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

NCT ID: NCT06186232

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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).

Conditions

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Horizontal Ridge Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

guided bone regeneration (GBR).

Intervention Type PROCEDURE

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

Interventions

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guided bone regeneration (GBR).

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

Intervention Type PROCEDURE

Other Intervention Names

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implant installation 6 months after (GBR)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hesham El Hawary

Role: STUDY_DIRECTOR

Professor of Oral and Maxillofacial surgery, Cairo university

Central Contacts

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Rana Sherif

Role: CONTACT

01095306060

Eman Sayed

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 29264297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25123759 (View on PubMed)

Elgali I, Omar O, Dahlin C, Thomsen P. Guided bone regeneration: materials and biological mechanisms revisited. Eur J Oral Sci. 2017 Oct;125(5):315-337. doi: 10.1111/eos.12364. Epub 2017 Aug 19.

Reference Type BACKGROUND
PMID: 28833567 (View on PubMed)

Lee SW, Kim SG. Membranes for the Guided Bone Regeneration. Maxillofac Plast Reconstr Surg. 2014 Nov;36(6):239-46. doi: 10.14402/jkamprs.2014.36.6.239. Epub 2014 Nov 12.

Reference Type BACKGROUND
PMID: 27489841 (View on PubMed)

Fernandes da Silva AL, Borba AM, Simao NR, Pedro FL, Borges AH, Miloro M. Customized polymethyl methacrylate implants for the reconstruction of craniofacial osseous defects. Case Rep Surg. 2014;2014:358569. doi: 10.1155/2014/358569. Epub 2014 Jun 30.

Reference Type BACKGROUND
PMID: 25093139 (View on PubMed)

Freitas de Andrade P, Meza-Mauricio J, Kern R, Faveri M. Labial Repositioning Using Print Manufactured Polymethylmethacrylate- (PMMA-) Based Cement for Gummy Smile. Case Rep Dent. 2021 Dec 21;2021:7607522. doi: 10.1155/2021/7607522. eCollection 2021.

Reference Type BACKGROUND
PMID: 34970460 (View on PubMed)

AlSubaie MF, Al-Sharydah AM, Nassim HM, Alhawsawi A. Orbital Floor Blowout Fracture Reconstruction Using Moldable Polymethyl Methacrylate: A Report of Two Cases and Their Imaging Findings. Open Access Emerg Med. 2022 May 25;14:223-232. doi: 10.2147/OAEM.S359173. eCollection 2022.

Reference Type BACKGROUND
PMID: 35656329 (View on PubMed)

Other Identifiers

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OMFS 3310

Identifier Type: -

Identifier Source: org_study_id

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