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

2026년 6월 4일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Taipei, 대만
        • Chang Gung Memorial Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Marginal Bone Level Change
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Keratinized Mucosa Width (KMW) Change
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Cho-Ying Lin, Chang Gung Memorial Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 11월 13일

기본 완료 (실제)

2025년 10월 16일

연구 완료 (추정된)

2026년 7월 31일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 2월 1일

추가 정보

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개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

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