Clinical trial NCT03607006: Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Deficiency
Keywords: Anterior maxillary region
Patient specific
Autogenous bone shell
PEEK
Ridge augmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-07-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * A randomized clinical trial.
* Parallel group study.
* A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .
* Equal randomization : participants with equal probabilities for intervention.
* Positive controlled : Both groups receiving treatment.
Primary purpose: TREATMENT

Brief 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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 8 months
Secondary outcomes:
measure: Bone gain
timeFrame: 4-6 months post-operative
measure: Bone quality
timeFrame: 4-6 months post-operative
measure: Soft tissue reaction
timeFrame: 4-6 months postoperative
measure: Intraoperative time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Oral and Dental Medicine - Cairo University
Study officials:
affiliation: Cairo University
name: Ahmed A Brakart, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed M Shaker, PhD
role: STUDY_DIRECTOR
References:
citation: 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.