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Buccal Prosthetic Contour Angles and Peri-Implant Tissue Changes Around Dental Implants

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07637864
Acronym
B-PROFILE
Enrollment
100
Registered
2026-06-10
Start date
2019-11-13
Completion date
2026-07-31
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Early Peri-Implant Bone Remodeling, Peri-Implant Soft Tissue Remodeling

Keywords

Dental Implants, Prosthetic Contour, Profile Angle, Peri-Implant Bone Remodeling, Marginal Bone Loss, uccal Bone Thickness, Emergence angle, Cone-Beam Computed Tomography

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREImplant-Supported Prosthetic Restoration

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Marginal Bone Level ChangeBaseline(implant placement) to 1 year after prosthetic loadingChange 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.

Secondary

MeasureTime frameDescription
Keratinized Mucosa Width (KMW) ChangeBaseline to 1 year after prosthetic loadingChange in peri-implant keratinized mucosa width associated with buccal prosthetic profile angles at different supraplatform vertical zones.
Buccal Bone Thickness1 year after prosthetic loadingBuccal peri-implant bone thickness evaluated on CBCT images at 1 year after prosthetic loading.
Mucosal Tunnel DepthBaseline (at prosthetic loading)Clinical mucosal tunnel depth associated with prosthetic contour configuration and peri-implant tissue remodeling.
Probing depth changeBaseline to 1 year after prosthetic loadingChange in peri-implant probing depth associated with buccal prosthetic profile angle.

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORCho-Ying Lin

Chang Gung Memorial Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026