Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant Restorations (anatomic)
研究概览
地位
地位
条件
条件
干预/治疗
干预/治疗
详细说明
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.
研究类型
研究类型
注册 (估计的)
注册
阶段
阶段
- 不适用
联系人和位置
学习联系方式
学习联系方式
- 姓名:Nur Hafizah Kamar Affendi, master
- 电话号码:+60361266545
- 邮箱:hafizah_kamar@uitm.edu.my
研究联系人备份
- 姓名:NORWATI Atikah Mustafa, phd
- 电话号码:0361266545
- 邮箱:norwati_atikah@uitm.edu.my
学习地点
-
-
Selangor
-
Sungai Buloh、Selangor、马来西亚、42300
- 招聘中
- Universiti Teknologi Mara
-
接触:
- NUR HAFIZAH AFFENDI, MASTER
- 电话号码:0361266545
- 邮箱:hafizah_kamar@uitm.edu.my
-
接触:
-
首席研究员:
- Nur Hafizah Kamar Affendi, MASTER
-
-
参与标准
资格标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
安慰剂比较:Group A: Control
Monolithic zirconia screw retained crown conditioned with titanium standard healing abutment (SHA) and fabricated with standard monoscan body
|
Titanium healing abutment
|
|
有源比较器:Group B: PEEK AHA
Monolithic zirconia screw retained crown conditioned and fabricated with AHA digital workflow
|
polyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment
|
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
volumetric soft tissue analysis
大体时间:12 months
|
Three-dimensional volumetric analysis changes at healed sites before implant placement and after implant crown loading
|
12 months
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
volumetric analysis changes
大体时间:12 months
|
Three-dimensional volumetric analysis changes of immediate and time-dependent peri-implant soft-tissue dimensional changes
|
12 months
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pink Esthetic White Esthetic Score
大体时间:12 months
|
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
|
合作者和调查者
调查人员
调查人员
- 研究主任:Professor Dr Mohd Yusmiaidil Putera Mohd Yusoff, phd、Universiti Teknologi Mara
研究记录日期
研究主要日期
学习开始 (估计的)
学习开始
初级完成 (估计的)
初级完成
研究完成 (估计的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他研究编号
其他研究编号
- REC/11/2025 (ST/FB/28)
- Study IIS 26/25 (其他赠款/资助编号:INVESTIGATOR INITIATED STUDIES (IIS))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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