- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514585
Feasibility Study on the Application of Bionic Healing Abutments in Implant Impressions
April 1, 2026 updated by: Cheng Hui, Fujian Medical University
The bionic healing abutment of the group's previous research results has both soft tissue shaping and impression taking functions, realizing the advantages of no need to dismantle the impression, simplifying clinical operation, maintaining soft tissue closure and reducing patient discomfort, responding to the requirements of the new quality productivity.
On this basis, this study is intended to explore the accuracy of implant restorative impressions with bionic healing abutment and transfer bar in the impression of membrane material, and with bionic healing abutment and scanning bar in the digital impression in the case of different parts of the missing teeth and different numbers of missing teeth, so as to provide a basis for the application of bionic healing abutment in implant restorative impressions and guidance on the use of the clinic.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
8
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
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Fujian
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Fuzhou, Fujian, China, 350025
- The Affiliated Stomatological Hospital of Fujian Medical University
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients attending Fujian Medical University Stomatological Hospital
Description
Inclusion Criteria:
- The patient had good oral hygiene, no visible calculus on the gingival margins, and good periodontal condition
- Age 18-65 years, good general condition, no serious underlying disease, can tolerate multiple molding operations
- Specific missing teeth with no serious soft or hard tissue lesions in the missing area, no bad biting habits, and no obvious tilting, shifting or loosening of the remaining teeth.
Exclusion Criteria:
- Tilting, shifting, loosening of remaining teeth
- Non-specific tooth loss
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
Cohorts and Interventions
Group / Cohort |
|---|
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Unilateral loss of maxillary first molar
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Bilateral loss of maxillary first molars
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Bilateral loss of maxillary first and second molars
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Unilateral loss of maxillary first and second molars
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Bilateral loss of maxillary first premolar, second premolar,first molar
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Unilateral loss of maxillary first premolar, second premolar,first molar
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Bilateral loss of maxillary first premolar, second premolar,first molar,second molar
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Unilateral loss of maxillary first premolar, second premolar,first molar,second molar
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Angular deviation
Time Frame: 3 year
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The digital data of the model is imported into the relevant software for implant matching, dentition segmentation, and processing of associated areas.
In the reverse engineering software Geomagic Control X, the corresponding regions are aligned, the crown axis inclination of the implants is measured, and the angle between each crown axis and the implant axis is calculated, which represents the angular deviation.
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3 year
|
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Distance deviation
Time Frame: 3 year
|
The digital data of the model is imported into the relevant software for implant matching, dentition segmentation, and processing of associated areas.
In the reverse engineering software Geomagic Control X, the corresponding regions are aligned, the apex of each implant in the digital model is identified, and the distances between the implants are calculated, which represents the distance deviation.
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
November 26, 2024
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2024Clin005
- Clin005 (Other Identifier: Fujian Medical University Affiliated Stomatological Hospital)
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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