- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07657026
Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant. (BMAC)
Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study
연구 개요
상세 설명
Zygomatic implants provide a viable option for rehabilitation of the severely atrophic maxilla. However, achieving optimal osseointegration remains a challenge due to poor bone quality in the posterior maxilla. Bone marrow aspirate concentrate contains mesenchymal stem cells and growth factors that may enhance local bone formation.
Knowledge Gap:
BMAC has been investigated with conventional dental implants, but its use with zygomatic implants placed via the intrasinus approach is limited to isolated case reports. A systematic evaluation of its effect on peri-implant bone density and stability in this specific context is lacking. This case series addresses that gap.
Study Design and Setting:
This is a single-center, prospective case series planned at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. The primary hypothesis is that BMAC application will improve bone density and secondary stability of zygomatic implants at 6 months. (Recruitment has not commenced.)
Surgical Procedure:
Under general anaesthesia, approximately 30 ml of bone marrow will be aspirated from the anterior iliac crest. The aspirate will be processed using a double centrifugation protocol to obtain the buffy coat layer, which will then be loaded onto a gelatine sponge. Zygomatic implants will be placed through a lateral sinus window using the intrasinus trajectory. The BMAC-loaded sponge will be applied around the implant prior to closure. Conventional implants will be placed in the anterior maxilla to support the planned full-arch prosthesis.
Follow-up Protocol:
Patients will be reviewed weekly during the first month, then monthly for 6 months. Cone beam computed tomography will be performed immediately postoperatively and at 6 months to assess changes in bone density in Hounsfield Units. Resonance frequency analysis will be performed at 6 months to evaluate secondary implant stability. Adverse events will be recorded throughout the follow-up period.
Ethical Considerations:
The study protocol has been submitted to the Ethics Committee of Scientific Research, Faculty of Dentistry, Cairo University and is currently pending approval. A written informed consent will be obtained from all participants in Arabic prior to enrollment. Patient data will be coded and stored in a secure, password-protected database accessible only to the research team. The study is self-funded with no conflicts of interest declared.
Outcomes:
The primary outcome is the change in peri-implant bone density at 6 months. Secondary outcome includes secondary stability of the implants . Data will be summarized descriptively given the case series design.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tilal Sidahmed Ahmed, BDS
- 전화번호: 00201555225441
- 이메일: Tilal.sidahmed@dentistry.cu.edu.eg
연구 연락처 백업
- 이름: Walaa Kadry Hafez, Associate professor of OMFS
- 전화번호: 00201061527359
- 이메일: walaakadry@dentistry.cu.edu.eg
연구 장소
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Cairo Governate
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Cairo, Cairo Governate, 이집트, 11562
- Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients over 18 years old.
- Patients requiring rehabilitation with zygomatic implants in the posterior maxilla.
- Patients who are willing to participate and able to provide informed consent.
Exclusion Criteria:
- Pregnant women.
- Individuals with history of radiation therapy or other contraindications for surgery.
- Patients with bone marrow diseases.
- Patients with local infections at intraoral surgical site or bone marrow aspiration site.
- Patients unwilling to sign the written informed consent.
- Heavy smokers >20 cigarettes per day.
- Patients taking contraindicated drugs such as bisphosphonates.
- Patients with sinus pathology or acute sinusitis.
- Patients with malignancy or pathology of maxilla.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: zygomatic implant group
All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.
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placement of zygomatic implants via the intrasinus approach in the posterior maxilla of patients with severely atrophied maxilla.
Bone marrow aspirate concentrate prepared by double centrifugation of bone marrow aspirated from anterior iliac crest of the patient then loaded on gelatine sponge and applied around the zygomatic implants.
Conventional implants may be placed in the anterior maxilla.
Procedure performed under general anaesthesia with propofol induction and sevoflurane maintenance.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bone density around zygomatic implants
기간: 6 months postoperatively
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Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)
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6 months postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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secondary stability of zygomatic implants
기간: 6 months postoperatively
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Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)
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6 months postoperatively
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Ramy Ragab Elbeialy, Professor of OMFS, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- omfs3-3-20-
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared due to ethical restrictions and patient privacy regulations.
IPD will be shared after publication.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
zygomatic implants placement에 대한 임상 시험
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