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

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.

Study Overview

• Status: Recruiting
• Conditions: Ridge Augmentation
• Intervention / Treatment: Procedure: sticky bone housed in PEEK Shell

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed MS Bahgat, BDS; Phone Number: 002 01007419224; Email: mohamed.samy@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Recruiting
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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.
• Patients participating in other studies, if the present protocol could not be properly followed.
• Referred only for implant placement or unable to attend a 5-year follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Augmented group; Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement	Procedure: sticky bone housed in PEEK Shell; Patient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically successful osseointegrated implant	measuring primary stability immediately after implant placement and in the second surgery using Ostell device	At the day of the surgery and 6 months after first surgery
Accuracy of Plan Transfer	superimposing the preoperative CBCT and the immediately postoperative CBCT to measure the accuracy of the procedure compared to the plan done	1-3 days postoperatively
Bone Quality	Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone quality in Hounsfield units	0 before surgery, T1 immediately after surgery and T2 after 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2022
• Primary Completion (Anticipated): November 25, 2023
• Study Completion (Anticipated): May 25, 2024

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 16722

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No