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

NCT06186232 | Not Yet Recruiting

• 1 other identifier: OMFS 3310
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Horizontal Ridge Deficiency

Keywords

polymethylmethacrylate

Outcome Measures

Primary Outcomes (1)

• amount of bone gain

  radiographic using cone beam computed tomography (CBCT)

  6 months postoperative

Secondary Outcomes (1)

• quality of bone regenerated

  6 months after surgical procedure

Other Outcomes (2)

• post operative ridge width

  6 months postoperative

• initial implant stability

  6 months post operative

Study Arms (1)

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

guided bone regeneration (GBR). PROCEDURE

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

Also known as: implant installation 6 months after (GBR)

patient with horizontally deficient ridge in ethetic maxilary zone need (GBR) and implant placement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (7)

• 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.

  PMID: 29264297 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.

  PMID: 25123759 BACKGROUND

• 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.

  PMID: 28833567 BACKGROUND

• 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.

  PMID: 27489841 BACKGROUND

• 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.

  PMID: 25093139 BACKGROUND

• 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.

  PMID: 34970460 BACKGROUND

• 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.

  PMID: 35656329 BACKGROUND

Study Officials

• Hesham El Hawary

  Professor of Oral and Maxillofacial surgery, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Rana Sherif

CONTACT

01095306060; rana-mohamed@dentistry.cu.edu.eg

Eman Sayed

CONTACT

eman.shalaby@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluation Of Bone Regenerated After Guided Bone Regenration (GBR) using customized 3D printed Polymethylmethacrylate (PMMA) membrane in horizontally deficient maxillary aesthetic zone.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08