AzTrials
AzTrials

Dental ImplantsB-PROFILENCT07637864

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

An observational study of Dental Implants and Early Peri-Implant Bone Remodeling, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Implant-Supported Prosthetic Restoration
Type of treatment
Surgery or procedure
How many people
72 participants
Where
1 siteTaiwan
Study dates
13 Nov 2019to 31 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung Memorial Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read more

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant-Supported Prosthetic RestorationProcedure or surgery

    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.

Study groups in NCT07637864
Study groupRoleWhat they receive
Bone-Level Implant CohortParticipants 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.
Receives: Procedure: Implant-Supported Prosthetic Restoration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline(implant placement) to 1 year after prosthetic loading

Secondary outcomes (4)
  1. Keratinized Mucosa Width (KMW) Change

    Change in peri-implant keratinized mucosa width associated with buccal prosthetic profile angles at different supraplatform vertical zones.

    Measured: Baseline to 1 year after prosthetic loading

  2. Buccal Bone Thickness

    Buccal peri-implant bone thickness evaluated on CBCT images at 1 year after prosthetic loading.

    Measured: 1 year after prosthetic loading

  3. Mucosal Tunnel Depth

    Clinical mucosal tunnel depth associated with prosthetic contour configuration and peri-implant tissue remodeling.

    Measured: Baseline (at prosthetic loading)

  4. Probing depth change

    Change in peri-implant probing depth associated with buccal prosthetic profile angle.

    Measured: Baseline to 1 year after prosthetic loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start13 Nov 2019
  3. Primary completion16 Oct 2025
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637864
Sponsor's protocol ID
202600203B0
Acronym
B-PROFILE
Status last verified
Feb 2026
First submitted
21 May 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly available because of privacy and institutional data protection restrictions.

Publications

  • 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.

    PubMed 39799344
  • 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.

    PubMed 37461128
  • 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.

    PubMed 35817419
  • 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.

    PubMed 39385502
  • 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.

    PubMed 35661355
  • 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.

    PubMed 24673875
  • 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.

    PubMed 39927705
  • 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.

    PubMed 38129258

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Implants and Early Peri-Implant Bone Remodeling, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Marginal Bone Level Change (time frame: Baseline(implant placement) to 1 year after prosthetic loading). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07637864, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in