Clinical trial NCT06001515: Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses
Official title: Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Computer-Assisted Surgery
Keywords: guided implant placement- face scanning - edentulous maxilla
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one experimental group and one active comparator group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ( Assessment of linear deviation
timeFrame: 1day
measure: ( Assessment of linear deviation
timeFrame: 1day
measure: ( Assessment of angular deviation
timeFrame: 1day
Secondary outcomes:
measure: patient satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Noha H Nawar, BDS MSc MD
role: STUDY_DIRECTOR
References: