximately 3-4 weeks after treatment initiation.
Active clinical adjustment time
Active clinical adjustment time per participant, in minutes, including participants without adjustment (0 minutes). Reported separately per workflow.
Measured: At framework try-in, approximately 3-4 weeks after treatment initiation.
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.
Measured: At completion of framework try-in, approximately 3-4 weeks after treatment initiation.
Number of participants whose framework requires laboratory rework
Rework documented with predefined cause categories. Reported separately per workflow.
Measured: Through completion of prosthetic treatment, an average of 6 weeks.
Number of participants whose framework requires complete remake
Remake documented with predefined cause categories. Reported separately per workflow.
Measured: Through completion of prosthetic treatment, an average of 6 weeks.
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.
Measured: Through completion of prosthetic treatment, an average of 6 weeks.
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.
Measured: Through completion of prosthetic treatment, an average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Hinz, Dr. med. dent., Principal investigator, University of Bern, Department of Reconstructive Dentistry and GerodontologyMartin Schimmel, Prof. Dr. med. dent., Study chair, University of Bern, Department of Reconstructive Dentistry and Gerodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903662
- Sponsor's protocol ID
- DIGICLASP
- Other IDs
- Req-2026-01413
- Acronym
- DIGICLASP
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 37930081Chia 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 35260255Tregerman 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 30948301Elgamal 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital and Conventional Fabrication of Clasp-retained Removable Partial Dentures: A Prospective Observational Evaluation of Clinical and Dental Laboratory Processes
- ClinicalTrials.gov ID
- NCT07903662
- Acronym / sponsor ID
- DIGICLASP / DIGICLASP
- Conditions
- Partial Edentulism
- Keywords
- Jaw, Edentulous, Partially
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- No consent to the study-specific additional measures
- Minors
- Persons unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative active prosthesis-related clinical chairside time
Time frame: From the first prosthesis-related appointment through definitive insertion, an average of 6 weeks per participant.
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.
11 secondary outcomes
Number of clinical appointments
Time frame: Through completion of prosthetic treatment, an average of 6 weeks.
Active dental laboratory technician time
Time frame: From receipt of the laboratory order to completion of framework fabrication, approximately 3-4 weeks after treatment initiation.
Quantitative framework fit
Time frame: At initial framework try-in, approximately 3-4 weeks after treatment initiation, before clinical adjustment.
Number of participants whose framework meets all clinical fit and stability criteria before adjustment
Time frame: At framework try-in, approximately 3-4 weeks after treatment initiation, before clinical adjustment.
Number of participants whose framework requires clinical adjustment
Time frame: At framework try-in, approximately 3-4 weeks after treatment initiation.
Active clinical adjustment time
Time frame: At framework try-in, approximately 3-4 weeks after treatment initiation.
Number of participants with clinically acceptable final framework fit
Time frame: At completion of framework try-in, approximately 3-4 weeks after treatment initiation.
Number of participants whose framework requires laboratory rework
Time frame: Through completion of prosthetic treatment, an average of 6 weeks.
Number of participants whose framework requires complete remake
Time frame: Through completion of prosthetic treatment, an average of 6 weeks.
Total invoiced treatment cost
Time frame: Through completion of prosthetic treatment, an average of 6 weeks.
Estimated personnel-related process cost
Time frame: Through completion of prosthetic treatment, an average of 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 37930081Almufleh 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.
- Background: PubMed 35260255Chia 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.
- Background: PubMed 30948301Tregerman 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.
- Background: PubMed 40437453Elgamal 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.
- Individual participant dataSharing planned: 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.
Related trials for Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Recruiting
Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
Partial Edentulism, Dental Implant Placement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Edentulism, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Hinz, Dr. med. dent. (+41 31 684 07 41, sebastian.hinz@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative active prosthesis-related clinical chairside time (time frame: From the first prosthesis-related appointment through definitive insertion, an average of 6 weeks per participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903662, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.