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

NCT05624697 | Unknown

• 1 other identifier: 16722
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

• Bone gain

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

  T0 before surgery, T1 immediately after surgery and T2 after 6 months

Secondary Outcomes (3)

• Clinically successful osseointegrated implant

  At the day of the surgery and 6 months after first surgery

• Accuracy of Plan Transfer

  1-3 days postoperatively

• Bone Quality

  0 before surgery, T1 immediately after surgery and T2 after 6 months

Study Arms (1)

Augmented group

OTHER

Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement

Procedure: sticky bone housed in PEEK Shell

Interventions

sticky bone housed in PEEK Shell PROCEDURE

Patient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla

Augmented group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Active infection or severe inflammation in the area intended for implant placement.
• Unable to open mouth sufficiently to accommodate the surgical tooling.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11553, Egypt

RECRUITING

Central Study Contacts

Mohamed MS Bahgat, BDS

CONTACT

01007419224; mohamed.samy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 22, 2022
• Study Start: November 25, 2022
• Primary Completion: November 25, 2023
• Study Completion: May 25, 2024
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

EG (1)