Evaluation of Bone Regenerated With Guided Bone Regeneration (GBR) Using Polymethylmethacrylate (PMMA) Membrane

August 20, 2024 updated by: Rana Mohamed Sherif Abdel Mawgood, Cairo University

Evaluation Of Bone Regenerated After Guided Bone Regenration (GBR) Using Customized 3D Printed Polymethylmethacrylate (PMMA) Membrane in Horizontally Deficient Maxillary Aesthetic Zone

To evaluate the quantity and quality of bone generated, radiographically and histomorphometrically, after guided bone regeneration (GBR) using a membrane of 3D printed custom made (PMMA) and subsequent stability of delayed implant placement.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Guided bone regeneration (GBR), is the most widely used technique to facilitate bone generation. It depends on using a biocompatible membrane that acts as physical barrier preventing the connective tissue from invading the bone defect.

To achieve maximum bone regeneration, GBR membrane should have several characteristics, including:

  • Biocompatibility.
  • Proper stiffness for space maintenance.
  • Prevent epithelial cell migration.
  • Appropriate resorption time after proper bone regeneration. Membranes used in guided bone regeneration (GBR) may have some limitations as the need of second surgery for removal of the membrane (in case of non-resorbable membranes as titanium mesh or expanded polytetrafluoroethylene (e-PTFE) membranes), lake of space maintenance (as collagen membranes) in addition to their high cost.

Thus, we aim to use a commercially available material as polymethyl methacrylate (PMMA) with (GBR) to facilitate bone generation as well as subsequent implant placement.

Recent forms of (PMMA), have been certified to be biocompatible and safe for skin and mucosal contact. PMMA is characterized by having high toughness which may provide a space maintenance when using as membrane in guided bone regeneration (GBR). The PMMA prosthesis can be pre-fabricated, which results in reduction of surgical time, easy technical handling and good esthetic results.

In addition, it has a relatively low cost when it is compared to other types of membranes used in guided bone regeneration (GBR).

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with edentulous area related to horizontally deficient aesthetic zone of maxilla.
  • Patients are physically healthy with no medical history of any systemic or local disease that would contraindicate ridge augmentation and/or implant surgery or complicate the healing process. (Severe liver or kidney disease, a history of head and neck radiotherapy, chemotherapy at the time of surgery, uncontrolled diabetes, active periodontal in the residual dentition, inflammatory or autoimmune disorders of the oral mucosa, poor oral hygiene, patient failure to cooperate, and any other disease condition contraindicating the oral surgery).
  • Non-smokers.
  • Free from temporomandibular joint disorders and abnormal oral habits such as bruxism.
  • The edentulous ridges were covered with optimal thickness of keratinized mucosa with no signs of inflammation, ulceration or scar tissue.
  • The occlusion shows sufficient inter-arch space for future prothesis.

Exclusion Criteria:

  • General contraindications to surgery.
  • Patients subjected to irradiation in the head and neck area less than 1 year before fixation.
  • Untreated periodontitis.
  • Poor oral hygiene.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Patients participating in other studies, if the present protocol could not be properly followed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient with horizontally deficient ridge in ethetic maxilary zone need (GBR) and implant placement
a group of patients with with horizontally deficient ridge in esthetic maxillary zone will undergo ridge augmentation with guided bone regeneration (GBR) technique using polymethylmethacrylate (PMMA) polymer as membrane.
Procedure: guided bone regeneration (GBR).
guided bone regeneration (GBR) using polymethylmethacrylate (PMMA) polymer as membrane.
Other Names:
  • implant installation 6 months after (GBR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of bone gain
Time Frame: 6 months postoperative
radiographic using cone beam computed tomography (CBCT)
6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of bone regenerated
Time Frame: 6 months after surgical procedure
bone core biopsy (histomorphometric analysis)
6 months after surgical procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative ridge width
Time Frame: 6 months postoperative
using bone caliper
6 months postoperative
initial implant stability
Time Frame: 6 months post operative
using manual ratchet
6 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Hesham El Hawary, Professor of Oral and Maxillofacial surgery, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMFS 3310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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