- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07643441
Accuracy of Complete-Arch Implant Photogrammetry
Accuracy of Complete-arch Implant Scans Obtained Using Intraoral Photogrammetry and a Mobile-phone Based Photogrammetry.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Accurate recording of implant positions is essential for the passive fit and long-term success of complete-arch implant-supported prostheses. Photogrammetry-based technologies have emerged as promising alternatives to conventional digital impression techniques for capturing implant positions with high accuracy. While intraoral photogrammetry systems have demonstrated favorable results, the clinical performance of recently introduced mobile-phone-based photogrammetry systems remains insufficiently investigated.
This prospective comparative clinical study aims to evaluate the accuracy and chairside time of complete-arch implant scans obtained using an intraoral photogrammetry system and a mobile-phone-based photogrammetry system in edentulous patients restored with complete-arch implant-supported prostheses. Each participant will undergo implant scanning using both systems according to the manufacturers' recommendations. The resulting digital datasets will be compared with a reference dataset to determine scan accuracy.
The primary outcome measures will be linear and angular discrepancies between the implant positions captured by each photogrammetry system and the reference dataset. Secondary outcome measures will include the chairside time required for scan acquisition. Statistical analyses will be performed to compare the accuracy and efficiency of the evaluated systems.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohammed El-Sawy, PhD
- Phone Number: 00201061314522
- Email: mohamed.elsawy@dent.menofia.edu.eg
Study Locations
-
-
Menoufia
-
Shibīn al Kawm, Menoufia, Egypt, 2266166
- Recruiting
- Mohammed El-Sawy
-
Contact:
- Mohammed Elsawy
- Email: mohamed.elsawy@dent.menofia.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Completely edentulous patients rehabilitated with implant-supported complete-arch prostheses.
- Presence of at least four osseointegrated implants in the edentulous arch.
- Patients able to undergo digital implant scanning procedures.
- Patients willing to participate and provide written informed consent.
Exclusion Criteria:
- Patients with unstable or failed implants.
- Presence of peri-implant disease, active oral infection, or significant soft-tissue inflammation around the implants.
- Inadequate access for placement of photogrammetry scan bodies or markers.
- Patients with conditions that prevent proper scanning procedures (e.g., inability to maintain mouth opening or remain still during data acquisition).
- Patients requiring immediate implant placement or immediate loading protocols.
- Patients unwilling or unable to provide informed consent.
- Incomplete clinical records or inability to complete all study procedures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intraoral Photogrammetry (IPG)
Participants will undergo complete-arch implant scanning using an intraoral photogrammetry system (IPF Elite, Shining 3D).
Implant positions will be digitally recorded according to the manufacturer's instructions.
Linear and angular discrepancies relative to the reference dataset, as well as chairside scanning time, will be evaluated.
|
A photogrammetry-based digital impression system used to capture the three-dimensional positions of implants in complete-arch rehabilitations.
The system records implant locations through specialized scan bodies and generates a digital dataset for subsequent accuracy analysis.
Other Names:
|
|
Mobile-Phone-Based Photogrammetry
Participants will undergo complete-arch implant scanning using a mobile-phone-based photogrammetry system (T-Marker).
Implant positions will be digitally recorded according to the manufacturer's instructions.
Linear and angular discrepancies relative to the reference dataset, as well as chairside scanning time, will be evaluated.
|
A smartphone-assisted photogrammetry system used to capture the three-dimensional positions of implants in complete-arch rehabilitations.
The system acquires photographic data through coded markers and generates a digital dataset for subsequent accuracy analysis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Linear Discrepancy of Complete-Arch Implant Scans
Time Frame: Immediately after scan acquisition and digital analysis (same study visit).
|
Assessment of the linear deviation (μm) between implant positions captured using intraoral photogrammetry and mobile-phone-based photogrammetry systems and those recorded in the reference dataset.
Lower values indicate greater accuracy.
|
Immediately after scan acquisition and digital analysis (same study visit).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohammed A. El-Sawy, PhD, Menoufia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADMNF-000026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Edentulous Jaw
-
October 6 UniversityNot yet recruitingPartially Edentulous Jaw
-
Mansoura UniversityActive, not recruiting
-
Dentsply Sirona Implants and ConsumablesNot yet recruitingEdentulous Jaw | Edentulous MouthUnited States
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
University of Alabama at BirminghamZimmer DentalCompleted
-
Cairo UniversityCompletedEdentulous Alveolar Ridge Atrophy | ATROPHYC EDENTULOUS JAW | Edentulous Maxilla | Edentulous Alveolar Ridge In MandibleEgypt
-
University of IowaCompletedEdentulous Jaw | Edentulous MouthUnited States
-
Concordia Dent SrlITI International Team for Implantology, SwitzerlandCompletedMANDIBLE | ATROPHYC EDENTULOUS JAWRomania
-
Lithuanian University of Health SciencesHacettepe University; University of Michigan; University of Messina; Universidad...UnknownPartially Edentulous JawLithuania
-
Shanghai Ninth People's Hospital Affiliated to...Enrolling by invitationEdentulous JawChina
Clinical Trials on Intraoral Photogrammetry (IPG)
-
Abdelrahman Khalaf EldabeActive, not recruitingEdentulism | Implant-supported Full-arch Prosthesis | Digital Impression Accuracy | Photogrammetry in DentistryEgypt
-
Aldent UniversityCompletedComplete EdentulismAlbania
-
Ain Shams UniversityActive, not recruiting
-
X-Nav Technologies, LLCCompletedDoctor Efficiency | Dental Prosthesis FitUnited States
-
Guy's and St Thomas' NHS Foundation TrustMedtronicNot yet recruitingInfections | Chronic Pain | Neuropathic Pain | Device Related Sepsis
-
William NegreirosITI International Team for Implantology, SwitzerlandCompletedPrecision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus PhotogrammetryEdentulous JawUnited States
-
Pablo López PaisRecruitingFailed Back Surgery Syndrome | Spinal Cord StimulationSpain
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
Dennis Turner, M.D.National Institute of Neurological Disorders and Stroke (NINDS); National Institutes...Completed