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

Ola Alaa El-Din Abd El-Monem Mohamed

Status: Completed

Conditions: Ridge Deficiency

Treatments: Procedure: Patient specific PEEK sheets; Procedure: Autogenous bone shell

Study type: Interventional

Funder types: Other

Identifiers

NCT03607006

CEBD-CU-2018-07-16

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Patient specific PEEK sheets

Experimental group

Description:

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 .

Treatment:

Procedure: Patient specific PEEK sheets

Autogenous bone shell technique

Active Comparator group

Description:

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 .

Treatment:

Procedure: Autogenous bone shell