Prosthesis (Internal) ComplicationsNCT07489027
Comparison of Prosthetic Complications and Framework Misfit Among Different Cobalt-Chromium Framework Fabrication Techniques
A study testing Implant supported prosthesis in people with Prosthesis (Internal) Complications, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized clinical study aimed to compare prosthetic complications and framework misfit associated with three different fabrication techniques of cobalt-chromium frameworks-conventional casting, CAD/CAM milling, and selective laser melting (SLM)-used in maxillary and mandibular full-arch implant-supported… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis (Internal) Complications
- What is being tested?
- Implant supported prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2024to 15 Feb 2026
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Six osseointegrated maxillary and six mandibular implants
- No clinical or radiographic signs of implant failure
- Good systemic health
- Normal maxillomandibular relationship and acceptable oral hygiene
Who cannot join
- • Implant failure
- Unfavorable occlusal relationships
- Poor compliance or inability to attend follow-up
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University , Faculty Of Dentistry
Al Mansurah, Dakahlia Governorate, P.O.Box:35516
About this study
Official title: Comparison of Prosthetic Complications and Framework Misfit Among Different Cobalt-Chromium Framework Fabrication Techniques in Maxillary and Mandibular Full-Arch Implant-Supported Acrylic Screw-Retained Restorations: A Randomized Clinical Study
This randomized clinical study aimed to compare prosthetic complications and framework misfit associated with three different fabrication techniques of cobalt-chromium frameworks-conventional casting, CAD/CAM milling, and selective laser melting (SLM)-used in maxillary and mandibular full-arch implant-supported acrylic screw-retained restorations.
- Conditions
- Prosthesis (Internal) Complications
- Being tested
- Implant supported prosthesis
- Keywords
- Full arch prosthesis, Co-Cr framework, CAD/CAM milling, Selective laser melting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant supported prosthesisDevice
All patients received maxillary and mandibular six implants to support a metal acrylic screw retained full-arch prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Group I: Conventional cast Co-Cr framework | Active comparator | patients received maxillary and mandibular full-arch implant fixed prosthesis with conventional casting CO-CR framework Receives: Device: Implant supported prosthesis |
| Group II: CAD/CAM milled Co-Cr framework | Active comparator | patients received maxillary and mandibular full-arch implant fixed prosthesis with milled CO-CR framework Receives: Device: Implant supported prosthesis |
| Group III: Selective laser melting (SLM) Co-Cr framework | Active comparator | patients received maxillary and mandibular full-arch implant fixed prosthesis with a laser-melted CO-CR framework. Receives: Device: Implant supported prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of occurance of Prosthetic complications
The prosthetic complications were evaluated for the three different types of Co-Cr frameworks
The following prosthetic complications were evaluated:
- abutment screw loosening
- abutment screw fracture
- prosthetic screw loosening
- prosthetic screw fracture
- acrylic teeth fracture (separation)
- acrylic teeth wear (replacement)
- co-cr framework fracture
Measured: after a year
Secondary outcomes (1)
the implant framework Passive fit
the passivity of the framework was evaluated digitally using 3D scan protocol
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start18 Jan 2024
- Primary completion6 Nov 2024
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis (Internal) ComplicationsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly allocated to three equal groups (n = 9) by simple randomization:Group I: Conventional cast Co-Cr framework, Group II: CAD/CAM milled Co-Cr framework, and Group III: SLM Co-Cr framework
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489027
- Sponsor's protocol ID
- A05012023RP
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prosthetic Complications and Framework Misfit Among Different Cobalt-Chromium Framework Fabrication Techniques in Maxillary and Mandibular Full-Arch Implant-Supported Acrylic Screw-Retained Restorations: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07489027
- Acronym / sponsor ID
- A05012023RP
- Conditions
- Prosthesis (Internal) Complications
- Keywords
- Full arch prosthesis, Co-Cr framework, CAD/CAM milling, Selective laser melting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 23 Mar 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 randomized clinical study aimed to compare prosthetic complications and framework misfit associated with three different fabrication techniques of cobalt-chromium frameworks-conventional casting, CAD/CAM milling, and selective laser melting (SLM)-used in maxillary and mandibular full-arch implant-supported acrylic screw-retained restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients were randomly allocated to three equal groups (n = 9) by simple randomization:Group I: Conventional cast Co-Cr framework, Group II: CAD/CAM milled Co-Cr framework, and Group III: SLM Co-Cr framework
| Arm | Type | Receives |
|---|---|---|
| Group I: Conventional cast Co-Cr framework | Active comparator | Device: Implant supported prosthesispatients received maxillary and mandibular full-arch implant fixed prosthesis with conventional casting CO-CR framework |
| Group II: CAD/CAM milled Co-Cr framework | Active comparator | Device: Implant supported prosthesispatients received maxillary and mandibular full-arch implant fixed prosthesis with milled CO-CR framework |
| Group III: Selective laser melting (SLM) Co-Cr framework | Active comparator | Device: Implant supported prosthesispatients received maxillary and mandibular full-arch implant fixed prosthesis with a laser-melted CO-CR framework. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Six osseointegrated maxillary and six mandibular implants
Key exclusion criteria (3 listed)
- • Implant failure
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 |
|---|---|---|
| Implant supported prosthesisAll patients received maxillary and mandibular six implants to support a metal acrylic screw retained full-arch prosthesis | Device | Group I: Conventional cast Co-Cr framework, Group II: CAD/CAM milled Co-Cr framework, Group III: Selective laser melting (SLM) Co-Cr framework |
Primary outcome
the number of occurance of Prosthetic complications
Time frame: after a year
The prosthetic complications were evaluated for the three different types of Co-Cr frameworks The following prosthetic complications were evaluated: * abutment screw loosening * abutment screw fracture * prosthetic screw loosening * prosthetic screw fracture * acrylic teeth fracture (separation) * acrylic teeth wear (replacement) * co-cr framework fracture
1 secondary outcome
the implant framework Passive fit
Time frame: baseline
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 23 Mar 2026.
- 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 Implant supported prosthesis in people with Prosthesis (Internal) Complications, run by Mansoura 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 4 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: finished, as of the sponsor's last update on 23 Mar 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 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?
the number of occurance of Prosthetic complications (time frame: after a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.