DentureNCT06412159
Digital Evaluation of Accuracy for Removable Partial Denture Frameworks
A study testing Selective laser melting framework was fabricated using completely digital workflow in people with Denture and Partial, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Purpose:Within subject study aim to compare the overall accuracy and fit of different components for mandibular metallic removable partial denture (RPD) frameworks fabricated by selective laser melting using combined analog-digital, and fully digital impression techniques. Material and methods. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- What is being tested?
- Selective laser melting framework was fabricated using completely digital workflow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department
Who cannot join
- other classes of removable partial denture maxillary partially edentulous patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-oral Digital Evaluation of Fit Accuracy for Removable Partial Denture Frameworks Fabricated by Selective Laser Melting Using 2 Different Impression Techniques. Within Subjected Study
Purpose:Within subject study aim to compare the overall accuracy and fit of different components for mandibular metallic removable partial denture (RPD) frameworks fabricated by selective laser melting using combined analog-digital, and fully digital impression techniques.
Material and methods. Two RPD frameworks were fabricated for each of the 24 participants using each of the 2 techniques of the 24 participants enrolled, were of mandibular Kennedy class I, the first technique was the combined analog-digital workflow had the analog steps include: a physical impression was made using polyvinyl siloxane, stone casts were made, then the stone cast was scanned with a laboratory scanner to generate a digital cast. The 3Shape CAD software was then used to design a digital RPD, which was fabricated from a cobalt-chroumum alloy by selective laser melting. The second technique was fully digital where an intraoral digital scanner was used to make a definitive scan, which was sent to the 3Shape software for digitally designing the RPD framework and subsequent selective laser melting for fabrication. For both frameworks in the same participant, the same design was used for consistency. To assess the accuracy of fit, based on STL data analysis (intra-oral digital superimposition evaluation), a color map was constructed using non metrology software, and overall fit accuracy and the misfit (distance between each framework component and the reference intra-oral scan) were measured at rest, guiding plane and lingual plate areas.
Read the detailed description
Twenty four mandibular bilateral partially edentulous participants aged from 50 to 65 years having mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department. The clinical study was explained to the patients and they accept it and an informed consent were signed by all them
For each patient, two different cobalt chromium removable partial denture frameworks were constructed; the first one was fabricated using combined analog-digital workflow (group 1) and the other framework was fabricated using completely digital workflow (group 2) and comparing them through evaluation of:
- Over all accuracy
- Accuracy of fit of occlusal rests, major connector, Guiding plane/plate relation and retentive terminal of I bar clasp.
Two techniques were used to fabricate 48 RPD frameworks in total. Fabrication of cobalt chromium removable partial denture framework using combined analog-digital workflow (group 1)
The Removable partial denture frameworks for group 1 were fabricated as follow:
The first technique was a combined analog-digital technique, in which a physical definitive impression was made and a stone cast was fabricated. a physical impression was made using polyvinyl siloxane impression material. , and a stone cast was poured using Type IV stone . In an edentulous area, border molding was first accomplished using a green modeling plastic impression compound . The impression and stone cast were evaluated critically to ensure quality. The stone cast was then scanned using a laboratory scanner to produce a virtual 3D master model. The 3Shape CAD software was used to design a digital RPD . The RPD framework was designed with an lingual plate mandibular major connector, I bar retentive clasps on the first premolars.
The definitive STL design file was then sent to the Dental Laboratory, to be selective laser melted in Co-Cr alloy.
The Overall fit accuracy and the misfit at some areas where the accuracy measurement was performed, included: The rest/rest seat areas of right and left premolars , the right and left guide plane/plate area , the mandibular major connector area including the superior border of lingual plate area and retentive terminal of I bar clasp.
All measurements were made by a single investigator and were repeated five times. The average error of measurement was approximately 0.002 mm. As a basis for our evaluation of misfit, a distance of 0 to 0.05 mm was considered close contact (no gap), and a distance of 0.05 to 0.31 mm was defined as clinically acceptable fit.
- Being tested
- Selective laser melting framework was fabricated using completely digital workflow
- Keywords
- partial denture, intra oral, digital evaluation, accuracy, selective laser melting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective laser melting framework was fabricated using completely digital workflowOther
completely digital work flow Conventional technique versus complete digital technique
| Study group | Role | What they receive |
|---|---|---|
| selective laser melting removable partial denture frameworks fabricated by conventional technique | Other | selective laser melting removable partial denture frameworks fabricated by conventional technique Receives: Other: Selective laser melting framework was fabricated using completely digital workflow |
| selective laser melting framework was fabricated using completely digital workflow | Other | selective laser melting framework was fabricated using completely digital workflow Receives: Other: Selective laser melting framework was fabricated using completely digital workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-oral digital Evaluation of fit accuracy for removable partial denture frameworks
Intra-oral digital Accuracy of fit evaluation between frame works by using medit compare software to exclude the value of point difference in different area at occlusal rest major connector
Measured: immediately after insertion of removable partial denture frame work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jan 2023
- Primary completion1 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DentureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Ragheb, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412159
- Sponsor's protocol ID
- KFSIRB200-130
- Status last verified
- Sep 2024
- First submitted
- 3 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-oral Digital Evaluation of Fit Accuracy for Removable Partial Denture Frameworks Fabricated by Selective Laser Melting Using 2 Different Impression Techniques. Within Subjected Study
- ClinicalTrials.gov ID
- NCT06412159
- Acronym / sponsor ID
- KFSIRB200-130
- Keywords
- partial denture, intra oral, digital evaluation, accuracy, selective laser melting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 14 May 2024 (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.
