- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07637864
Buccal Prosthetic Contour Angles and Peri-Implant Tissue Changes Around Dental Implants (B-PROFILE)
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan
- Chang Gung Memorial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Marginal Bone Level Change
Tidsramme: Baseline(implant placement) to 1 year after prosthetic loading
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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.
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Baseline(implant placement) to 1 year after prosthetic loading
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Keratinized Mucosa Width (KMW) Change
Tidsramme: Baseline to 1 year after prosthetic loading
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Change in peri-implant keratinized mucosa width associated with buccal prosthetic profile angles at different supraplatform vertical zones.
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Baseline to 1 year after prosthetic loading
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Buccal Bone Thickness
Tidsramme: 1 year after prosthetic loading
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Buccal peri-implant bone thickness evaluated on CBCT images at 1 year after prosthetic loading.
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1 year after prosthetic loading
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Mucosal Tunnel Depth
Tidsramme: Baseline (at prosthetic loading)
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Clinical mucosal tunnel depth associated with prosthetic contour configuration and peri-implant tissue remodeling.
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Baseline (at prosthetic loading)
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Probing depth change
Tidsramme: Baseline to 1 year after prosthetic loading
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Change in peri-implant probing depth associated with buccal prosthetic profile angle.
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Baseline to 1 year after prosthetic loading
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Cho-Ying Lin, Chang Gung Memorial Hospital
Publikationer og nyttige links
Generelle publikationer
- Linkevicius T, Puisys A, Steigmann M, Vindasiute E, Linkeviciene L. Influence of Vertical Soft Tissue Thickness on Crestal Bone Changes Around Implants with Platform Switching: A Comparative Clinical Study. Clin Implant Dent Relat Res. 2015 Dec;17(6):1228-36. doi: 10.1111/cid.12222. Epub 2014 Mar 28.
- Tang Y, Wang J, Qiu L, Yu H. Influence of buccal mucosa width/height ratio, emergence profile and buccal bone width on peri-implant tissues: a prospective one-year study. BMC Oral Health. 2025 Jan 11;25(1):61. doi: 10.1186/s12903-025-05426-3.
- Pelekos G, Chin B, Wu X, Fok MR, Shi J, Tonetti MS. Association of crown emergence angle and profile with dental plaque and inflammation at dental implants. Clin Oral Implants Res. 2023 Oct;34(10):1047-1057. doi: 10.1111/clr.14134. Epub 2023 Jul 17.
- Siegenthaler M, Strauss FJ, Gamper F, Hammerle CHF, Jung RE, Thoma DS. Anterior implant restorations with a convex emergence profile increase the frequency of recession: 12-month results of a randomized controlled clinical trial. J Clin Periodontol. 2022 Nov;49(11):1145-1157. doi: 10.1111/jcpe.13696. Epub 2022 Aug 10.
- Strauss FJ, Park JY, Lee JS, Schiavon L, Smirani R, Hitz S, Chantler JGM, Mattheos N, Jung R, Bosshardt D, Cha JK, Thoma D. Wide Restorative Emergence Angle Increases Marginal Bone Loss and Impairs Integrity of the Junctional Epithelium of the Implant Supracrestal Complex: A Preclinical Study. J Clin Periodontol. 2024 Dec;51(12):1677-1687. doi: 10.1111/jcpe.14070. Epub 2024 Oct 9.
- Lin CY, Kuo PY, Chiu MY, Wang HL. Depth of mucosal tunnel in peri-implant health during 12-month follow-up in patients with controlled periodontitis. J Periodontol. 2023 Jan;94(1):66-76. doi: 10.1002/JPER.21-0680. Epub 2022 Jul 1.
- Misch J, Abu-Reyal S, Lohana D, Mandil O, Saleh MHA, Li J, Wang HL, Ravida A. Combined Effect of Abutment Height and Restoration Emergence Angle on Peri-Implant Bone Loss Progression: A Retrospective Analysis. Clin Oral Implants Res. 2025 May;36(5):600-612. doi: 10.1111/clr.14408. Epub 2025 Feb 10.
- Han JW, Han JW, Pyo SW, Kim S. Impact of profile angle of CAD-CAM abutment on the marginal bone loss of implant-supported single-tooth posterior restorations. J Prosthet Dent. 2025 Oct;134(4):1180-1186. doi: 10.1016/j.prosdent.2023.11.025. Epub 2023 Dec 21.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 202600203B0
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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