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

Ridge Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607006
• Other study ID #: CEBD-CU-2018-07-16
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ridge Deficiency

Intervention

Procedure:
• Patient specific PEEK sheets
Computer aided sheet design
• Autogenous bone shell
autogenous retromolar/chin bone graft

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine - Cairo University	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Ola Alaa El-Din Abd El-Monem Mohamed	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)	8 months
Secondary	Bone gain	Bone gain will be evaluated using the Computed tomography , measuring unit (mm)	4-6 months post-operative
Secondary	Bone quality	Histological analysis of bone core biopsy , measuring unit Osteon number	4-6 months post-operative
Secondary	Soft tissue reaction	Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm)	4-6 months postoperative
Secondary	Intraoperative time	Using stop watch to measure the operative time	Intraoperative