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Clinical Trials/NCT06571968
NCT06571968
Completed
Not Applicable

Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible by Using Fully Versus Semi Guided Prototyped Surgical Stent

Mansoura University1 site in 1 country36 target enrollmentMay 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant Placement
Sponsor
Mansoura University
Enrollment
36
Locations
1
Primary Endpoint
Radio graphic evaluation (Angular deviation)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.

Detailed Description

Objectives: Current study aimed to assess the accuracy of fully- guided implant placement in completely lower edentulous patients compared to the semi-guided protocol. Materials and Methods: Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants. Measurements and analysis of results were performed by means of a software tool used during virtual planning (P3Dental; Protótipos).

Registry
clinicaltrials.gov
Start Date
May 14, 2023
End Date
February 2, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
  • Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
  • Long term immunosuppress and corticosteroid drug therapy.
  • Patient with abnormal habits as clenching and bruxism.
  • Smoking patient.
  • Patient with problems in TMJ

Outcomes

Primary Outcomes

Radio graphic evaluation (Angular deviation)

Time Frame: one year

For both groups, postoperative CBCT scan was performed after implant placement. The same parameters of preoperative CBCT were followed according to the patient's position, image acquisition, and use of the same apparatus. This scan was performed with the same dental prosthesis as that used for the initial preoperative CBCT scanning, equipped with the gutta percha references, for superimposition of the images. The previously fabricated occlusal registration was used to align the prosthesis. Both CBCT scans were superimposed, and the software compared preoperative horizontal (Mesiodistal and buccolingual), vertical and angular virtual measurements of planned implants with real measurements of the placed implants.

Secondary Outcomes

  • Radio graphic evaluation (linear deviation)(one year)

Study Sites (1)

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