- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07624331
Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant Restorations (anatomic)
연구 개요
상세 설명
In recent decades, implant supported restorations have evolved into a well-established therapeutic option for restoring a single missing tooth. One of the key factors contributing to their success is the presence of a well-contoured prosthesis that closely mimics the morphology of adjacent teeth. In addition, the restoration must support the health of hard and soft tissues surrounding the peri-implant mucosa. To replicate the peri-implant soft-tissue contour, the conventional workflow employs an analog impression protocol, which may prone to deformation caused by dimensional changes in impression materials or dental stone. This process also requires longer chairside time and may cause patient discomfort. Considering these limitations, digital impressions obtained using intraoral scanners have been introduced to address these challenges .
With advances in computer-aided design and manufacturing (CAD/CAM), the workflow to fabricate implant restorations is commonly carried out using scan body. Once the implant has osseointegrated, the routine clinical protocol involves disconnection of the titanium standard healing abutment,followed by scanning the scan body , peri-implant mucosa contour, the antagonist arch, and occlusal registration. This workflow, however, requires repeated component disconnections, which may lead to peri-implant mucosal collapse and inaccuracies in soft tissue profile replication. Furthermore, the use of standard healing abutment size often creates a circular soft tissue contour, resulting in an unfavourable emergence profile that may require additional surgery or recontouring. Therefore, reproducing the anatomy of the contralateral tooth with a well-contoured implant restorative emergence profile (IREP) is commonly recommended through the use of a custom healing abutment. Several methods have been introduced to fabricate customized healing abutments, including the chairside addition of flowable composite to temporary abutments. In addition, the computer-aided design and computer-aided manufacturing (CAD/CAM) socket seal abutment (SSA) has been proposed to preserve soft and hard-tissue dimensions following implant placement. This workflow includes an additional step of milling the SSA and cementing it to a temporary abutment during the same surgical appointment. However, this approach carries a risk of contamination and requires additional time and cost. Despite these developments, challenges remain with the current use of standard scan bodies. Most standard scan bodies have a conical or cylindrical shape that fails to replicate the natural morphology of a tooth, especially in posterior molar regions. Furthermore, regardless of the patient's gingival phenotype, peri-implant mucosal collapse occurs rapidly often within 20 seconds after losing the physical support following the removal of the customized healing abutment and insertion of the scan body.This soft tissue deviation may cause unstable mucosal margin and exert excessive pressure when delivering final implant restoration, often leading to additional chairside adjustments. To overcome the peri-implant soft tissue deviation and accurate replication, a novel anatomic healing abutment fabricated from polyetheretherketone (PEEK) has been introduced to capture digital impression without removing the healing abutment. This allows one-step formation of an emergence profile that mimics natural tooth anatomy and may reduce the chairside time. Utilizing a predefined emergence profile in the software library, the AHA eliminates the need for additional soft tissue modification, expedites the prosthetic workflow, and includes an identification code for accurate scanning. Despite these advantages, there is currently no clinical evidence validating the use of AHA for preserving peri-implant soft tissue, improving workflow efficiency, crown-fitting accuracy, or evaluating its impact on patientrelated outcomes. This warrants further investigation through controlled clinical evaluation. Therefore, this study aims to evaluate the dimensional changes of peri-implant soft tissue following implant placement in healed sites before and after crown delivery, to assess the immediate and time-dependent soft-tissue stability after standard healing abutment and AHA removal. Additionally, this study will compare the pink white esthetic score (PESWES) , keratinized mucosa width (KMW) , mesiodistal papilla height variation and patient-related outcomes of digital impression workflows using either a standard scan body or AHA for posterior single-implant restorations.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nur Hafizah Kamar Affendi, master
- 전화번호: +60361266545
- 이메일: hafizah_kamar@uitm.edu.my
연구 연락처 백업
- 이름: NORWATI Atikah Mustafa, phd
- 전화번호: 0361266545
- 이메일: norwati_atikah@uitm.edu.my
연구 장소
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Selangor
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Sungai Buloh, Selangor, 말레이시아, 42300
- 모병
- Universiti Teknologi MARA
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연락하다:
- NUR HAFIZAH AFFENDI, MASTER
- 전화번호: 0361266545
- 이메일: hafizah_kamar@uitm.edu.my
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연락하다:
- 이메일: nfizakama@gmail.com
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수석 연구원:
- Nur Hafizah Kamar Affendi, MASTER
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
legally competent to provide written informed consent form prior to any study related procedures.
