Dentition DefectNCT07514585
Feasibility Study on the Application of Bionic Healing Abutments in Implant Impressions
An observational study of Dentition Defect and Healing Abutment, run by Fujian Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dentition Defect, Healing Abutment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending Fujian Medical University Stomatological Hospital
Who may be able to join
- 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.
Who cannot join
- Tilting, shifting, loosening of remaining teeth
- Non-specific tooth loss
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Stomatological Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
About this study
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.
- Conditions
- Dentition Defect, Healing Abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral loss of maxillary first molar | Not described | |
| Bilateral loss of maxillary first molars | Not described | |
| Bilateral loss of maxillary first and second molars | Not described | |
| Unilateral loss of maxillary first and second molars | Not described | |
| Bilateral loss of maxillary first premolar, second premolar，first molar | Not described | |
| Unilateral loss of maxillary first premolar, second premolar，first molar | Not described | |
| Bilateral loss of maxillary first premolar, second premolar，first molar，second molar | Not described | |
| Unilateral loss of maxillary first premolar, second premolar，first molar，second molar | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation
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.
Measured: 3 year
Distance deviation
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Dec 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentition DefectStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Hui, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514585
- Sponsor's protocol ID
- 2024Clin005
- Other IDs
- Clin005
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Application of Bionic Healing Abutments in Implant Impressions
- ClinicalTrials.gov ID
- NCT07514585
- Acronym / sponsor ID
- 2024Clin005
- Conditions
- Dentition Defect, Healing Abutment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Unilateral loss of maxillary first molar | – | – |
| Bilateral loss of maxillary first molars | – | – |
| Bilateral loss of maxillary first and second molars | – | – |
| Unilateral loss of maxillary first and second molars | – | – |
| Bilateral loss of maxillary first premolar, second premolar，first molar | – | – |
| Unilateral loss of maxillary first premolar, second premolar，first molar | – | – |
| Bilateral loss of maxillary first premolar, second premolar，first molar，second molar | – | – |
| Unilateral loss of maxillary first premolar, second premolar，first molar，second molar | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending Fujian Medical University Stomatological Hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Tilting, shifting, loosening of remaining teeth
- Non-specific tooth loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Angular 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 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentition Defect and Healing Abutment, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular deviation (time frame: 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.