Ten Year Follow up of Convergent Profile Implants

July 20, 2025 updated by: Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari

Ten-Year Follow-Up Analysis of MBL and PES Outcomes Around Convergent Transmucosal Profile Implants

The aim of the study is to evaluate the marginal bone level (MBL) and pink aesthetic score (PES) changes on the short, medium and long-term, on a retrospective cohort of patients who received at least one "biotype implant" (DEI ITALIA SRL, Mercallo VA, Italy) with convergent transmucosal profile. Ninety-seven patients with at least one periapical x-ray taken on the day of implant placement and at least one taken in the following 10 years were included for MBL analysis and 90 patients who had at least one photograph taken on the day of implant loading, and one taken in the following 10 years for PES analysis. The radiographs were divided into 4 groups: (1) implant placement; (2) 1-2 years follow-up (short-term); (3) 3-6 years follow-up (medium-term); (4) ≥7 years follow-up (long-term). Photographs were grouped similarly, except that the first group was relative to the day of prosthetic loading. MBL was measured using ImageJ software. Results were analyzed with Generalized Estimating Equations method using SPSS software, the P value was set at <0.05 for significance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Modern implantology has evolved over the past decades toward solutions that optimize not only the **functional stability** of implants but also the **aesthetic outcome** and the preservation of **hard and soft tissues**. One such innovation is the *convergent transmucosal profile*, a design configuration for dental implants aimed at promoting the coronal migration of collagen fibers, reducing **marginal bone loss (MBL)**, and improving the stability of soft tissues.

**Marginal Bone Loss (MBL)** is a key parameter in assessing the long-term stability of implants and is measured as a reduction in the height of the marginal bone around the implant. The **Pink Esthetic Score (PES)**, on the other hand, qualitatively evaluates the aesthetic outcome of the peri-implant soft tissues by considering parameters such as the shape and fullness of the papilla, the contour of the soft tissues, and the color of the mucosa in relation to the prosthesis.

This **retrospective study** aims to evaluate, in a cohort of patients, the effectiveness of the convergent transmucosal profile of dental implants with respect to bone stability and aesthetic outcomes.

**Study Aim** The main objective of the study is to analyze the **long-term stability** of Marginal Bone Level (MBL) and the Pink Esthetic Score (PES) in a retrospective cohort of patients treated with implants featuring a convergent transmucosal profile. The study intends to identify correlations between aesthetic parameters and bone stability, also evaluating the clinical implications of this implant design.

**Materials and Methods**

**Study Design** The study will be retrospective, based on the analysis of medical records and radiographic data collected in a standardized manner. Selected patients received at least one implant with a convergent transmucosal profile and were followed for **at least 10 years**.

**Inclusion Criteria**

  • Adult patients aged between 18 and 75 years.
  • Presence of at least one periapical radiograph taken at the time of implant placement and another at 1-2 years, 3-6 years, and 7-10 years after insertion.
  • Photographic documentation for PES assessments performed at prosthetic loading and during follow-ups.

**Exclusion Criteria**

  • Patients with uncompensated systemic diseases (uncontrolled diabetes, severe autoimmune diseases).
  • Heavy smokers (>10 cigarettes per day).
  • Incomplete clinical and radiographic documentation.

**Description of the Convergent Transmucosal Profile** The convergent transmucosal profile is characterized by a design that reduces the bulk of the implant neck near the soft tissues. This configuration promotes the coronal migration of collagen fibers, creating a biological seal that helps preserve the bone margin and support the soft tissues, thereby improving aesthetic outcomes.

**Data Collection**

  1. **MBL Measurement:** Marginal Bone Loss will be measured using standardized periapical radiographs, with dedicated software such as ImageJ, assessing the distance between the edge of the implant platform and the first bone contact.
  2. **PES Evaluation:** The Pink Esthetic Score will be calculated by analyzing photographic images, considering parameters such as the fullness and shape of the papillae, the contour of the soft tissues, mucosal color, and the overall aesthetic integration.

**Sample Size Calculation** The sample size was calculated assuming a clinically relevant difference of 0.5 mm in MBL with a standard deviation of 0.3 mm. With a significance level of 5% and a power of 80%, at least 45 subjects are required. To account for possible dropouts during follow-up, the sample will be increased by 20%, bringing the minimum number to 54 patients.

**Statistical Analysis** Data will be analyzed using SPSS software. Continuous variables will be expressed as means and standard deviations. The data analysis will be conducted using Generalized Estimating Equations (GEE) to manage the dependence between repeated measurements over time. The correlation between MBL and PES will be assessed using the Pearson coefficient. A p-value less than 0.05 will be considered significant.

**Ethical Considerations** The study will be conducted in accordance with the Declaration of Helsinki. All clinical and radiographic data will be anonymized to ensure patient privacy. No additional interventions are planned, and the study does not pose risks to participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cagliari, Italy, 09042
        • Cagliari University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who received at least one implant with transmucosal convergent profile

Description

Inclusion Criteria:

  • Adult patients aged between 18 and 75 years.
  • Presence of at least one periapical radiograph taken at the time of implant placement and another at 1-2 years, 3-6 years, and 7-10 years after insertion.
  • Photographic documentation for PES assessments performed at prosthetic loading and during follow-ups.

Exclusion Criteria:

  • Patients with uncompensated systemic diseases (uncontrolled diabetes, severe autoimmune diseases).
  • Heavy smokers (>10 cigarettes per day).
  • Incomplete clinical and radiographic documentation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Marginal bone level
Time Frame: 1 to 10 years after implant placement compared to baseline
The level of the peri-implant marginal bone measured on intraoral radiograph at various time points
1 to 10 years after implant placement compared to baseline
Pink Esthetic Score
Time Frame: from baseline (implant placement) to 10 years
A scoring system that evaluates the esthetic appearance of soft tissue around dental implants based on five parameters-mesial papilla, distal papilla, curvature and level of facial mucosa, and root convexity/soft-tissue color and texture-each scored from 0 to 2, for a maximum of 10 points
from baseline (implant placement) to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Biotype retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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