Tooth LossNCT06870955
Research on the Development and Clinical Evaluation of Biomimetic Abutments
A study testing using biomimetic abutments in people with Tooth Loss, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site in China.
Trial summary
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- using biomimetic abutments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 30 Sep 2025
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- soft tissue grafting was needed
- severe acute or chronic periodontitis
- heavy smoking habit (> 10 cigarettes/day)
- poor oral hygiene
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, 1 recruiting
- Recruiting
The Affiliated Stomatological Hospital of Fujian Medical University
Fuzhou, Fujian, 350002
Hui Cheng, PhD, 18960883888, ch_fujian@163.com
About this study
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
Read the detailed 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.
- Conditions
- Tooth Loss
- Being tested
- using biomimetic abutments
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using biomimetic abutmentsProcedure or surgery
The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
| Study group | Role | What they receive |
|---|---|---|
| biomimetic abutment group | Experimental | 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. Receives: Procedure: using biomimetic abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in soft tissue contour
Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages.
Measured: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration
Secondary outcomes (4)
Changes in hard tissue contour
Changes of hard tissue contour in height through periapical radiographs using a long-cone paralleling technique with a film holder.
Measured: immediately after restoration, six months after restoration, and 12 months after restoration
Food impaction
Incidence of food impaction： Dichotomous registration, 0 = Absent; 1 = Present.
Measured: immediately after restoration, six months after restoration, and 12 months after restoration
Plaque index
0 = No plaque at the gingival margin; 1 = Thin plaque layer on the gingival margin, not easily visible on inspection but detectable by scraping with a probe; 2 = Moderate plaque accumulation at the gingival margin or interproximal surfaces; 3 = Heavy plaque accumulation in the gingival sulcus, at the gingival margin, or on interproximal surfaces. Mean values among the 6 sites were obtained (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).
Measured: immediately after restoration, six months after restoration, and 12 months after restoration
Gingival index
0 = Normal gingiva; 1 = Slight gingival edema, no bleeding on probing; 2 = Gingival edema with bleeding on probing; 3 =Tendency for spontaneous bleeding or presence of ulceration. Mean values among the 6 sites were obtained (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).
Measured: immediately after restoration, six months after restoration, and 12 months after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start23 Nov 2023
- Primary completion25 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Hui, Stomatological Hospital Affiliated with Fujian Medical University
- Investigators
- Hui Cheng, PhD, Principal investigator, Stomatological Hospital Affiliated with Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870955
- Sponsor's protocol ID
- 20211212
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Development and Clinical Evaluation of Biomimetic Abutments
- ClinicalTrials.gov ID
- NCT06870955
- Acronym / sponsor ID
- 20211212
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biomimetic abutment group | Experimental | Procedure: using biomimetic abutmentsThe 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- soft tissue grafting was needed
- severe acute or chronic periodontitis
- heavy smoking habit (> 10 cigarettes/day)
- poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| using biomimetic abutmentsThe subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration. | Procedure or surgery | biomimetic abutment group |
Primary outcome
Changes in soft tissue contour
Time frame: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration
Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages.
4 secondary outcomes
Changes in hard tissue contour
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Food impaction
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Plaque index
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Gingival index
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
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 11 Mar 2025.
- 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.
Hui Cheng, PhD principal investigator
Stomatological Hospital Affiliated with Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using biomimetic abutments in people with Tooth Loss, run by Stomatological Hospital Affiliated with 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. 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?
Contact Hui Cheng, PhD (18960883888, ch_fujian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in soft tissue contour (time frame: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration). 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 11 Mar 2025.