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Buccal Prosthetic Contour Angles and Peri-Implant Tissue Changes Around Dental Implants (B-PROFILE)

2026年6月4日 更新者:Chang Gung Memorial Hospital

Association Between Buccal Prosthetic Profile Angles at Different Supraplatform Zones and Peri-Implant Tissue Remodeling Around Bone-Level Implants: A Retrospective CBCT-Based Cohort Study

This retrospective observational study aims to evaluate the association between buccal prosthetic profile angles at different supraplatform zones and peri-implant tissue changes around bone-level dental implants restored with customized abutments and crowns. The main questions it aims to answer are:

Whether prosthetic profile angles within different vertical zones above the implant platform (0-2 mm and 2-4 mm) demonstrate different associations with marginal bone level changes around dental implants.

Whether buccal prosthetic contour angles at different supraplatform depths are associated with peri-implant soft tissue conditions, including keratinized tissue width and mucosal changes.

Whether peri-implant phenotype-related factors, including mucosal tunnel depth, soft tissue thickness, and buccal bone thickness, are associated with peri-implant tissue remodeling.

Researchers will retrospectively analyze clinical records, intraoral photographs, radiographic images, and cone-beam computed tomography (CBCT) scans collected during routine implant treatment and follow-up care up to 1 year after prosthetic loading. Buccal prosthetic contour angles will be measured at different vertical zones above the implant platform to evaluate the biologic influence of contour configuration at different peri-implant tissue levels.

研究概览

详细说明

This retrospective observational cohort study aims to evaluate the association between buccal prosthetic profile angles at different supraplatform vertical zones and peri-implant tissue remodeling around bone-level dental implants restored with customized abutments and crowns. Although prosthetic emergence profile and contour configuration have been associated with peri-implant biologic complications, limited evidence is available regarding the biologic influence of different buccal contour zones above the implant platform, particularly within the esthetic region. Existing studies have mainly focused on interproximal restorative contours, while the influence of buccal contour configuration at different vertical levels on peri-implant hard and soft tissue conditions remains unclear.

This study will retrospectively analyze patients restored with screw-retained or screwmentable implant-supported prostheses with customized abutments and at least 1 year of follow-up after prosthetic loading. Clinical records, intraoral photographs, radiographic images, and cone-beam computed tomography (CBCT) scans obtained during routine implant treatment and maintenance will be reviewed.

The primary objective is to evaluate whether buccal prosthetic profile angles measured at different vertical supraplatform zones demonstrate different associations with peri-implant marginal bone level changes. Buccal contour-related angles will include the overall buccal emergence angle, the buccal profile angle measured within 0-2 mm above the implant platform, and the buccal profile angle measured within 2-4 mm above the implant platform. These measurements are intended to investigate whether different peri-implant tissue levels demonstrate different biologic responses to prosthetic contour configuration.

Secondary objectives include evaluation of the association between prosthetic contour variables and peri-implant soft tissue conditions, including keratinized mucosa width (KMW), mucosal margin changes, probing depth, bleeding on probing, mucosal tunnel depth, and peri-implant soft tissue thickness. Additional peri-implant phenotype-related variables, including buccal bone thickness, implant placement depth, and soft tissue augmentation procedures, will also be analyzed for their potential association with peri-implant tissue remodeling.

Marginal bone level changes and peri-implant tissue conditions will be evaluated using clinical measurements, standardized intraoral photographs, vertical bitewing radiographs, and CBCT images obtained during routine follow-up care. CBCT analysis will be performed at 1 year after prosthetic loading to evaluate three-dimensional peri-implant bone morphology and prosthetic contour configuration.

Statistical analyses will include descriptive statistics and normality assessment. Depending on data distribution, Mann-Whitney U tests or Kruskal-Wallis tests may be used for supportive group comparisons when appropriate. Associations between peri-implant tissue changes and prosthetic contour variables will primarily be evaluated using univariable and multivariable linear regression analyses. Interaction analyses will also be performed to evaluate whether peri-implant phenotype-related variables modify the association between prosthetic contour angles and marginal bone level changes. Segmented regression analysis will additionally be performed to explore potential threshold effects associated with peri-implant tissue remodeling. All statistical tests will be two-sided with a significance level of α = 0.05.

The planned sample size is approximately 100 implant sites with complete clinical and radiographic follow-up records. Only cases with complete imaging quality and adequate follow-up documentation will be included in the final analysis. Missing or incomplete records, radiographic artifacts, severe image distortion, or inadequate maintenance follow-up will lead to exclusion from analysis.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾
        • Chang Gung Memorial Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients receiving bone-level dental implant treatment with customized abutments and screw-retained or screwmentable prosthetic restorations at Chang Gung Memorial Hospital will be retrospectively included. Eligible participants will have completed two-stage implant surgery, prosthetic rehabilitation, and routine maintenance follow-up with available clinical records, intraoral photographs, radiographic examinations, and cone-beam computed tomography (CBCT) scans for at least 1 year after prosthetic loading. Implant placement, peri-implant soft tissue management, and follow-up procedures were performed under standardized clinical protocols by the same experienced clinician to minimize procedural variability. Patients with inadequate imaging quality, incomplete follow-up records, peri-implant bone dehiscence after implant placement, or systemic conditions affecting healing will be excluded.

