- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07619846
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery (BRT-SINUS)
Evaluation of Effectiveness of Bone Ring Technique in One Stage Surgery of External Maxillary Sinus Lifting With Implantation: A Prospective Case Series
연구 개요
상세 설명
The Bone Ring Technique (BRT) was introduced by Giesenhagen (2004) to address severe posterior maxillary atrophy. In this prospective single arm case series, after obtaining ethics approval (DN 28102025 542, Damascus University), ten patients with residual bone height ≤4 mm will undergo: harvesting of an 8 mm cylindrical autogenous bone ring from the mandibular symphysis using trephine burs; creation of a lateral window in the maxillary sinus using a straight handpiece with a diamond round bur; meticulous elevation of the Schneiderian membrane; placement of the bone ring; simultaneous insertion of a dental implant (ICX) through the ring into the native ridge; filling of the defect with xenograft (bovine) particles; coverage with a collagen membrane; and suturing Primary stability will be measured immediately after implantation using resonance frequency analysis (Mega ISQ II).
CBCT scans (PaX i3D, VATECH) will be performed preoperatively, at 1 week, and at 6 months to quantify vertical bone gain (distance from implant shoulder to sinus floor) and peri implant bone density (Hounsfield like units).
Clinical follow up includes suture removal at 7 10 days and assessment of implant survival/success at 6 months (absence of mobility, pain, radiolucency, suppuration, crestal bone loss <1.5 mm).
Results will be submitted for publication in a peer reviewed journal.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Adel Alassaf, DDS
- 전화번호: +963 949038706
- 이메일: sx19adel@gmail.com
연구 장소
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Governorate
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Damascus, Governorate, 시리아, 4671
- 모병
- Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Mezzeh Highway, Damascus, Syria
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Need for dental implant in posterior maxilla (premolar/molar).
- Residual alveolar bone height ≤4 mm on preoperative CBCT.
- Age ≥18 years.
- Controlled systemic health.
- Able to comply with procedures and follow up.
- Good oral hygiene.
- Signed written informed consent.
Exclusion Criteria:
- Uncontrolled systemic disease.
- Head/neck radiotherapy.
- Bisphosphonate therapy >3 years.
- Autoimmune disease affecting healing.
- Pregnancy/lactation.
- Active maxillary sinus pathology (sinusitis, cysts, polyps, tumours).
- Heavy smoking (>10 cigarettes/day).
- Severe bruxism.
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: Bone Ring Technique (BRT)
Eligible patients with posterior maxillary atrophy (RBH ≤4 mm) will undergo a single surgical session.
Preoperatively, CBCT will be performed.
Under local anesthesia, the surgeon will harvest an autogenous bone ring from the chin (mandibular symphysis) using trephine burs.
A lateral window will be created in the maxillary sinus wall using a straight handpiece with a diamond round bur.
The sinus membrane will be elevated, and the bone ring will be placed into the sinus.
A dental implant (ICX) will be inserted through the ring into the residual ridge.
The defect will be filled with xenograft particles and covered with a collagen membrane.
Sutures will be removed at 7-10 days.
Patients will be followed for 6 months with clinical and CBCT evaluations.
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The Bone Ring Technique (BRT) is a one-stage surgical procedure that combines external maxillary sinus floor elevation with simultaneous dental implant placement.
An autogenous bone ring is harvested from the mandibular symphysis using trephine burs.
The sinus membrane is elevated via a lateral window approach created with a straight handpiece and diamond round bur.
The bone ring is then placed into the sinus cavity, and a dental implant is inserted through the ring into the residual alveolar bone.
The surgical site is augmented with xenograft particles and covered with a collagen membrane.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Implant Stability Quotient (ISQ).
기간: Immediately after implant placement (baseline) and 6 months post_surgery (before prosthetic loading).
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Measured by resonance frequency analysis with MEGA ISQ II (MegaGen, Korea), Four readings per implant (mesial, distal, buccal, lingual); mean value reported
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Immediately after implant placement (baseline) and 6 months post_surgery (before prosthetic loading).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vertical Bone Gain (mm)
기간: at preoperative, 1 week post_surgery , 6 months post_surgery
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Distance from implant shoulder to highest point of elevated sinus floor; measured on coronal sections using Ez3D plus software
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at preoperative, 1 week post_surgery , 6 months post_surgery
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Peri implant Bone Density (gray values)
기간: at preoperative, 1 week post_surgery , 6 months post_surgery
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regions of interest: coronal, middle, apical thirds
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at preoperative, 1 week post_surgery , 6 months post_surgery
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Implant Survival & Success
기간: 6 months post_surgery
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Survival = implant in situ.
