Complete EdentulismNCT07211022
Accuracy of Complete-Arch Implant Digital Impressions Using Photogrammetry and Intraoral Scanning
A study testing Digital impression using intraoral scanner, Digital impression using intraoral photogrammetry and Conventional impression in people with Complete Edentulism, run by Aldent University at 1 site in Albania.
Trial summary
This clinical study evaluates and compares the accuracy (trueness and precision) of intraoral photogrammetry and intraoral scanning for complete-arch implant-supported prostheses in patients initially treated according to All-on-4 or All-on-6 concepts. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Digital impression using intraoral scanner, Digital impression using intraoral photogrammetry and Conventional impression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAlbania
- Study dates
- 25 Oct 2025to 25 Mar 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years
- Edentulous maxilla or mandible
- All-on-4 or All-on-6 implant supported restoration
- Ability to provide informed consent
Who cannot join
- Severe systemic diseases (ASA III+)
- Bisphosphonate therapy
- Heavy bruxism
- Inability to attend follow-up
Trial locations and contacts
1 site in 1 country.
Albania1 site
University Dental Clinic of Aldent University
Tirana, Albania, 1017
About this study
Official title: Clinical Evaluation of the Complete Arch Digital Impressions Accuracy Using Photogrammetry and Intraoral Scanning
This clinical study evaluates and compares the accuracy (trueness and precision) of intraoral photogrammetry and intraoral scanning for complete-arch implant-supported prostheses in patients initially treated according to All-on-4 or All-on-6 concepts. Conventional impressions serve as the reference for assessing trueness. One patient initially treated with six implants lost one implant before impression acquisition and was therefore evaluated with five remaining implants.
Read the detailed description
The study aims to evaluate and compare two digital impression techniques, intraoral scanning and intraoral photogrammetry methods in terms of precision, accuracy (using conventional impression technique as reference), and passive fit of complete-arch implant supported restorations. The trial is an in vivo comparative study with direct 3D deviation analysis and evaluation.
- Conditions
- Complete Edentulism
- Being tested
- Digital impression using intraoral scanner, Digital impression using intraoral photogrammetry, Conventional impression
- Keywords
- digital impression, photogrammetry, Intraoral scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital impression using intraoral scannerProcedure or surgery
Digital impression of complete- arch edentulous patients using intraoral scanner
Digital impression using intraoral photogrammetryProcedure or surgery
Digital impression of complete-arch edentulous patients using intraoral photogrammetry
Conventional impressionProcedure or surgery
Conventional impression of complete-arch edentulous patients
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Scanner | Active comparator | Digital scanning of edentulous arches using intraoral scanner (Aoralscan Elite, Shining 3D) Receives: Procedure: Digital impression using intraoral scanner |
| Intraoral Photogrammetry | Active comparator | Digital scanning of edentulous arches using intraoral photogrammetry (Aoralscan Elite, Shining 3D) Receives: Procedure: Digital impression using intraoral photogrammetry |
| Conventional impression of edentulous arches | Active comparator | Conventional impression of complete- arch edentulous patients Receives: Procedure: Conventional impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital impressions of all the enrolled patients
STL files of digital impressions, intraoral scanning and photogrammetry , of all the enrolled patients.
Measured: After 3 months from implant placement for all the enrolled patients
Secondary outcomes (1)
Virtual analyses of implant positions
Three dimensional positional deviation for each abutment analog , as well as distance and angular deviations between all pairs of abutment analogs captured by intraoral scanning vs. intraoral photogrammetry digital impression - measured using metrology software (Geomagic Control X)
Measured: Within 3 months from digital impression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start25 Oct 2025
- Primary completion25 Jan 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a comparative in vivo clinical study in which each participant will undergo both digital impressions IOS and Intraoral Photogrammetry , using conventional impression technique as reference.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brunilda Koci, Assoc. Prof., Principal investigator, Aldent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211022
- Sponsor's protocol ID
- DIGIMP-FULLARCH-2025-01
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Complete Arch Digital Impressions Accuracy Using Photogrammetry and Intraoral Scanning
- ClinicalTrials.gov ID
- NCT07211022
- Acronym / sponsor ID
- DIGIMP-FULLARCH-2025-01
- Conditions
- Complete Edentulism
- Keywords
- digital impression, photogrammetry, Intraoral scanning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Aldent UniversityUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 7 Oct 2025 (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 clinical study evaluates and compares the accuracy (trueness and precision) of intraoral photogrammetry and intraoral scanning for complete-arch implant-supported prostheses in patients initially treated according to All-on-4 or All-on-6 concepts. Conventional impressions serve as the reference for assessing trueness. One patient initially treated with six implants lost one implant before impression acquisition and was therefore evaluated with five remaining implants.
Detailed description
The study aims to evaluate and compare two digital impression techniques, intraoral scanning and intraoral photogrammetry methods in terms of precision, accuracy (using conventional impression technique as reference), and passive fit of complete-arch implant supported restorations. The trial is an in vivo comparative study with direct 3D deviation analysis and evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a comparative in vivo clinical study in which each participant will undergo both digital impressions IOS and Intraoral Photogrammetry , using conventional impression technique as reference.
| Arm | Type | Receives |
|---|---|---|
| Intraoral Scanner | Active comparator | Procedure: Digital impression using intraoral scannerDigital scanning of edentulous arches using intraoral scanner (Aoralscan Elite, Shining 3D) |
| Intraoral Photogrammetry | Active comparator | Procedure: Digital impression using intraoral photogrammetryDigital scanning of edentulous arches using intraoral photogrammetry (Aoralscan Elite, Shining 3D) |
| Conventional impression of edentulous arches | Active comparator | Procedure: Conventional impressionConventional impression of complete- arch edentulous patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years
- Edentulous maxilla or mandible
- All-on-4 or All-on-6 implant supported restoration
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Severe systemic diseases (ASA III+)
- Bisphosphonate therapy
- Heavy bruxism
- Inability to attend follow-up
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 |
|---|---|---|
| Digital impression using intraoral scannerDigital impression of complete- arch edentulous patients using intraoral scanner | Procedure or surgery | Intraoral Scanner |
| Digital impression using intraoral photogrammetryDigital impression of complete-arch edentulous patients using intraoral photogrammetry | Procedure or surgery | Intraoral Photogrammetry |
| Conventional impressionConventional impression of complete-arch edentulous patients | Procedure or surgery | Conventional impression of edentulous arches |
Primary outcome
Digital impressions of all the enrolled patients
Time frame: After 3 months from implant placement for all the enrolled patients
STL files of digital impressions, intraoral scanning and photogrammetry , of all the enrolled patients.
1 secondary outcome
Virtual analyses of implant positions
Time frame: Within 3 months from digital impression
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 21 Oct 2026.
- Precision of complete-arch digital implant scans using photogrammetry and intra-oral scanning. An in vivo cross-over studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study Protocol
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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.
Brunilda Koci, Assoc. Prof. principal investigator
Aldent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital impression using intraoral scanner, Digital impression using intraoral photogrammetry and Conventional impression in people with Complete Edentulism, run by Aldent University at 1 site in Albania.
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 21 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 Albania. 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?
Digital impressions of all the enrolled patients (time frame: After 3 months from implant placement for all the enrolled patients). 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 21 Oct 2026.