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

October 21, 2023 updated by: Dina Abdelmoez, Ain Shams University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed Mostafa, BDS MSc MD

Study Locations

  • Egypt
      • Cairo, Egypt, 11361
        • Recruiting
        • Faculty of Dentistry Ain Shams university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Dual scan protocol
one CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone
Experimental: 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.
Device: triple scan protocol
3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
( 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.
1day
( Assessment of linear deviation
Time Frame: 1day
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral apical deviation in millimeter.
1day
( 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.
1day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 1 day
Accurate details recorded by using a 5 points likert scale for measuring the patient satisfaction by filling specific questionnaire: Oral Health Impact Profile 14 questions ( OHIP-14) and taking the answer of each question on a 5 point likert scale with 0 for the worst score and 5 for the best one
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Noha H Nawar, BDS MSc MD, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-RecID012328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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