Research on the Development and Clinical Evaluation of Biomimetic Abutments

NCT ID: NCT06870955

Last Updated: 2025-03-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Tooth Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

using biomimetic abutments

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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 Criteria

* soft tissue grafting was needed
* severe acute or chronic periodontitis
* heavy smoking habit (\> 10 cigarettes/day)
* poor oral hygiene
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stomatological Hospital Affiliated with Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Cheng Hui

Professor of Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Hui Cheng, PhD

Role: CONTACT

18960883888

Facility Contacts

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Hui Cheng, PhD

Role: primary

18960883888

Other Identifiers

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20211212

Identifier Type: -

Identifier Source: org_study_id

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