Comparing Scanning Accuracy of Full-Arch Maxillary Implants: Extraoral vs. Intraoral Techniques

NCT ID: NCT06669065

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-12-25

Brief Summary

Data acquisition from the patients:

After 4 months of implant placement, three impressions/scans will be made for each patient as follows:

Data 1: conventional impression using open tray transfer copings and silicon impression material. After cast verification, the scan bodies will be connected to the analogues on the master cast, which will be scanned using a laboratory scanner. The STL file will be used as a reference scan.

Data 2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison.

Data 3: the scan bodies will be splinted using dental floss after being connected to the implants intraorally and then a scan will be made using the intraoral scanner. The STL file will be stored for comparison.

• Data alignment and accuracy measurements: The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts.

• Statistical analysis: Data will be collected, analysed, and then tabulated.

Detailed Description

Data acquisition from the patients:

After the osseointegration period of the dental implants, three impressions/scans will be made for each patient as follows:

1. Data #1: A conventional impression using open tray transfer copings will be connected to the dental implants intraorally and splinted together using dental floss and a duralay resin pattern to ensure complete fixation and immobility. Then, a custom acrylic resin tray with an open window and silicon impression material will be used for the final impression making. a master cast will be poured, and the transfer copings will be reconnected onto the implant analogues inside the cast to replicate implant positions intraorally. the transfer copings/impression posts will be connected with duralay resin pattern to form a verification jig assembly. The verification jig assembly will be connected to the implants inside the patient's mouth to check passivity, in case of improper passivity, the jig will be sectioned at areas between the implants and then reconnected with duraly and an impression will be repeated, if passivity is ensured, the verification jig assembly will be reconnected to the master cast that will be then deemed as a verified master cast. The next step after master cast verification is the connection of the scan bodies to the implant analogues then scanning it with a laboratory scanner to gain an STL file of the (control) group or the (reference) group of the research.

2. Data #2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison. (comparator 1)

3. Data #3: scan bodies will be splinted together using dental floss and composite resin will be added to the floss at areas found between the scan bodies to add some irregularities, then a scan will be made using the intraoral scanner. The STL file will be stored for comparison. (comparator 2)

• Data alignment and accuracy measurements:

The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts.

• Statistical analysis:
• Handling of numerical/quantitative variables:

Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests. Data will be presented as mean & standard deviation. If data will be normally distributed comparison between 2 different groups will be performed by using Independent t-test, a comparison between 2 related groups will be performed by using a Paired t-test, while a comparison between more than 2 groups will be performed by using A Way ANOVA test followed by Tukey's Post Hoc test for multiple comparisons.

If data will be non-parametric data comparison between 2 different groups will be performed by using the Mann-Whitney test, a comparison between 2 related groups will be performed by using the Wilcoxon Signed Rank test, while a comparison between more than 2 groups will be performed by using Kruskal-Wallis test.

• Handling of categorial/qualitative variables: Data will be presented as frequency and percentages. All comparisons will be performed by using the Chi-square test.

Statistical analysis:

Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.

Conditions

Edentulous Maxilla

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

patients rehabilitated with dental implants in upper edentulous jaws

patients rehabilitated with dental implants in upper edentulous jaws, then different data acquisition techniques will be applied to the patients using conventional impressions versus intra-oral scanning methods

Group Type: EXPERIMENTAL

extraoral versus intraoral scanning techniques

Intervention Type: DEVICE

different data acquisition techniques for full-arch dental implants

Interventions

extraoral versus intraoral scanning techniques

different data acquisition techniques for full-arch dental implants

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Completely edentulous patients who had been wearing complete dentures and received 4 implants in the upper jaw.

2. Patients with no systemic diseases affecting bone remodelling and osseointegration.

3. Ridges showing well-keratinized mucosa.

Exclusion Criteria

1. Smokers.

2. Non-compliant patients.

3. Patients with systemic diseases that may affect bone remodelling and osseointegration.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Misr University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

HEBA ELSARRIF

Principal Investigator, Lecturer of Removable Prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HEBA ELSARRIF

Role: PRINCIPAL_INVESTIGATOR

Misr University for Science and Technology

Locations

Misr University for Science and Technology

Giza, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

2024/0016

Identifier Type: -

Identifier Source: org_study_id