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

NCT06001515 | Unknown

• 1 other identifier: FDASU-RecID012328
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Computer-Assisted Surgery

Keywords

guided implant placement- face scanning - edentulous maxilla

Outcome Measures

Primary Outcomes (3)

• ( Assessment of linear deviation

  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

  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

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

  1day

Secondary Outcomes (1)

• patient satisfaction

  1 day

Study Arms (2)

Dual scan protocol

ACTIVE COMPARATOR

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

Dual scan protocol +3D facial scan record

EXPERIMENTAL

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

Interventions

Dual scan protocol DEVICE

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

Dual scan protocol

triple scan protocol DEVICE

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

Dual scan protocol +3D facial scan record

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

RECRUITING

Study Officials

• Noha H Nawar, BDS MSc MD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Dina Abd Elmoez, BDS MSc

CONTACT

01030762236; Dodo1992am@gmail.com

Ahmed Mostafa, BDS MSc MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of oral and maxillofacial prosthodontics

Model Details: one experimental group and one active comparator group

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-10

Locations

EG (1)