Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses

NCT ID: NCT06001515

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-09-30

Brief Summary

The study will compare the accuracy of surgical guides fabricated by two different scanning protocols; facially driven scanning versus dual scanning protocol regarding the deviation of implant placement.

Detailed Description

Twelve completely edentulous patients will be selected for full arch maxillary guided implants placement with immediately loaded restoration. The patients will make a complete oral and radiographic examination before inclusion in this study. All patients will receive maxillary and mandibular complete dentures that will be made in a conventional way. The patients will be randomly divided into two equal groups; group (I) and group (II). In both groups two CBCT scans will be made. A CBCT scan will be made for each patient while wearing the radiographic stent and another CBCT scan will be made for the radiographic stent alone. However, for patients in group II a face scan will be added to previous scans. For each patient in group I, the DICOM files will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH), fusion of the scan prosthesis via the markers is accomplished and the ideal surgical site and optimal implant dimensions will be selected. All the surgical guides will be planned to be totally limiting in this study. The immediate provisional restoration will be planned on the software according to the previously planned implants sites. The surgical guide will be 3D printed. The approved tooth arrangement will be subsequently sent as an STL file to a milling machine. For each patient in group II, the DICOM files and the STL files obtained from the face scans will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH). The facial scan will be used to define the interpupillary and midsagittal planes and to examine the tooth form and buccal corridor width with regard to the patient's smile line. Both files data will be superimposed and the planning for the implants sites, surgical guide and immediate restoration will be done as in group I. After implant insertion, CBCT scan will be made for each patient while wearing the scan appliance. Superimposition of CBCT scans pre and post implant insertion and restoration will be made. Deviations between planned and placed implant will be measured in the lateral apical, lateral coronal and angular aspects. Also, the patient satisfaction will be measured on a likert scale.

Conditions

Computer-Assisted Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dual scan protocol

Two CBCT scans will be made.One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone.

Group Type: ACTIVE_COMPARATOR

Dual scan protocol

Intervention Type: DEVICE

one CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone

Dual scan protocol +3D facial scan record

3D face scan record will be made plus Two CBCT scans. One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone.

Group Type: EXPERIMENTAL

triple scan protocol

Intervention Type: DEVICE

3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol

Interventions

Dual scan protocol

one CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone

Intervention Type: DEVICE

triple scan protocol

3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

• The excluded patients will include patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dina Abdelmoez

assistant lecturer of oral and maxillofacial prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha H Nawar, BDS MSc MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina Abd Elmoez, BDS MSc

Role: CONTACT

Dodo1992am@gmail.com

01030762236

Ahmed Mostafa, BDS MSc MD

Role: CONTACT

Facility Contacts

Ahmed Abdelfattah, BSc, MSc, MD

Role: primary

ahmedmostafa@dent.asu.edu.eg

01111191337

Other Identifiers

FDASU-RecID012328

Identifier Type: -

Identifier Source: org_study_id