Research on the Development and Clinical Evaluation of Biomimetic Abutments

Last updated: March 6, 2025
Sponsor: Stomatological Hospital Affiliated with Fujian Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

using biomimetic abutments

Clinical Study ID

NCT06870955
20211212
  • Ages 25-65
  • All Genders

Study Summary

This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged between 25 and 65 years old

  • had one single edentulous site

  • implant embedded healed and required secondary surgery to expose

  • good treatment compliance and could attend follow-up appointment regularly

Exclusion

Exclusion Criteria:

  • soft tissue grafting was needed

  • severe acute or chronic periodontitis

  • heavy smoking habit (> 10 cigarettes/day)

  • poor oral hygiene

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: using biomimetic abutments
Phase:
Study Start date:
November 23, 2023
Estimated Completion Date:
September 30, 2025

Study Description

The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.

To assess soft tissues, digital models were collected in STL files at five time points: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration. These models were analyzed using 3D software for model matching and measurement based on CBCT, focusing on the changes on soft tissue height, width, and volume.

Hard tissue evaluation was conducted through periapical radiographs taken at three time points: immediately after restoration, six months after restoration, and 12 months after restoration.

Additionally, general clinical conditions were assessed at the same three time points, evaluating parameters such as food impaction, plaque index, and gingival index.

Connect with a study center

  • The Affiliated Stomatological Hospital of Fujian Medical University

    Fuzhou, Fujian 350002
    China

    Active - Recruiting

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