AccuracyNCT06067334
Digital Impression Techniques of Full Arch Implant-supported Screw-retained Restoration
A study testing full arch implant supported screw retained restoration with conventional impression technique and full arch implant supported screw retained restoration with conventional digital technique in people with Accuracy, run by Mansoura University at 1 site in Egypt.
Trial summary
aim: to compare the accuracy of the conventional and digital impression when will be performed on implant level or abutment level in Complete digital workflow for construction of full arch implant supported screw-retained restoration. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Accuracy
- What is being tested?
- full arch implant supported screw retained restoration with conventional impression technique and full arch implant supported screw retained restoration with conventional digital technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 10 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
- Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
- Normal maxilla mandibular relationship with adequate inter-arch space as verified by tentative jaw relation.
- Sufficient residual alveolar ridge.
Who cannot join
- Local or general contraindications for surgical procedures.
- Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
- Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, mansoura university
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration: Accuracy of Different Impressions Techniques on Implant and Abutment Levels (Cross-over Study)
aim: to compare the accuracy of the conventional and digital impression when will be performed on implant level or abutment level in Complete digital workflow for construction of full arch implant supported screw-retained restoration.
Read the detailed description
The patient will be selected according to the following criteria:
- Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
- Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
- Normal maxilla mandibular relationship with adequate inter-arch space, measured by tentative jaw relation.
- Sufficient residual alveolar ridge.
Exclusion criteria include:
- Local or general contraindications for surgical procedures.
- Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
- Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
- Heavy smokers.
- For all patients, conventional complete dentures are constructed.
- Implants installed in the edentulous maxilla and mandible in each target position guided by stereolithographic stent. A delayed loading protocol is followed in this study.
- After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.
- Scan bodies' implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.
Accuracy will be evaluated as follows:
- 3D inspection software using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.
- Passive fit of the framework will be evaluated at the time of insertion.
- Conditions
- Accuracy
- Being tested
- full arch implant supported screw retained restoration with conventional impression technique, full arch implant supported screw retained restoration with conventional digital technique
- Keywords
- Accuracy, implant level impression, abutment level impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full arch implant supported screw retained restoration with conventional impression techniqueOther
surgical procedures: Implant installation Prosthetic procedures: Conventional impression fabrication of full arch implant supported screw-retained restoration evaluation: Accuracy, Passive fit
full arch implant supported screw retained restoration with conventional digital techniqueOther
surgical procedures: Implant installation Prosthetic procedures: Digital impression fabrication of full arch implant-supported screw-retained restoration evaluation: Accuracy, Passive fit
| Study group | Role | What they receive |
|---|---|---|
| Conventional (Open tray impression technique) | Active comparator | After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level. Receives: Other: full arch implant supported screw retained restoration with conventional impression technique |
| Digital impression | Active comparator | Scan bodies implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions. Receives: Other: full arch implant supported screw retained restoration with conventional digital technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best fit alignment to calculate 3D deviation of each impression
3D inspection software (Geomagic Control X) using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.
Measured: 3 months
Secondary outcomes (1)
Passive fit
Passive fit of framework will be evaluated at time of insertion (Sheffield test)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start20 Jul 2023
- Primary completion20 Nov 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccuracyStudies 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
- 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
- Principal investigator, Fatma mahanna, Mansoura University
- Investigators
- Ahmed Gamal, MD, Principal investigator, Mansoura university, faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067334
- Sponsor's protocol ID
- J0104023RP
- Status last verified
- Jan 2025
- First submitted
- 25 Sep 2023
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. 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: Accuracy of Different Impressions Techniques on Implant and Abutment Levels (Cross-over Study)
- ClinicalTrials.gov ID
- NCT06067334
- Acronym / sponsor ID
- J0104023RP
- Conditions
- Accuracy
- Keywords
- Accuracy, implant level impression, abutment level impression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 4 Oct 2023 (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.
aim: to compare the accuracy of the conventional and digital impression when will be performed on implant level or abutment level in Complete digital workflow for construction of full arch implant supported screw-retained restoration.
Detailed description
The patient will be selected according to the following criteria:
- Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
- Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
- Normal maxilla mandibular relationship with adequate inter-arch space, measured by tentative jaw relation.
- Sufficient residual alveolar ridge.
Exclusion criteria include:
- Local or general contraindications for surgical procedures.
- Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
- Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
- Heavy smokers.
- For all patients, conventional complete dentures are constructed.
- Implants installed in the edentulous maxilla and mandible in each target position guided by stereolithographic stent. A delayed loading protocol is followed in this study.
- After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.
- Scan bodies' implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.
Accuracy will be evaluated as follows:
- 3D inspection software using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.
- Passive fit of the framework will be evaluated at the time of insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional (Open tray impression technique) | Active comparator | Other: full arch implant supported screw retained restoration with conventional impression techniqueAfter osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level. |
| Digital impression | Active comparator | Other: full arch implant supported screw retained restoration with conventional digital techniqueScan bodies implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
- Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
- Normal maxilla mandibular relationship with adequate inter-arch space as verified by tentative jaw relation.
- Sufficient residual alveolar ridge.
Key exclusion criteria (4 listed)
- Local or general contraindications for surgical procedures.
- Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
- Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
- Heavy smokers.
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 |
|---|---|---|
| full arch implant supported screw retained restoration with conventional impression techniquesurgical procedures: Implant installation Prosthetic procedures: Conventional impression fabrication of full arch implant supported screw-retained restoration evaluation: Accuracy, Passive fit | Other | Conventional (Open tray impression technique) |
| full arch implant supported screw retained restoration with conventional digital techniquesurgical procedures: Implant installation Prosthetic procedures: Digital impression fabrication of full arch implant-supported screw-retained restoration evaluation: Accuracy, Passive fit | Other | Digital impression |
Primary outcome
Best fit alignment to calculate 3D deviation of each impression
Time frame: 3 months
3D inspection software (Geomagic Control X) using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.
1 secondary outcome
Passive fit
Time frame: 3 months
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 8 Oct 2026.
- 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.
Ahmed Gamal, MD principal investigator
Mansoura university, faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full arch implant supported screw retained restoration with conventional impression technique and full arch implant supported screw retained restoration with conventional digital technique in people with Accuracy, 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 4 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 8 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 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?
Best fit alignment to calculate 3D deviation of each impression (time frame: 3 months). 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 8 Oct 2026.