Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.

3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study

Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .

Study Overview

• Status: Completed
• Conditions: Ridge Deficiency
• Intervention / Treatment: Procedure: Patient specific PEEK sheets; Procedure: Autogenous bone shell

Detailed Description

A- Intervention Group (Patient specific PEEK sheets)

• Preoperative Computed tomography will be done to the patients.
• Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
• Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
• After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
• Wounds closure will be done.
• CT scan will be done postoperative.
• After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.

B- Control Group (Autogenous bone shell technique)

• Preoperative Computed tomography will be done to the patients
• Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
• The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
• The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
• Wounds closure will be done.
• CT scan will be done.
• After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ola A El-Morsy, B.D.S; Phone Number: 002-01141234877; Email: dr.ola.elmorsy@gmail.com
• Study Contact Backup: Name: Mohamed M Shaker, PhD; Phone Number: 002-01001505798; Email: mouniroma@hotmail.com

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Faculty of Oral and Dental Medicine - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with deficient alveolar bone in the anterior maxilla.
• Patient seeking fixed prosthesis at the anterior maxillary region.
• Highly motivated patients.
• Good oral hygiene.
• Patients willing for the surgical procedure and follow-up, with an informed consent.
• Bounded anterior maxilla cases.

Exclusion Criteria:

• Medically compromised patients.
• Uncooperative patients.
• Poor oral hygiene.
• Periodontal diseases.
• No history of any grafting procedure at the designated edentulous ridge.Criteria
• Patients with any diseases that compromise bone or soft tissue healing.
• Patients with no local pathosis that interfere with the bone healing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient specific PEEK sheets; Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge .	Procedure: Patient specific PEEK sheets; Computer aided sheet design
Active Comparator: Autogenous bone shell technique; Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge .	Procedure: Autogenous bone shell; autogenous retromolar/chin bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone gain	Bone gain will be evaluated using the Computed tomography , measuring unit (mm)	4-6 months post-operative
Bone quality	Histological analysis of bone core biopsy , measuring unit Osteon number	4-6 months post-operative
Soft tissue reaction	Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm)	4-6 months postoperative
Intraoperative time	Using stop watch to measure the operative time	Intraoperative

Collaborators and Investigators

• Sponsor: Ola Alaa El-Din Abd El-Monem Mohamed
• Collaborators: Cairo University
• Investigators: Study Director: Ahmed A Brakart, PhD, Cairo University; Study Director: Mohamed M Shaker, PhD, Cairo University

Publications and helpful links

General Publications

• Mounir M, Morsy OAE, Amer H, Mounir S, Gibaly A. Assessment of bone quality using buccal and palatal autogenous cortical shells harvested from two different mandibular donor sites for maxillary alveolar ridge augmentation: a histomorphometric randomized clinical trial. Oral Maxillofac Surg. 2021 Jun;25(2):263-269. doi: 10.1007/s10006-020-00924-w. Epub 2020 Nov 24.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PEEK; Anterior maxillary region; Patient specific; Autogenous bone shell; Ridge augmentation
• Other Study ID Numbers: CEBD-CU-2018-07-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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