Purpose:Within subject study aim to compare the overall accuracy and fit of different components for mandibular metallic removable partial denture (RPD) frameworks fabricated by selective laser melting using combined analog-digital, and fully digital impression techniques.
Material and methods. Two RPD frameworks were fabricated for each of the 24 participants using each of the 2 techniques of the 24 participants enrolled, were of mandibular Kennedy class I, the first technique was the combined analog-digital workflow had the analog steps include: a physical impression was made using polyvinyl siloxane, stone casts were made, then the stone cast was scanned with a laboratory scanner to generate a digital cast. The 3Shape CAD software was then used to design a digital RPD, which was fabricated from a cobalt-chroumum alloy by selective laser melting. The second technique was fully digital where an intraoral digital scanner was used to make a definitive scan, which was sent to the 3Shape software for digitally designing the RPD framework and subsequent selective laser melting for fabrication. For both frameworks in the same participant, the same design was used for consistency. To assess the accuracy of fit, based on STL data analysis (intra-oral digital superimposition evaluation), a color map was constructed using non metrology software, and overall fit accuracy and the misfit (distance between each framework component and the reference intra-oral scan) were measured at rest, guiding plane and lingual plate areas.
Detailed description
Twenty four mandibular bilateral partially edentulous participants aged from 50 to 65 years having mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department. The clinical study was explained to the patients and they accept it and an informed consent were signed by all them
For each patient, two different cobalt chromium removable partial denture frameworks were constructed; the first one was fabricated using combined analog-digital workflow (group 1) and the other framework was fabricated using completely digital workflow (group 2) and comparing them through evaluation of:
- Over all accuracy
- Accuracy of fit of occlusal rests, major connector, Guiding plane/plate relation and retentive terminal of I bar clasp.
Two techniques were used to fabricate 48 RPD frameworks in total. Fabrication of cobalt chromium removable partial denture framework using combined analog-digital workflow (group 1)
The Removable partial denture frameworks for group 1 were fabricated as follow:
The first technique was a combined analog-digital technique, in which a physical definitive impression was made and a stone cast was fabricated. a physical impression was made using polyvinyl siloxane impression material. , and a stone cast was poured using Type IV stone . In an edentulous area, border molding was first accomplished using a green modeling plastic impression compound . The impression and stone cast were evaluated critically to ensure quality. The stone cast was then scanned using a laboratory scanner to produce a virtual 3D master model. The 3Shape CAD software was used to design a digital RPD . The RPD framework was designed with an lingual plate mandibular major connector, I bar retentive clasps on the first premolars.
The definitive STL design file was then sent to the Dental Laboratory, to be selective laser melted in Co-Cr alloy.
The Overall fit accuracy and the misfit at some areas where the accuracy measurement was performed, included: The rest/rest seat areas of right and left premolars , the right and left guide plane/plate area , the mandibular major connector area including the superior border of lingual plate area and retentive terminal of I bar clasp.
All measurements were made by a single investigator and were repeated five times. The average error of measurement was approximately 0.002 mm. As a basis for our evaluation of misfit, a distance of 0 to 0.05 mm was considered close contact (no gap), and a distance of 0.05 to 0.31 mm was defined as clinically acceptable fit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selective laser melting removable partial denture frameworks fabricated by conventional technique | Other | Other: Selective laser melting framework was fabricated using completely digital workflowselective laser melting removable partial denture frameworks fabricated by conventional technique |
| selective laser melting framework was fabricated using completely digital workflow | Other | Other: Selective laser melting framework was fabricated using completely digital workflowselective laser melting framework was fabricated using completely digital workflow |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department
Key exclusion criteria (1 listed)
- other classes of removable partial denture maxillary partially edentulous patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective laser melting framework was fabricated using completely digital workflowcompletely digital work flow Conventional technique versus complete digital technique | Other | selective laser melting framework was fabricated using completely digital workflow, selective laser melting removable partial denture frameworks fabricated by conventional technique |
Primary outcome
Intra-oral digital Evaluation of fit accuracy for removable partial denture frameworks
Time frame: immediately after insertion of removable partial denture frame work
Intra-oral digital Accuracy of fit evaluation between frame works by using medit compare software to exclude the value of point difference in different area at occlusal rest major connector
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: 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: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective laser melting framework was fabricated using completely digital workflow in people with Denture and Partial, run by Kafrelsheikh University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-oral digital Evaluation of fit accuracy for removable partial denture frameworks (time frame: immediately after insertion of removable partial denture frame work). 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 NCT06412159, which also lists 1 linked publication.
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 19 Sep 2024.