NCT07637864

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

June 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5.9 years

First QC Date

May 21, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

Dental ImplantsProsthetic ContourProfile AnglePeri-Implant Bone RemodelingMarginal Bone Lossuccal Bone ThicknessEmergence angleCone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Level Change

    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

Secondary Outcomes (4)

  • Keratinized Mucosa Width (KMW) Change

    Baseline to 1 year after prosthetic loading

  • Buccal Bone Thickness

    1 year after prosthetic loading

  • Mucosal Tunnel Depth

    Baseline (at prosthetic loading)

  • Probing depth change

    Baseline to 1 year after prosthetic loading

Study Arms (1)

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.

Procedure: Implant-Supported Prosthetic Restoration

Interventions

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.

Bone-Level Implant Cohort

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Related Publications (8)

  • 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.

    PMID: 39799344BACKGROUND
  • 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.

    PMID: 37461128BACKGROUND
  • 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.

    PMID: 35817419BACKGROUND
  • 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.

    PMID: 39385502BACKGROUND
  • 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.

    PMID: 35661355BACKGROUND
  • 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.

    PMID: 24673875BACKGROUND
  • 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.

    PMID: 39927705BACKGROUND
  • 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.

    PMID: 38129258BACKGROUND

Study Officials

  • Cho-Ying Lin

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 10, 2026

Study Start

November 13, 2019

Primary Completion

October 16, 2025

Study Completion

July 31, 2026

Last Updated

June 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations