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Clinical Trials/NCT06001515
NCT06001515RecruitingNot Applicable

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

Ain Shams University2 sites in 1 country12 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
12
Locations
2
Primary Endpoint
( Assessment of angular deviation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Triple blinded

Eligibility Criteria

Ages
50 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • The inclusion criteria will be completely edentulous patients, non-smokers, 50-70 years in age, have Good oral hygiene and motivation.

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.

Outcomes

Primary Outcomes

( Assessment of angular deviation

Time Frame: 1day

Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the angular deviation in degrees.

( Assessment of linear deviation

Time Frame: 1day

Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral coronal deviation in millimeters.

Secondary Outcomes

  • patient satisfaction(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dina Abdelmoez

assistant lecturer of oral and maxillofacial prosthodontics

Ain Shams University

Study Sites (2)

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