Research on the Development and Clinical Evaluation of Biomimetic Abutments
NCT ID: NCT06870955
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-11-23
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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biomimetic abutment group
The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
Historical or external data from other sources were used as controls to evaluate the treatment efficacy in the experimental group.
using biomimetic abutments
The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
Interventions
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using biomimetic abutments
The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* severe acute or chronic periodontitis
* heavy smoking habit (\> 10 cigarettes/day)
* poor oral hygiene
25 Years
65 Years
ALL
No
Sponsors
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Stomatological Hospital Affiliated with Fujian Medical University
OTHER
Responsible Party
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Cheng Hui
Professor of Prosthodontics
Principal Investigators
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Hui Cheng, PhD
Role: PRINCIPAL_INVESTIGATOR
Stomatological Hospital Affiliated with Fujian Medical University
Locations
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The Affiliated Stomatological Hospital of Fujian Medical University
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20211212
Identifier Type: -
Identifier Source: org_study_id
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