폴리메틸메타크릴레이트(PMMA) 멤브레인을 사용한 GBR(유도 뼈 재생)로 재생된 뼈 평가
수평 결함이 있는 상악 미적 영역에서 맞춤형 3D 프린팅 PMMA(폴리메틸메타크릴레이트) 막을 사용하여 유도 뼈 재생(GBR) 후 재생된 뼈 평가
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo Governorate
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Cairo, Cairo Governorate, 이집트, 11553
- Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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다른: 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. |
guided bone regeneration (GBR) using polymethylmethacrylate (PMMA) polymer as membrane.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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amount of bone gain
기간: 6 months postoperative
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radiographic using cone beam computed tomography (CBCT) |
6 months postoperative
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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quality of bone regenerated
기간: 6 months after surgical procedure
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bone 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. |
6 months after surgical procedure
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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post operative ridge width
기간: 6 months postoperative
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using bone caliper |
6 months postoperative
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initial implant stability
기간: 6 months post operative
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using manual ratchet |
6 months post operative
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Hesham El Hawary, Professor of Oral and Maxillofacial surgery, Cairo university
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- OMFS 3310
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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