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Clinical Trials/NCT05624697
NCT05624697
Recruiting
N/A

Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series

Cairo University1 site in 1 country10 target enrollmentNovember 25, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ridge Augmentation
Sponsor
Cairo University
Enrollment
10
Locations
1
Primary Endpoint
Bone gain
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment.

Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately.

Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.

Registry
clinicaltrials.gov
Start Date
November 25, 2022
End Date
May 25, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Mahmoud Samy Bahgat

Principal Investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample.
  • Patients who already gave their consent for this trial.
  • Males and females both will be included.

Exclusion Criteria

  • Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study.
  • Subjected to irradiation in the head and neck region within the last year
  • Patients allergic to drugs used in the study like ( Articaine, Lidocaine,
  • Patients having a history of a major medical condition (ASA 3,4)
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.

Outcomes

Primary Outcomes

Bone gain

Time Frame: T0 before surgery, T1 immediately after surgery and T2 after 6 months

Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm

Secondary Outcomes

  • Bone Quality(0 before surgery, T1 immediately after surgery and T2 after 6 months)
  • Accuracy of Plan Transfer(1-3 days postoperatively)
  • Clinically successful osseointegrated implant(At the day of the surgery and 6 months after first surgery)

Study Sites (1)

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