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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06186232
Enrollment
10
Registered
2023-12-29
Start date
2025-01-01
Completion date
2026-05-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horizontal Ridge Deficiency

Keywords

polymethylmethacrylate

Brief summary

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.

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).

Interventions

PROCEDUREguided bone regeneration (GBR).

guided bone regeneration (GBR) using polymethylmethacrylate (PMMA) polymer as membrane.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
amount of bone gain6 months postoperativeradiographic using cone beam computed tomography (CBCT)

Secondary

MeasureTime frameDescription
quality of bone regenerated6 months after surgical procedurebone core biopsy (histomorphometric analysis): Because the augmentation wasn't maintained in most cases, the resulting specimens varied too much to support a standardized quantitative histomorphometric protocol. Consequently, descriptive histopathology was performed instead.

Countries

Egypt

Contacts

STUDY_DIRECTORHesham El Hawary

Professor of Oral and Maxillofacial surgery, Cairo university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026