Site PreservationNCT07334067
Site Preservation Was Performed Through an Open Healing Oral Restorative Membrane
A study testing site preservation surgery with open healing and site preservation surgery with close sutures in people with Site Preservation and Soft Tissue Healing, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
In this study, an open healing oral restoration membrane was used for site preservation in the esthetic area after tooth extraction to maintain the space for tooth extraction and bone formation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Site Preservation, Soft Tissue Healing, Anterior Dental Aesthetic Area
- What is being tested?
- site preservation surgery with open healing and site preservation surgery with close sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 30 Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1: Age ≥18 years old
- 2: The affected teeth did not have the conditions for immediate implant placement: thin gingival biotype, labial bone plate thickness <1 mm, the labial bone plate was missing, the distance between the labial bone plate crest and the cemento-enamel junction>3 mm
- 3: No systemic diseases and good oral hygiene
- 4: Be willing to receive treatment and regular follow-up and review, and signed the informed consent
Who cannot join
- 1: Uncontrolled systemic diseases, such as heart, liver and kidney diseases, systemic infections, diabetes, etc
- 2: Women who are pregnant or lactating
- 3: Taking bisphosphonates, glucocorticoids and other drugs that affect bone metabolism for a long time or within 5 years
- 4: Patients receiving oral and maxillofacial radiotherapy in the past five years
- 5: Patients suffering uncontrolled periodontal disease
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
Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jue Shi, Doctor, +86 13757171359, dentistsj@zju.edu.cn
About this study
Official title: The Application and Efficacy of Dental Prosthesis Membrane in the Preservation of Anterior Esthetic Area After Tooth Extraction
In this study, an open healing oral restoration membrane was used for site preservation in the esthetic area after tooth extraction to maintain the space for tooth extraction and bone formation. Clinical observation and cone-beam computed tomography (CBCT) were used to comprehensively evaluate the effect of this operation on promoting the growth of soft and hard tissues, and to provide a new treatment method for site preservation in the esthetic area of clinical anterior teeth.
Read the detailed description
The anterior tooth region is the key area of aesthetics, which has always been the difficulty and hotspot of implant restoration. In tooth extraction caused by various diseases, the amount of new bone in the tooth extraction fossa often cannot reach the level of the original alveolar ridge, especially the damage to the lip and buccal bone plate is more serious, resulting in insufficient bone mass when the implant is implanted in the later stage. Therefore, bone increment surgery is often used to reconstruct the collapsed alveolar ridge. Among them, site preservation has been widely adopted because of its effective promotion of autologous bone regeneration, simple operation and strong operability. Site preservation is performed by bone grafting on the extraction fossa immediately after tooth extraction to preserve the height and width of the remaining alveolar ridge as much as possible, and retain the corresponding amount of soft tissue, so as to provide sufficient bone mass for later implantation surgery and repair, so as to obtain good aesthetic repair effects.
However, there is currently a lack of oral biofilm that can be opened for healing. After filling bone meal and covering barrier biofilm, the mucosal tissue needs to be fully reduced and then tightly sutured. Sufficient reduction of gingival soft tissue in the aesthetic area of the anterior teeth will undoubtedly increase the surgical wound, and obvious scars will appear in the early stage of repair, seriously affecting the aesthetic appearance. Therefore, in order to simplify the surgical plan of site preservation, reduce trauma, and obtain stable bone growth and good soft tissue morphology, this project proposed to use oral repair membrane with open healing to replace the commonly used clinical collagen membrane for site preservation of the aesthetic area of the anterior teeth.
In this study, an open healing oral restoration membrane was used for site preservation in the esthetic area after tooth extraction to maintain the space for tooth extraction and bone formation. Clinical observation and cone-beam computed tomography (CBCT) were used to comprehensively evaluate the effect of this operation on promoting the growth of soft and hard tissues, and to provide a new treatment method for site preservation in the esthetic area of clinical anterior teeth.
