Evaluation of Bone Regenerated With Guided Bone Regenerat... | NCT06186232

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

NCT06186232

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Aug 21, 2024Actual

Enrollment

6Estimated

Phase

Not Applicable

Conditions

Horizontal Ridge Deficiency

Interventions

guided bone regeneration (GBR).

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Dec 15, 2023

First Submission Date that Met QC Criteria

Dec 28, 2023

First Posted Date

Dec 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2024

Last Update Posted Date

Aug 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rana Mohamed Sherif Abdel Mawgood, Evaluation Of Bone Regenerated After Guided Bone Regenration (GBR) using customized 3D printed Polymethylmethacrylate (PMMA) membrane in horizontally deficient maxillary aesthetic zone., Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient with horizontally deficient ridge in ethetic maxilary zone need (GBR) and implant placement	Other	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).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
guided bone regeneration (GBR).	Procedure	guided bone regeneration (GBR) using polymethylmethacrylate (PMMA) polymer as membrane.	patient with horizontally deficient ridge in ethetic maxilary zone need (GBR) and implant placement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Rana Sherif	Contact	01095306060		rana-mohamed@dentistry.cu.edu.eg
Eman Sayed	Contact			eman.shalaby@dentistry.cu.edu.eg

Name	Affiliation	Role
Hesham El Hawary	Professor of Oral and Maxillofacial surgery, Cairo university	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29264297	Background	Khojasteh A, Kheiri L, Motamedian SR, Khoshkam V. Guided Bone Regeneration for the Reconstruction of Alveolar Bone Defects. Ann Maxillofac Surg. 2017 Jul-Dec;7(2):263-277. doi: 10.4103/ams.ams_76_17.
25123759	Background	Benic GI, Hammerle CH. Horizontal bone augmentation by means of guided bone regeneration. Periodontol 2000. 2014 Oct;66(1):13-40. doi: 10.1111/prd.12039.