Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

4 juni 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Taipei, Taiwan
        • Chang Gung Memorial Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Marginal Bone Level Change
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Keratinized Mucosa Width (KMW) Change
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Cho-Ying Lin, Chang Gung Memorial Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 november 2019

Primärt slutförande (Faktisk)

16 oktober 2025

Avslutad studie (Beräknad)

31 juli 2026

Studieregistreringsdatum

Först inskickad

21 maj 2026

Först inskickad som uppfyllde QC-kriterierna

4 juni 2026

Första postat (Faktisk)

10 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 juni 2026

Senast verifierad

1 februari 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera