3D Integration of Facial , Intraoral Scanning and CBCT on Patient Satisfaction and Occlusion of Temporary, Permanent Implant Supported Prosthesis

Effect of 3D Integration of Facial Scanning, Intraoral Scanning and CBCT on Patient Satisfaction and Occlusion of Temporary and Permanent Full Arch Implant Supported Prosthesis

This study will aim to evaluate the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.

Study Overview

• Status: Active, not recruiting
• Conditions: Patient Satisfaction; Occlusal Analysis
• Intervention / Treatment: Device: occluscence; Other: patient satisfaction

Detailed Description

Aim: evaluating the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.

Methods:1. Four radio opaque markers on patient's face will be placed. The first facial scan will be done (FS1) using a facial scanner (Bellus3D mobile application) while the patient is smiling.

2.A proper size of triple tray will be selected and adjusted if needed, and the impression material will be kept to the minimum required to avoid any overextension that can cause forced soft tissue displacement. The handle will be removed and 3 markers will be placed on the front of the triple tray.

3- The tray will be filled with heavy body vinylpolysiloxane (VPS) material and inserted in patient's mouth. The patient will be instructed to close in habitual occlusion and the second facial scan (FS2) will be taken with the head in the same position.

4. Both facial scans will be imported to a dental software design program as STL1 and STL2 files, respectively. A CBCT will be taken while the markers are still in place. Through the face scans and CBCT scan, make sure the patient is in a natural head position where reference lines (Frankfurt plane and occlusal plane) are confirmed to be parallel to the floor. The patient will be instructed to stay still.

5. The maxillary and mandibular intraoral scans will be taken with jaw relation record (STL3) using an intraoral scanner and scan the triple tray on both sides and external borders with markers in place using the Bio copy tool in Prime scan (STL4).

6. All scans will be exported to the design software. and use the design module of CAD software to superimpose the facial scans (STL1 and STL2) by using markers as reference points 7.The intraoral scans will be integrated to facial scans by using the inter arch impression STL4 (Scan of triple tray or Bio copy) as a merging tool. Complete the facially generated diagnostic wax up (STL5).

8. The completed maxillary diagnostic wax up (STL5) will be exported, pre op intraoral scans (STL3) and will be imported to implant planning software using STL markers to merge STL files correctly. the STL files with CBCT will be merged, and the interim restoration will be designed in the software program and it will be 3D printed.

9.the interim restoration will be inserted and the patient satisfaction and occlusion will be evaluated.

10. The patient will receive postoperative instructions until the definitive prostheses will be fabricated.

11.After insertion of the permanent restoration the patient satisfaction and occlusion will be evaluated.

Evaluation:• Occlusal analysis will be evaluated by occluo-scence (measuring the balance of occlusal contact forces, the sequence, strength, and density of the occlusal contacts The patient's recorded occlusal information will be transmitted and displayed on the app.

• patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent).

Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Faculty of Dentistry Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy individuals with the completely edentulous maxilla and mandible rehabilitated by six implants.

Exclusion Criteria:

• individuals with uncontrolled systemic diseases that affect the success of implant survival rate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Temporary full arch implant supported prosthesis.; full arch temporary implant supported prosthesis will be fabricated for the first group using PMMA material	Device: occluscence; The OccluSense handheld is a battery powered device which uses your local wireless network to transmit the recorded data to the OccluSense-iPad-App. The inductive charger provides wireless power transfer. Fully charged batteries allow up to 4 hours usage of the device.; Other: patient satisfaction; • patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent). Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?
Active Comparator: permanent full arch implant supported prosthesis.; Permanent full arch implant supported prosthesis will be fabricated for the second group from zirconia	Device: occluscence; The OccluSense handheld is a battery powered device which uses your local wireless network to transmit the recorded data to the OccluSense-iPad-App. The inductive charger provides wireless power transfer. Fully charged batteries allow up to 4 hours usage of the device.; Other: patient satisfaction; • patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent). Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occlusion of temporary and permanent full arch implant supported prosthesis constructed by digital workflow	"through study completion, an average of 1 year"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction of temporary and permanent full arch implant supported prosthesis constructed by digital workflow using (vas score)	• patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent). Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?	"through study completion, an average of 1 year"

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mostafa Abdo El Syad, Professor, Faculty of Dentistry Mansoura University

Publications and helpful links

General Publications

• Kuhlman DC, Almuzian M, Coppini C, Alzoubi EE. Accuracy (trueness and precision) of four tablet-based applications for three-dimensional facial scanning: An in-vitro study. J Dent. 2023 Aug;135:104533. doi: 10.1016/j.jdent.2023.104533. Epub 2023 May 4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A04012023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes