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

NCT ID: NCT05624697

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2024-05-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Augmented group

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

Group Type: OTHER

sticky bone housed in PEEK Shell

Intervention Type: PROCEDURE

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

Interventions

sticky bone housed in PEEK Shell

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

Intervention Type: PROCEDURE

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mahmoud Samy Bahgat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed MS Bahgat, BDS

Role: CONTACT

mohamed.samy@dentistry.cu.edu.eg

01007419224 ext. 002

Other Identifiers

16722

Identifier Type: -

Identifier Source: org_study_id