- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07697066
Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
Influence of Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
연구 개요
상태
상세 설명
A dental implant is a method for the replacement of lost teeth, with an excellent prospering percentage plus lasting functional rehabilitation without requiring any preparation of the nearby teeth.
The usage of a healing abutment is one of the crucial clinical procedures that follows implant placement. It aids in establishing a stable and natural gingival emergence profile by supporting soft tissue shaping and shielding the implant platform. Various materials are available for healing abutments, which have an impact on biocompatibility, aesthetic results, soft tissue reaction, and patient comfort throughout the healing process.
Polyether ether ether ketone (PEEK) healing abutments are offering a non-metallic, lightweight option with a modulus of elasticity similar to bone, but they have lower surface hardness compared to titanium and zirconia, and long-term data is still developing.
3D printed hybrid resin materials were introduced earlier, allowing faster and precise fabrication of permanent dental restorations. P-Crown V4 material is a newly introduced 3D-printed nanoceramic-filled resin reported to contain up to 70% nanoceramic filler to enhance strength and hardness.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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El-Gharbia
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Tanta, El-Gharbia, 이집트, 31773
- Tanta University - Faculty of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patient's aged 25-45 years old
- Patients with missing tooth needing solitary implant placement rehabilitation in the maxillary anterior regions with neighboring and opposite normal teeth.
- Adequate mesial, distal, and interocclusal space for implant engagement and its absolute re-establishment.
- Patients can recite and mark the informed approval paper.
- Medically free patients or with controlled systemic disease.
- Patients with acceptable bone quality and quantity.
- Patients can return for follow-up examinations and evaluation.
- Patients with good oral hygiene.
- Nasal floor clearance from root apex at least 4 mm.
Exclusion Criteria:
- Patients with inappropriate implantation situates (patients with foremost bony deficiencies or sever bone resorption).
- Patient with severe clenching or bruxism.
- Heavy smokers or drug abusers.
- Psychiatric complications or impractical prospects.
- Patients with bad oral hygiene.
- Systemic conditions that may impact soft or hard tissue curing.
- Patients with history of radiation treatment in the head and neck area.
- Pregnant female
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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활성 비교기: Group I
Patients received a standard ready-made titanium healing abutment (control group).
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Patients received a standard ready-made titanium healing abutment (control group).
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실험적: Group II
Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
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Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
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실험적: Group III
Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.
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Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Modified Plaque Index
기간: Two months after healing abutment placement
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The Modified Plaque Index was used to assess the degree of Plaque Accumulation. 0 No plaque
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Two months after healing abutment placement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Modified gingival index
기간: Two months after healing abutment placement
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The modified gingival index was used to assess the gingival condition. Each surface was evaluated and assigned a score from 0 to 4: 0 No bleeding
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Two months after healing abutment placement
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Papilla index (Jemt Index)
기간: Two months after healing abutment placement
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The papilla index (Jemt Index) was used to assess the Papilla condition. 0 No papilla present; no soft tissue curvature; empty space present.
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Two months after healing abutment placement
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공동 작업자 및 조사자
스폰서
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
- R-FP-11-25-3233
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
끼워 넣다에 대한 임상 시험
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Cairo University아직 모집하지 않음
Titanium healing abutment에 대한 임상 시험
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Alexandria University완전한
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University of ValenciaUniversity of Santiago de Compostela완전한
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Pusan National University Hospital모병
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Healing InnovationsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Kessler Foundation아직 모집하지 않음뇌졸중 | 편마비 | 보행 장애, 신경학적 | 이동성 제한 | 균형 장애 | 편마비, 뇌졸중 후/CVA | 낙상 예방 | 신경학적 질병 또는 상태 | 뇌졸중 후 피로 | 운동 회복 | 보행 장애미국
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Dentsply Sirona Implants and Consumables모집하지 않고 적극적으로
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Dentsply Implants Manufacturing GmbH완전한
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University of PennsylvaniaMarch of Dimes모병
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Bioventus LLCMcMaster University; Clinical Advances Through Research and Information Translation종료됨