- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07657364
Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo, 이집트, 11553
- 모병
- Faculty of Dentistry - Cairo University
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연락하다:
- Faculty of Dentistry - Cairo University
- 전화번호: 0020223642705
- 이메일: dentmail@dentistry.cu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18 years or older.
- Able to understand the study procedures and provide written informed consent.
- In good general health, classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
- Completely edentulous in the arch to be treated (maxilla and/or mandible).
- A candidate for a full-arch, screw-retained implant-supported prosthesis, requiring 4 to 6 implants in the treatment arch.
- Sufficient bone volume at planned implant sites to place implants of at least 3.5mm in diameter and 8mm in length.
- Adequate crown height space (15-22 mm) for a fixed prosthesis.
- A zone of keratinized mucosa at the crest of the ridge measuring at least 2 mm in width.
- Opposing arch is fixed full-arch implant-supported prosthesis.
- Demonstrates acceptable oral hygiene and the motivation to maintain it.
Exclusion Criteria:
Medical contraindications:
- Uncontrolled diabetes (HbA1c > 7.0%).
- History of radiotherapy in the head and neck region.
- History of intravenous bisphosphonate therapy.
- Immunosuppressed or immunocompromised status.
- Any other uncontrolled systemic disease that constitutes a contraindication for oral surgery.
Behavioral Factors:
- Heavy smoking, defined as consumption of more than 10 cigarettes per day.
- Presence of parafunctional habits (e.g., bruxism, clenching) as diagnosed by clinical examination.
Local Oral Factors:
- Active, untreated periodontal disease in any remaining dentition.
- Presence of acute oral infection or pathology at the intended surgical site.
- Crown height space less than 15 mm or more than 22 mm.
- Insufficient keratinized mucosa (< 2 mm width) that cannot be corrected with a simple surgical procedure prior to implant placement.
General:
- Pregnancy or lactation.
- Participation in another interventional clinical trial.
- Perceived inability to comply with the study protocol and follow-up schedule.
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: Monolithic zirconia framework
The prosthesis is a one-piece, full-arch framework milled from a single, monolithic zirconia blank.
It includes the infrastructure, prosthetic teeth, and gingival contours.
The prosthesis is screw-retained directly to multi-unit abutments.
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Intervention: Screw-Retained Monolithic Zirconia Prosthesis
다른 이름들:
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활성 비교기: CNC-milled titanium framework and zirconia superstructure
The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework. The titanium framework is screw-retained directly to multi-unit abutments. The zirconia superstructure is permanently cemented to the framework with resin cement. |
The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework.
The titanium framework is screw-retained directly to multi-unit abutments.
The zirconia superstructure is permanently cemented to the framework with resin cement.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Prosthetic complications
기간: 1 year
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The primary outcome of this study is the incidence of prosthetic complications over 12-month follow-up period.
A prosthetic complication is defined as any mechanical or technical issue affecting the prosthesis that requires clinical intervention.
This will be assessed through a standardized clinical examination conducted by a calibrated examiner.
The outcome for each participant will be recorded as a binary variable (Yes/No).
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Oral Health-Related Quality of Life (OHRQoL)
기간: 1 year
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The secondary outcome of this study is the change in Oral Health-Related Quality of Life (OHRQoL) over the 12-month follow-up period.
This will be measured using the validated Arabic version of the 5-item Oral Health Impact Profile (OHIP5-Ar) questionnaire (Alhajj et al., 2019).
The questionnaire consists of 5 questions, each rated on a Likert scale (e.g., 0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, 4 = Very often).
The total score ranges from 0 to 20, with a higher score indicating a greater negative impact on OHRQoL.
The change from baseline to 3, 6 and 12 months will be analyzed.
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1 year
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공동 작업자 및 조사자
스폰서
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
기타 연구 ID 번호
- 09062026
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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