描述

Inclusion Criteria:

  • Adults aged 20 years or older.
  • Patients receiving at least one bone-level dental implant restored with a customized abutment and screw-retained or screwmentable prosthesis.
  • Presence of at least one adjacent natural tooth and an opposing dentition.
  • Implant sites that received second-stage surgery and prosthetic restoration.
  • Presence of at least 2 mm of peri-implant keratinized mucosa after second-stage surgery.
  • No buccal or peri-implant bone dehiscence following implant placement.
  • Availability of complete clinical records, intraoral photographs, radiographic images, and cone-beam computed tomography (CBCT) scans with at least 1 year of follow-up after prosthetic loading.

Availability of adequate radiographic quality for peri-implant hard and soft tissue measurements.

Exclusion Criteria:

  • Uncontrolled systemic diseases or medical conditions that may affect healing, including uncontrolled diabetes mellitus, metabolic bone diseases, autoimmune diseases, or history of head and neck radiotherapy.
  • Current use of medications known to affect bone metabolism.
  • Pregnancy, planned pregnancy, or breastfeeding.
  • Poor-quality CBCT images or radiographic artifacts that interfere with measurement accuracy.
  • Incomplete clinical or radiographic follow-up records.
  • Poor oral hygiene or irregular supportive maintenance follow-up.
  • Implant sites with prosthetic or imaging conditions preventing reliable evaluation of prosthetic contour configuration or peri-implant tissue measurements.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Bone-Level Implant Cohort
Participants receiving bone-level dental implants restored with customized abutments and screw-retained or screwmentable prostheses with available longitudinal clinical and radiographic follow-up data for at least 1 year after prosthetic loading. Clinical records, intraoral photographs, vertical bitewing radiographs, and cone-beam computed tomography (CBCT) scans obtained during routine implant treatment and maintenance care will be retrospectively analyzed to evaluate the association between buccal prosthetic profile angles at different supraplatform zones and peri-implant hard and soft tissue remodeling. Peri-implant phenotype-related variables, including mucosal tunnel depth, soft tissue thickness, keratinized mucosa width, and buccal bone thickness, will also be evaluated.
Participants included in this retrospective observational cohort study received routine implant-supported prosthetic rehabilitation with bone-level dental implants restored using customized abutments and screw-retained or screwmentable prostheses. Prosthetic contour configuration and buccal profile angles at different supraplatform vertical zones (overall emergence angle, 0-2 mm profile angle, and 2-4 mm profile angle above the implant platform) will be evaluated using cone-beam computed tomography (CBCT) and radiographic analysis. Clinical and radiographic follow-up data obtained during routine maintenance care up to 1 year after prosthetic loading will be retrospectively analyzed to assess associations between prosthetic contour characteristics and peri-implant hard and soft tissue remodeling.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Marginal Bone Level Change
大体时间:Baseline(implant placement) to 1 year after prosthetic loading
Change in peri-implant marginal bone level associated with buccal prosthetic profile angles measured at different supraplatform vertical zones (overall emergence angle, 0-2 mm profile angle, and 2-4 mm profile angle above the implant platform), evaluated using radiographic and cone-beam computed tomography (CBCT) analysis.
Baseline(implant placement) to 1 year after prosthetic loading

次要结果测量

结果测量
措施说明
大体时间
Keratinized Mucosa Width (KMW) Change
大体时间:Baseline to 1 year after prosthetic loading
Change in peri-implant keratinized mucosa width associated with buccal prosthetic profile angles at different supraplatform vertical zones.
Baseline to 1 year after prosthetic loading
Buccal Bone Thickness
大体时间:1 year after prosthetic loading
Buccal peri-implant bone thickness evaluated on CBCT images at 1 year after prosthetic loading.
1 year after prosthetic loading
Mucosal Tunnel Depth
大体时间:Baseline (at prosthetic loading)
Clinical mucosal tunnel depth associated with prosthetic contour configuration and peri-implant tissue remodeling.
Baseline (at prosthetic loading)
Probing depth change
大体时间:Baseline to 1 year after prosthetic loading
Change in peri-implant probing depth associated with buccal prosthetic profile angle.
Baseline to 1 year after prosthetic loading

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Cho-Ying Lin、Chang Gung Memorial Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年11月13日

初级完成 (实际的)

2025年10月16日

研究完成 (估计的)

2026年7月31日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be publicly available because of privacy and institutional data protection restrictions.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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