- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07670559
Carrot Technique Versus Guided Bone Regeneration for Horizontal Ridge Deficiency in the Maxillary Esthetic Zone
Evaluation of the Carrot Technique With Simultaneous Implant Placement for Horizontal Alveolar Ridge Deficiency in the Maxillary Aesthetic Zone: A Randomized Controlled Clinical Trial.
연구 개요
상태
상세 설명
The Carrot Technique is a minimally invasive approach that utilizes an autogenous bone core harvested during implant osteotomy and repositioned to augment the deficient buccal ridge. This technique may reduce donor-site morbidity while providing sufficient horizontal bone augmentation. Guided Bone Regeneration remains one of the most widely used techniques for horizontal ridge reconstruction through the use of bone substitute materials and barrier membranes.
This randomized controlled clinical trial will compare the clinical and radiographic outcomes of the Carrot Technique and GBR in patients presenting with horizontal ridge deficiency in the maxillary esthetic zone. Twenty patients requiring single-tooth implant rehabilitation will be randomly allocated into two equal groups. Group I will receive implant placement combined with the Carrot Technique, while Group II will receive implant placement combined with Guided Bone Regeneration.
Clinical evaluations will include implant stability assessed by resonance frequency analysis, soft tissue healing using the Landry Healing Index, and peri-implant inflammation using the modified sulcus bleeding index. Radiographic evaluation will be performed using cone beam computed tomography immediately after surgery and at 6 and 12 months postoperatively to assess changes in alveolar ridge width, bone density, and marginal bone loss. The study aims to determine whether the Carrot Technique provides comparable or superior outcomes to GBR for horizontal ridge augmentation associated with implant placement.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Al Mansurah, 이집트
- Faculty of Dentistry, Mansoura University
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, 이집트, 35511
- Faculty of Dentistry, Mansoura University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18 to 45 years. Missing a single tooth in the maxillary esthetic zone requiring implant placement.
Good oral hygiene and patient compliance. Medically free from systemic diseases that contraindicate implant surgery. Slight to moderate horizontal alveolar ridge deficiency with a minimum ridge width of 5 mm.
Adequate vertical bone height for implant placement. Medium to hard bone quality (D2-D3 according to Misch classification). Absence of bruxism or other parafunctional habits.
Exclusion Criteria:
- Presence of local pathological lesions (e.g., cysts or tumors) at the planned surgical site.
Poor bone quality (D4 bone). Pregnancy. Heavy smoking. Any medical condition contraindicating implant surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Carrot Technique
Implant placement with horizontal ridge augmentation using an autogenous bone core harvested with a trephine drill from the implant osteotomy site and fixed buccally using osteosynthesis screws.
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Implant placement with simultaneous horizontal ridge augmentation using an autogenous bone core harvested from the implant osteotomy site with a trephine drill and fixed buccally using osteosynthesis screws.
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활성 비교기: Guided Bone Regeneration
Implant placement with horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
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Implant placement with simultaneous horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Alveolar Ridge Width
기간: baseline and 12 Months
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Horizontal alveolar ridge width measured using cone beam computed tomography (CBCT).
Changes in ridge width will be calculated by comparing measurements obtained immediately after surgery and at follow-up.
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baseline and 12 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Marginal Bone Loss
기간: 12 Months
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Marginal bone loss measured radiographically using CBCT using the implant as a reference.
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12 Months
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Soft Tissue Healing
기간: 1 Week, 2 Weeks, and 1 Month
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Soft tissue healing assessed using the Landry Healing Index.
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1 Week, 2 Weeks, and 1 Month
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Modified Sulcus Bleeding Index
기간: 1 Month and 12 Months
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Peri-implant soft tissue inflammation assessed using the Modified Sulcus Bleeding Index (mBI).
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1 Month and 12 Months
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Bone Density
기간: 12 Months
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Buccal peri-implant bone density measured using CBCT and expressed in Hounsfield Units.
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12 Months
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Implant Stability Quotient (ISQ)
기간: At implant placement and 12 months
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Implant stability assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ).
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At implant placement and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sarah A Elmaghraby, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
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
키워드
기타 연구 ID 번호
- R.26.02.103
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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