- Being tested
- site preservation surgery with open healing, site preservation surgery with close sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
site preservation surgery with open healingProcedure or surgery
Tooth extraction in the aesthetic area of the anterior teeth without the expansion and flap were reduced in the operative area. Site preservation surgery was perfomed using Bio-oss (0.5g, Small granule) and Yinlife PCL membrane (25*25mm size) , with opened wound.
site preservation surgery with close suturesProcedure or surgery
Tooth extraction in the aesthetic area of the anterior teeth with the expansion and flap were reduced in the operative area. Site preservation surgery was performed using Bio-oss (0.5g, Small granule) and bio-gide (25*25mm size) . The gums were closely drawn and sutured.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Tooth extraction in the aesthetic area of the anterior teeth with the expansion and flap were reduced in the operative area. Site preservation surgery was performed using Bio-oss (0.5g, Small granule) and bio-gide (25*25mm size) . The gums were closely drawn and sutured. Receives: Procedure: site preservation surgery with close sutures |
| Experimental group | Experimental | Tooth extraction in the aesthetic area of the anterior teeth without the expansion and flap were reduced in the operative area. Site preservation surgery was perfomed using Bio-oss (0.5g, Small granule) and Yinlife PCL membrane (25*25mm size) , with opened wound. Receives: Procedure: site preservation surgery with open healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue healing efficiency
After calibrating the magnification ratio of the tooth extraction wound photos, the reduction ratio of the tooth extraction wound area at 7 days, 14 days, 1 month, and 3 months after surgery was calculated based on the immediate postoperative tooth extraction wound photos to evaluate the soft tissue healing efficiency.
Measured: Immediately after surgery, 7 days, 14 days and 1 month after surgery
Secondary outcomes (1)
Bone healing efficiency
NNT Viewer software was used to calibrate CBCT images before and 3 months after surgery. The same section position was used to extract anterior teeth. The area marked by periodontal ligament outside the root before surgery was used as the extraction socket area, and the black corresponding to the blank in the postoperative image was used to represent the unhealed extraction socket. It was used to evaluate the healing efficiency of bone tissue.
Measured: Preoperative and postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Site PreservationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334067
- Sponsor's protocol ID
- 2024-093（R）
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application and Efficacy of Dental Prosthesis Membrane in the Preservation of Anterior Esthetic Area After Tooth Extraction
- ClinicalTrials.gov ID
- NCT07334067
- Acronym / sponsor ID
- 2024-093（R）
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jan 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.
In this study, an open healing oral restoration membrane was used for site preservation in the esthetic area after tooth extraction to maintain the space for tooth extraction and bone formation. Clinical observation and cone-beam computed tomography (CBCT) were used to comprehensively evaluate the effect of this operation on promoting the growth of soft and hard tissues, and to provide a new treatment method for site preservation in the esthetic area of clinical anterior teeth.
Detailed description
The anterior tooth region is the key area of aesthetics, which has always been the difficulty and hotspot of implant restoration. In tooth extraction caused by various diseases, the amount of new bone in the tooth extraction fossa often cannot reach the level of the original alveolar ridge, especially the damage to the lip and buccal bone plate is more serious, resulting in insufficient bone mass when the implant is implanted in the later stage. Therefore, bone increment surgery is often used to reconstruct the collapsed alveolar ridge. Among them, site preservation has been widely adopted because of its effective promotion of autologous bone regeneration, simple operation and strong operability. Site preservation is performed by bone grafting on the extraction fossa immediately after tooth extraction to preserve the height and width of the remaining alveolar ridge as much as possible, and retain the corresponding amount of soft tissue, so as to provide sufficient bone mass for later implantation surgery and repair, so as to obtain good aesthetic repair effects.