- Subjects of either sex or aged 18 above
- requires replacement of a single missing posterior tooth with adequate mesiodistal dimension (≥8 mm)
- intact adjacent teeth on both sides with existing opposing tooth condition
- good oral hygiene, plaque score <25% bpe1
- adequate keratinized mucosa width (kmw) minimum 6 mm at the edentulous site
- adequate bone volume to accommodate the planned dental implant placement of 5.5 mm diameter and 10 mm in length as verifified by Cone Beam Computed Tomography (CBCT)
- adequate interoccusal distance (crown height space) of at least 6mm measured from alveolar crest to the occlusal table.
Exclusion Criteria:
Localized or generalized periodontitis
- Presence of active acute infection
- History of malignancy, radiotherapy or chemotherapy
- Bone metabolic diseases (e.g.: osteogenesis imperfecta, Paget's disease) or current use of medications affecting bone metabolism
- Untreated bruxism or parafunctional habits Docusign Envelope ID: FFD7C6C1-66CB-4359-9662-63230F769528 22
- Severe occlusal discrepancy
- Any medical condition contraindicating implant placement or alter daily activities to a level consistent with ASA (American Society of Anesthesiologist) III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune or psychiatric disorders)
- Subjects in need of bone grafting at the site of intended implantation site.
- Subjects that are pregnant
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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위약 비교기: Group A: Control
Monolithic zirconia screw retained crown conditioned with titanium standard healing abutment (SHA) and fabricated with standard monoscan body
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Titanium healing abutment
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활성 비교기: Group B: PEEK AHA
Monolithic zirconia screw retained crown conditioned and fabricated with AHA digital workflow
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polyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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volumetric soft tissue analysis
기간: 12 months
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Three-dimensional volumetric analysis changes at healed sites before implant placement and after implant crown loading
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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volumetric analysis changes
기간: 12 months
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Three-dimensional volumetric analysis changes of immediate and time-dependent peri-implant soft-tissue dimensional changes
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12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pink Esthetic White Esthetic Score
기간: 12 months
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The PES will be used to evaluate peri-implant soft tissue esthetics and will be assessed at 3 and 12 months after implant placement. PES includes seven parameters: mesial papilla, distal papilla, soft tissue level, soft tissue contour, root convexity, soft tissue color, and soft tissue texture. Each parameter is scored from 0 to 2, where 0 indicates an obvious discrepancy with the contralateral tooth, 1 indicates a minor discrepancy, and 2 indicates no discrepancy. The maximum possible PES is 14, with scores ≥8 considered esthetically acceptable and scores ≥12 indicating an excellent result. The WES will be used to evaluate the esthetic integration of the implant crown and will be assessed based on five parameters: tooth outline, volume, shade, surface texture, and translucency. Each parameter is scored from 0 to 2, following the same scoring criteria as PES. The maximum WES is 10, with scores ≥6 considered esthetically acceptable. |
12 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Professor Dr Mohd Yusmiaidil Putera Mohd Yusoff, phd, Universiti Teknologi MARA
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- REC/11/2025 (ST/FB/28)
- Study IIS 26/25 (기타 보조금/기금 번호: INVESTIGATOR INITIATED STUDIES (IIS))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
standard healing abutment에 대한 임상 시험
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Alexandria University완전한
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Pusan National University Hospital모병
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