Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Accuracy

Intervention / Treatment
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* Other: full arch implant supported screw retained restoration with conventional impression technique
* Other: full arch implant supported screw retained restoration with conventional digital technique


Participation Criteria
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Eligibility Criteria
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Inclusion 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 as verified by tentative jaw relation. Sufficient residual alveolar ridge. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional (Open tray impression technique)<br>After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level. | Other: full arch implant supported screw retained restoration with conventional impression technique<br>* surgical procedures: Implant installation Prosthetic procedures: Conventional impression fabrication of full arch implant supported screw-retained restoration evaluation: Accuracy, Passive fit<br>|
| Active Comparator: Digital impression<br>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. | Other: full arch implant supported screw retained restoration with conventional digital technique<br>* surgical procedures: Implant installation Prosthetic procedures: Digital impression fabrication of full arch implant-supported screw-retained restoration evaluation: Accuracy, Passive fit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive fit | Passive fit of framework will be evaluated at time of insertion (Sheffield test) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accuracy, implant level impression, abutment level impression