- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07589426
Horizontal Ridge Augmentation in Maxillary Esthetic Zone Using Bovine Bone Graft Versus Extended Sticky Bone With Simultaneous Implant Placement
연구 개요
상세 설명
Patient selection This study will involve sixteen implants inserted in patients with missing upper tooth / teeth in the esthetic zone accompanied by horizontal alveolar ridge resorption, seeking future tooth replacement. The patients will be selected from the Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University
Inclusion Criteria:
- Patient aged 18-45 years.
- Cooperative patient with high motivation and acceptable oral hygiene.
- Maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification). (22)
- No deep undercut at the ridge in the buccal aspect.
- The presence of enough keratinized gingiva(≥3mm).(23)
- Sufficient inter-arch space to accommodate the future prosthesis. (24)
- Patients able to comply with the required recall visits.
Exclusion criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery
- Smokers
- Pregnancy.
- Parafunctional habits, including bruxism and clenching.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Al Mansurah, 이집트
- Mansoura University
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Al Mansurah, 이집트
- Amira Attia
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patient aged 18-45 years, Cooperative patient with high motivation and acceptable oral hygiene, maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification) (24),No deep undercut at the ridge in the buccal aspect, The presence of enough keratinized gingiva(≥3mm).(25), sufficient inter-arch space to accommodate the future prosthesis. (26) , and Patients able to comply with the required recall visits.
Exclusion Criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery, smokers, pregnancy and parafunctional habits, including bruxism and clenching.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using Medpark
For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site.
For group II, extended sticky bone (ESB) was prepared by centrifugation of autologous blood followed by preparation of ALB-PRF and mixing with bone particulates (50:50 allograft: xenograft) to obtain the final graft materia
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The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
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실험적: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using extended
|
The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Implant Stability Quotient (ISQ) Values Assessed by Resonance Frequency Analysis
기간: Baseline and 6 months after implant placement
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Implant stability was assessed using resonance frequency analysis (RFA) with the Osstell device and expressed as Implant Stability Quotient (ISQ) values. ISQ scores range from 1 to 100, with higher scores indicating greater implant stability and osseointegration. High stability: ISQ > 70 Medium stability: ISQ 60-69 Low stability: ISQ < 60 Measurements were recorded immediately after implant placement and at the 6-month follow-up. |
Baseline and 6 months after implant placement
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- Ms.25.04.21
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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Horizontal Alveolar Ridge Resorption에 대한 임상 시험
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