Prosthesis DurabilityNCT06332482
Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration
A study testing Implant supported screw retained prosthesis in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- Implant supported screw retained prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to 20 Dec 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Inclusion criteria: i- complete maxillary and mandibular edentulous arches ii- residual alveolar ridges covered with healthy firmly attached mucosa. iii- Angel's class I maxillo-mandibular relationship and iv- Adequate bone height and width for placement of standard diameter implants.
Who cannot join
- History of drug administration that interfere with bone quality ii- Surgical contraindication (patients under anticoagulant ,immunosuppressive drugs, chemotherapy and irradiation therapy) iv- tempromandibular or myoneurological disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University ,Faculty of dentistry
Al Mansurah, P.O.Box:35516
About this study
Official title: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration :occlusal Accuracy of Different Techniques Used to Record Maxillo-mandibular Relationship(Crossover Study)
This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration.
- Conditions
- Prosthesis Durability
- Being tested
- Implant supported screw retained prosthesis
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant supported screw retained prosthesisDevice
All patients will receive six maxillary and mandibular implants for full arch screw retained prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients who will use surgical stent in recording the digital Jaw relation Receives: Device: Implant supported screw retained prosthesis |
| Group 2 | Active comparator | Patients who will use acrylic complete denture in recording the digital Jaw relation Receives: Device: Implant supported screw retained prosthesis |
| Group 3 | Active comparator | Patients who will use mandibular stent in recording the digital Jaw relation Receives: Device: Implant supported screw retained prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of occlusal prematurity
Occlusal prematureties of final prosthesis will be measured using occlusense device
Measured: one year
prosthestic complications
prosthetic complications will be recorded for all patients and statistically analyzed
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start30 Mar 2023
- Primary completion20 May 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies 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
- Crossover
- Model description
- digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 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
- NCT06332482
- Sponsor's protocol ID
- M0303023RP
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration :occlusal Accuracy of Different Techniques Used to Record Maxillo-mandibular Relationship(Crossover Study)
- ClinicalTrials.gov ID
- NCT06332482
- Acronym / sponsor ID
- M0303023RP
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Mar 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.
This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Implant supported screw retained prosthesisPatients who will use surgical stent in recording the digital Jaw relation |
| Group 2 | Active comparator | Device: Implant supported screw retained prosthesisPatients who will use acrylic complete denture in recording the digital Jaw relation |
| Group 3 | Active comparator | Device: Implant supported screw retained prosthesisPatients who will use mandibular stent in recording the digital Jaw relation |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Inclusion criteria: i- complete maxillary and mandibular edentulous arches ii- residual alveolar ridges covered with healthy firmly attached mucosa. iii- Angel's class I maxillo-mandibular relationship and iv- Adequate bone height and width for placement of standard diameter implants.
Key exclusion criteria (1 listed)
- History of drug administration that interfere with bone quality ii- Surgical contraindication (patients under anticoagulant ,immunosuppressive drugs, chemotherapy and irradiation therapy) iv- tempromandibular or myoneurological disorders.
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 screw retained prosthesisAll patients will receive six maxillary and mandibular implants for full arch screw retained prosthesis | Device | Group 1, Group 2, Group 3 |
Primary outcome
measurement of occlusal prematurity
Time frame: one year
Occlusal prematureties of final prosthesis will be measured using occlusense device
prosthestic complications
Time frame: one year
prosthetic complications will be recorded for all patients and statistically analyzed
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 17 Jan 2025.
- Individual participant dataSharing planned: No
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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 screw retained prosthesis in people with Prosthesis Durability, 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 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 17 Jan 2025. 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?
measurement of occlusal prematurity (time frame: one year). The study lists 2 primary outcomes in all. 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 17 Jan 2025.