Ten Year Follow up of Convergent Profile Implants

NCT07089407 | Completed DMC

• 1 other identifier: Biotype retro
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Bone Loss; Peri-Implant Tissues

Keywords

Implants; Transmucosal profile; Marginal bone loss; Pink esthetic score

Outcome Measures

Primary Outcomes (2)

• Marginal bone level

  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

  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

Interventions

Dental implant placement DEVICE

Implant site prepared through a consecutive drilling procedure in the maxilla or the mandible, implant placed.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received at least one implant with transmucosal convergent profile

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Cagliari University Hospital

Cagliari, Cagliari, 09042, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)