- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00545818
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Apeldoorn, 네덜란드, 7315
- Praktijk De Mondhoek
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California
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Los Angeles, California, 미국, 90089-0641
- USC School of Dentistry
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Iowa
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Iowa City, Iowa, 미국, 52242-1010
- The University of Iowa, College of Dentistry
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Göteborg, 스웨덴, SE 405 30
- Dept. of Parodontology, Göteborg University
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London, 영국, SE1 9RT
- King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
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Victoria
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Melbourne, Victoria, 호주, 3010
- School of Dental Science, University of Melbourne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Provision of informed consent
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
- Deemed by the investigator as likely to present an initially stable implant situation
Exclusion Criteria:
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study.
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group-1, Implant length 6 mm
Subjects treated with OsseoSpeed™ implant, length: 6 mm
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OsseoSpeed™ dental implant, length: 6 mm
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다른: Group-2, Implant length 11 mm
Subjects treated with OsseoSpeed™ implant, length: 11 mm
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OsseoSpeed™ dental implant, length: 11 mm
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Radiological Assessments of Marginal Bone Level Alteration
기간: Evaluated from implant installation to 5 years follow-up after implant placement
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Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. |
Evaluated from implant installation to 5 years follow-up after implant placement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Implant Survival
기간: Evaluated 5 years after implant placement
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Overall implant survival, measured on implant level
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Evaluated 5 years after implant placement
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Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
기간: Measured at the 5-year follow-up visit after loading
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Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP).
Presented as s count of implants that show presence of BoP.
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Measured at the 5-year follow-up visit after loading
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Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
기간: Evaluated at implant loading and at the 5-year follow-up visit.
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Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
Evaluated at implant loading and at the 5-year follow-up visit.
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Presence of Plaque
기간: Evaluated at the 5-year follow-up visit after loading.
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Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing. |
Evaluated at the 5-year follow-up visit after loading.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Anna-Karin Lundgren, Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
간행물 및 유용한 링크
일반 간행물
- Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
- Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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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