Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
ConditionEdentulism Complete
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorMenoufia University
About this trial
This randomized crossover clinical study will evaluate and compare the accuracy and chairside time of two non-calibrated splinting systems, IoConnect and Scan Pro, for obtaining complete-arch implant digital scans. The study will include completely edentulous patients with four well-integrated implants connected to multiunit abutments.
Each participant will undergo complete-arch implant scanning using both systems, with the order of the scanning protocols determined by a computer-generated randomization sequence. The digital scans obtained with each system will be compared with a verified conventional implant impression used to establish a reference model.
The primary evaluation will focus on the accuracy of the implant scans by assessing linear and angular discrepancies between each experimental scan and the reference model. Chairside time required for the scanning procedures will also be recorded. The study will determine whether differences exist between the two non-calibrated splinting systems in terms of complete-arch implant scan accuracy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Completely edentulous maxilla or mandible.
Four clinically stable and osseointegrated implants restored with multiunit abutments.
Patients with a screw-retained interim prosthesis or patients scheduled to receive a definitive complete-arch implant-supported prosthesis.
Disqualifiers
Fewer or more than four implants in the evaluated arch.
Failed or clinically unstable implants.
Active peri-implant infection or suppuration.
Limited mouth opening that prevents completion of the intraoral scanning procedures.
Trial design
Design model
Crossover
Treatments tested in this trial
Scan Pro
DeviceComplete-arch implant scanning using the Scan Pro noncalibrated splinting system and an intraoral scanner. The scan bodies are connected using adjustable arms to provide optical splinting, and the resulting digital impression is exported as an STL file for accuracy assessment.
IoConnect
DeviceComplete-arch implant scanning using the IoConnect noncalibrated splinting system and an intraoral scanner. The workflow includes acquisition of peri-implant soft-tissue anatomy followed by acquisition of the horizontal optical markers. The datasets are merged using the dedicated software to generate the final digital implant impression.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Scan Pro → IoConnectExperimental treatment 2 interventions
Group B: IoConnect → Scan ProExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Linear trueness of complete-arch implant scans
Linear trueness will be assessed as the three-dimensional Euclidean deviation between corresponding implant positions in the reference digital dataset and each experimental scan dataset. For each participant, the mean linear deviation across the four implants will be calculated for each scanning protocol. Lower deviation values indicate greater trueness.
Time frame
Immediately after completion of each scanning protocolSecondary outcomes
1
Angular trueness of complete-arch implant scans
Angular trueness will be assessed as the angular deviation between the corresponding longitudinal axes of the implants in the reference digital dataset and each experimental scan dataset. For each participant, the mean angular deviation across the four implants will be calculated for each scanning protocol. Lower angular deviation values indicate greater trueness.
Time frame
Immediately after completion of each scanning protocolSponsors and contacts
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Menoufia University
Lead sponsor
Mansoura University
Collaborator
Source ClinicalTrials.gov