- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07669792
Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis)
Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis): A Randomized Clinical Trial
연구 개요
상태
상세 설명
The aim of this study is to assess the bone gained histologically when comparing the following different techniques:
One of the techniques that is used for bone augmentation is the Khoury technique which entails that a split cortical bone shell obtained from the ramus area through piezoelectric surgery. The thin laminae of bone obtained is stabilized in the defect area labially through micro screws and the generated gap is filled through a mixture of autogenous that could be obtained from the retromolar area through special burs as the auto chip maker (ACM) or via bone scrapper. The obtained is mixed with an equal ratio with xenograft or bone obtained from animal source to fill the created gap.
Another technique involves the usage of a non-resorbable membrane known as reinforced titanium PTFE that is stabilized from both the lingual and labial aspects via micro screws .It's then filled with a mixture of both autogenous and xenograft for maximizing the bone formation capability. In some cases, the reinforced titanium PTFE is covered with collagen membrane to avoid one of the common drawbacks of this technique which is wound dehiscence.
This study aims to evaluate the bone quality gained from both techniques.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Abdelaziz H. Saad Abdelkarim, Bachelor's Degree
- 전화번호: +201020690459
- 이메일: PG.Abdelaziz92344012@bue.edu.eg
연구 장소
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Cairo, 이집트
- 모병
- The British University in Egypt
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연락하다:
- Oral and Maxillofacial Lecturer
- 전화번호: +201005609359
- 이메일: Moataz.Bahaa@bue.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Have two or more missing teeth in the posterior mandibular segment.
- The patients age of 18 and above.
- The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 4mm.
- Sufficient vertical bone height.
- Free of any local or systemic condition that may contraindicate ridge expansion procedure.
Exclusion Criteria:
- Patients taking any medication that may interfere with bone healing or bone biology.
- Patients with any systemic disease that may affect bone healing.
- Any patients with any previous bone grafting procedure at the site of interest.
- Smokers.
- Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
- Patients with significant vitamin D deficiency.
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 |
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실험적: GBR using Ti based PTFE
This group will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane.
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Patients will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane with full releasing flap buccal and lingual with the lingual dissection for the releasing of the mylohyoid attachment and nerve dissection of the mental nerve buccally.
The membrane needs to be fixed lingually with microscrews or titanium screws then the gap will be filled through Auto Chip Maker ACM or bone scraper from the external oblique ridge.
Then the harvested bone shall be mixed xenograft with ratio 70 to 30 then the membrane fixed buccally as well as covered by collagen membrane to avoid one of the main obstacles of the procedure which is wound dehiscence.
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활성 비교기: Bone Shell Khoury's Technique
This group will receive a block graft using Khoury Technique.
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A block graft using Khoury Technique: Prior to harvesting the needed bone, measurement of the defect size as well as measurement of the donor site bone block will be harvested from the mandibular retromolar area.
The bone shall be acquired through piezoelectric device that perform the osteotomy then separated through the usage of thin chisel.
The acquired bone needs to be smoothened to avoid any sharp edge that may cause wound dehiscence or infection.
The harvested bone will be divided into two thinner bone shells through using titanium disk with copious irrigation with saline.
The bone shell shall be fixated in the defect site buccally through two microscrews at least then the created space shall be filled with a combination of autogenous bones harvested through Auto Chip Maker (ACM) or bone scraper from the external oblique ridge.
The harvested bone will be combined with xenograft with ratio 70 to 30 then the defect shall be covered with collagen membrane.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Histomorphometric analysis of gained bone
기간: 6 Months
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Primary evaluation is achieved through re opening of the flap after 6 months for removing the microscrews used in Khoury group and the nonresorbable membrane as well as the screws will be removed from the nonresorbable membrane group.
Then the usage of 2 millimeters bur for core biopsy at the site of the implant that will be placed.
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6 Months
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공동 작업자 및 조사자
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 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. .
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