However, there is currently a lack of oral biofilm that can be opened for healing. After filling bone meal and covering barrier biofilm, the mucosal tissue needs to be fully reduced and then tightly sutured. Sufficient reduction of gingival soft tissue in the aesthetic area of the anterior teeth will undoubtedly increase the surgical wound, and obvious scars will appear in the early stage of repair, seriously affecting the aesthetic appearance. Therefore, in order to simplify the surgical plan of site preservation, reduce trauma, and obtain stable bone growth and good soft tissue morphology, this project proposed to use oral repair membrane with open healing to replace the commonly used clinical collagen membrane for site preservation of the aesthetic area of the anterior teeth.
In this study, an open healing oral restoration membrane was used for site preservation in the esthetic area after tooth extraction to maintain the space for tooth extraction and bone formation. Clinical observation and cone-beam computed tomography (CBCT) were used to comprehensively evaluate the effect of this operation on promoting the growth of soft and hard tissues, and to provide a new treatment method for site preservation in the esthetic area of clinical anterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: site preservation surgery with close suturesTooth extraction in the aesthetic area of the anterior teeth with the expansion and flap were reduced in the operative area. Site preservation surgery was performed using Bio-oss (0.5g, Small granule) and bio-gide (25*25mm size) . The gums were closely drawn and sutured. |
| Experimental group | Experimental | Procedure: site preservation surgery with open healingTooth extraction in the aesthetic area of the anterior teeth without the expansion and flap were reduced in the operative area. Site preservation surgery was perfomed using Bio-oss (0.5g, Small granule) and Yinlife PCL membrane (25*25mm size) , with opened wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1: Age ≥18 years old
- 2: The affected teeth did not have the conditions for immediate implant placement: thin gingival biotype, labial bone plate thickness <1 mm, the labial bone plate was missing, the distance between the labial bone plate crest and the cemento-enamel junction>3 mm
- 3: No systemic diseases and good oral hygiene
- 4: Be willing to receive treatment and regular follow-up and review, and signed the informed consent
Key exclusion criteria (5 listed)
- 1: Uncontrolled systemic diseases, such as heart, liver and kidney diseases, systemic infections, diabetes, etc
- 2: Women who are pregnant or lactating
- 3: Taking bisphosphonates, glucocorticoids and other drugs that affect bone metabolism for a long time or within 5 years
- 4: Patients receiving oral and maxillofacial radiotherapy in the past five years
- 5: Patients suffering uncontrolled periodontal disease
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 |
|---|---|---|
| site preservation surgery with open healingTooth extraction in the aesthetic area of the anterior teeth without the expansion and flap were reduced in the operative area. Site preservation surgery was perfomed using Bio-oss (0.5g, Small granule) and Yinlife PCL membrane (25*25mm size) , with opened wound. | Procedure or surgery | Experimental group |
| site preservation surgery with close suturesTooth extraction in the aesthetic area of the anterior teeth with the expansion and flap were reduced in the operative area. Site preservation surgery was performed using Bio-oss (0.5g, Small granule) and bio-gide (25*25mm size) . The gums were closely drawn and sutured. | Procedure or surgery | Control group |
Primary outcome
soft tissue healing efficiency
Time frame: Immediately after surgery, 7 days, 14 days and 1 month after surgery
After calibrating the magnification ratio of the tooth extraction wound photos, the reduction ratio of the tooth extraction wound area at 7 days, 14 days, 1 month, and 3 months after surgery was calculated based on the immediate postoperative tooth extraction wound photos to evaluate the soft tissue healing efficiency.
1 secondary outcome
Bone healing efficiency
Time frame: Preoperative and postoperative 3 months
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 12 Jan 2026.
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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.
Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing site preservation surgery with open healing and site preservation surgery with close sutures in people with Site Preservation and Soft Tissue Healing, run by The Dental Hospital of Zhejiang University School of Medicine 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 5 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: opening soon, as of the sponsor's last update on 12 Jan 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue healing efficiency (time frame: Immediately after surgery, 7 days, 14 days and 1 month after surgery). 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 12 Jan 2026.