Success = absence of mobility, persistent pain, peri implant radiolucency, suppuration; and crestal bone loss <1.5 mm on CBCT.
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6 months post_surgery
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공동 작업자 및 조사자
수사관
- 연구 책임자: Khaldoun Darwich, DDS MSc PhD, Damascus University Syria
간행물 및 유용한 링크
일반 간행물
- Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
- Alchalabi NJ, Merza AM, Issa SA. Using Carnoy's Solution in Treatment of Keratocystic Odontogenic Tumor. Ann Maxillofac Surg. 2017 Jan-Jun;7(1):51-56. doi: 10.4103/ams.ams_127_16.
- Giesenhagen B, Martin N, Donkiewicz P, Peric Kacarevic Z, Smeets R, Jung O, Schnettler R, Barbeck M. Vertical bone augmentation in a single-tooth gap with an allogenic bone ring: Clinical considerations. J Esthet Restor Dent. 2018 Nov;30(6):480-483. doi: 10.1111/jerd.12392. Epub 2018 Aug 2.
- Giesenhagen B, Martin N, Jung O, Barbeck M. Bone Augmentation and Simultaneous Implant Placement with Allogenic Bone Rings and Analysis of Its Purification Success. Materials (Basel). 2019 Apr 19;12(8):1291. doi: 10.3390/ma12081291.
- Sleman N, Khalil A. Autogenous bone ring augmentation and simultaneous implant placement in the atrophic posterior maxilla: A case report. Int J Surg Case Rep. 2025 Feb;127:110970. doi: 10.1016/j.ijscr.2025.110970. Epub 2025 Jan 27.
- Nunes MP, Nunes LFP, Filho DPN, Pinho RCM, Cimoes R. Bone Ring Technique for the Treatment of Vertical and Horizontal Bone Defects with Immediate Implants: A Report of Two Cases. Int J Periodontics Restorative Dent. 2021 May-Jun;41(3):413-421. doi: 10.11607/prd.4401.
- Nunes MP, Nunes LFP, Ribeiro JCB, Mourao Pinho RC, Cimoes R. Maxillary Sinus Elevation Using the Bone Ring Technique with Immediate Implantation: A Case Report. Int J Periodontics Restorative Dent. 2022 Jul-Aug;42(4):525-533. doi: 10.11607/prd.4746.
- Arab HR, Moeintaghavi A, Shiezadeh F, Nezhad MH. Crestal Sinus Floor Elevation with Autogenous Press-Fit Dowel Bone Harvested Using Trephine Drills: A New Method. J Long Term Eff Med Implants. 2018;28(3):209-214. doi: 10.1615/JLongTermEffMedImplants.2018017280.
- Saez-Alcaide LM, Brinkmann JC, Sanchez-Labrador L, Perez-Gonzalez F, Molinero-Mourelle P, Lopez-Quiles J. Effectiveness of the bone ring technique and simultaneous implant placement for vertical ridge augmentation: a systematic review. Int J Implant Dent. 2020 Dec 12;6(1):82. doi: 10.1186/s40729-020-00280-0.
- Flanagan D. Cylindrical Ringbone Allograft to Restore Atrophic Implant Sites: A Pilot Study. J Oral Implantol. 2016 Apr;42(2):159-63. doi: 10.1563/aaid-joi-D-15-00052. Epub 2015 Sep 8.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- UDDS-2026-OralMaxillofacial-01
- DN-28102025-542 (기타 식별자: Ethics committee, Damascus University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data that underlie the results reported in the publication, specifically: Implant Stability Quotient (ISQ) values, vertical bone gain measurements (mm), and peri-implant bone density values (Hounsfield-like units).
Beginning 6 months after publication of the primary results. Data will be available for a period of 3 years.
With Researchers who submit a methodologically sound research proposal to the principal investigator, To achieve the aims specified in the approved research proposal, particularly for individual participant data meta-analysis or secondary analyses of maxillary sinus augmentation techniques
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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. .