Skip to main content
OpenTrials
Completed

NCT Number: NCT03607006

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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine - Cairo University

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient specific PEEK sheets

Procedure

Computer aided sheet design

Autogenous bone shell

Procedure

autogenous retromolar/chin bone graft

Primary outcomes

  1. Patient satisfaction

    Time frame: 8 months

    Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)

Secondary outcomes

  1. Bone gain

    Time frame: 4-6 months post-operative

    Bone gain will be evaluated using the Computed tomography , measuring unit (mm)

  2. Bone quality

    Time frame: 4-6 months post-operative

    Histological analysis of bone core biopsy , measuring unit Osteon number

  3. Soft tissue reaction

    Time frame: 4-6 months postoperative

    Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm)

  4. Intraoperative time

    Time frame: Intraoperative

    Using stop watch to measure the operative time

Sponsors and collaborators

Lead sponsor

Ola Alaa El-Din Abd El-Monem Mohamed

Other

Collaborators

  • Cairo University

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.