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

4 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

100

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Taipei, Taiwan
        • Chang Gung Memorial Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Marginal Bone Level Change
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Keratinized Mucosa Width (KMW) Change
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Cho-Ying Lin, Chang Gung Memorial Hospital

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de novembro de 2019

Conclusão Primária (Real)

16 de outubro de 2025

Conclusão do estudo (Estimado)

31 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de fevereiro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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