Teeth AbsentNCT07822685
Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone
A study testing the Socket Shield Technique (SST) immediate implant placement and Conventional immediate implant placement in people with Teeth Absent and Teeth Missing, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
This study plans to enroll no fewer than 48 adult patients who have non-restorable maxillary anterior teeth due to trauma or dental diseases and are candidates for immediate implant placement, meeting the inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Teeth Absent, Teeth Missing, Dental Implant
- What is being tested?
- the Socket Shield Technique (SST) immediate implant placement and Conventional immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years old;
- Good general health, able to tolerate oral implant surgery, with no absolute surgical contraindications (ASA I or II);
- Clinical diagnosis of an unrestorable maxillary anterior tooth, suitable for immediate implant placement; ④ Periodontal tissues are basically healthy, with no obvious active infection in the apical area; ⑤ No obvious root fracture on the labial/buccal side or severe mobility preoperatively; radiographic evaluation confirms that the bone volume in the surgical site meets the requirements of the protocol; ⑥ Willing to accept randomization and standardized follow-up, and has signed the Informed Consent Form; ⑦ Able to provide complete intraoral photographs, CBCT (Cone Beam Computed Tomography) scans, and follow-up data.
Who cannot join
- Presence of severe systemic diseases that may affect the surgery or healing, or current use of related medications such as bisphosphonates;
- Severe periodontal disease or uncontrolled poor oral hygiene;
- Obvious inflammation in the apical area of the affected tooth, or pathological root resorption; ④ Abnormal occlusal relationship, obvious bruxism, or inability to establish a stable restorative occlusion;
- Pregnancy or lactation, or unsuitability for radiographic examination; ⑥ History of previous surgery or radiotherapy affecting the bone volume or soft tissues in the target area, which the investigator deems would seriously interfere with the evaluation; ⑦ Expected inability to complete the follow-up, or refusal to comply with the study requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study plans to enroll no fewer than 48 adult patients who have non-restorable maxillary anterior teeth due to trauma or dental diseases and are candidates for immediate implant placement, meeting the inclusion and exclusion criteria.
Read the detailed description
This is a prospective, multicenter, parallel-group, evaluator-blinded randomized controlled trial.It aims to compare the Socket Shield Technique (SST) with conventional immediate implant placement (IIP) in the maxillary anterior aesthetic zone, evaluating labial bone plate thickness, implant survival/success rates, pink aesthetics, and patient satisfaction to assess their clinical efficacy and aesthetic outcomes.
Eligible participants will provide informed consent and be randomly assigned to groups via center-stratified randomization.
Primary endpoint: Changes in buccal bone plate thickness at the implant shoulder and at 2, 4, and 6 mm apically at 6 months after prosthetic restoration (T3).
Secondary endpoints: Implant survival and success rates; changes in buccal bone volume; changes in soft tissue contour convexity; Pink Esthetic Score (PES); patient satisfaction; operative time, pain levels, and treatment-related parameters.
Safety endpoints: Intraoperative and postoperative adverse events, including infection, bleeding, wound dehiscence, implant loosening, peri-implantitis, shield fragment displacement/exposure/dislodgement, need for reoperation, and other serious adverse events (SAEs).
- Conditions
- Teeth Absent, Teeth Missing, Dental Implant
- Being tested
- the Socket Shield Technique (SST) immediate implant placement, Conventional immediate implant placement
- Keywords
- Socket Shield Technique (SST), Immediate Implant Placement (IIP), Buccal bone plate thickness
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Socket Shield Technique (SST) immediate implant placementProcedure or surgery
Also called Group SST
During tooth extraction, a stable buccal root fragment (shield) is preserved. The specific procedures are as follows:
Minimally invasively extract the crown of the affected tooth, preserving a buccal root fragment approximately 1-2 mm in thickness; Adjust the coronal aspect of the root fragment to approximately 2 mm apical to the gingival margin, ensuring a rounded and blunt coronal edge that is flush with the alveolar crest; Maintain the integrity of the buccal bone plate without any fractures;
Conventional immediate implant placementProcedure or surgery
Also called Group IIP
Completely remove the root of the affected tooth and complete the procedure according to the conventional immediate implant placement protocol:
Minimally invasively extract the affected tooth (complete root extraction); Place the implant within the extraction socket (biased toward the palatal side); Fill the jump gap with a low-resorption xenogeneic bone substitute material; Perform soft and hard tissue management according to the conventional immediate implant placement SOP.
| Study group | Role | What they receive |
|---|---|---|
| the Socket Shield Technique (SST) | Experimental | the Socket Shield Technique (SST) immediate implant placement Receives: Procedure: the Socket Shield Technique (SST) immediate implant placement |
| conventional immediate implant placement (IIP) | Active comparator | Not described Receives: Procedure: Conventional immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the labial bone plate
The changes in the thickness of the labial bone plate at the implant shoulder and 2, 4, and 6 mm below
Measured: 6 months after the restoration (T3)
Secondary outcomes (5)
Implant retention and success rate
Measured: 3, 6,12 ,24 and 36 months after the operaiton
Volume change of the labial bone plate
Measured: 6 months after the crown restoration was completed
Change in the contour curvature of soft tissues
Measured: 6 months after the crown restoration was completed
Pink Aesthetic Score (PES)
Measured: 6 months after the crown restoration was completed
Patients' satisfaction degree
Measured: On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth AbsentStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Ding, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822685
- Sponsor's protocol ID
- KY2026-421
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT07822685
- Acronym / sponsor ID
- KY2026-421
- Conditions
- Teeth Absent, Teeth Missing, Dental Implant
- Keywords
- Socket Shield Technique (SST), Immediate Implant Placement (IIP), Buccal bone plate thickness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Sep 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.
This study plans to enroll no fewer than 48 adult patients who have non-restorable maxillary anterior teeth due to trauma or dental diseases and are candidates for immediate implant placement, meeting the inclusion and exclusion criteria.
Detailed description
This is a prospective, multicenter, parallel-group, evaluator-blinded randomized controlled trial.It aims to compare the Socket Shield Technique (SST) with conventional immediate implant placement (IIP) in the maxillary anterior aesthetic zone, evaluating labial bone plate thickness, implant survival/success rates, pink aesthetics, and patient satisfaction to assess their clinical efficacy and aesthetic outcomes.
Eligible participants will provide informed consent and be randomly assigned to groups via center-stratified randomization.
Primary endpoint: Changes in buccal bone plate thickness at the implant shoulder and at 2, 4, and 6 mm apically at 6 months after prosthetic restoration (T3).
Secondary endpoints: Implant survival and success rates; changes in buccal bone volume; changes in soft tissue contour convexity; Pink Esthetic Score (PES); patient satisfaction; operative time, pain levels, and treatment-related parameters.
Safety endpoints: Intraoperative and postoperative adverse events, including infection, bleeding, wound dehiscence, implant loosening, peri-implantitis, shield fragment displacement/exposure/dislodgement, need for reoperation, and other serious adverse events (SAEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Socket Shield Technique (SST) | Experimental | Procedure: the Socket Shield Technique (SST) immediate implant placementthe Socket Shield Technique (SST) immediate implant placement |
| conventional immediate implant placement (IIP) | Active comparator | Procedure: Conventional immediate implant placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 to 65 years old;
Key exclusion criteria (4 listed)
- Presence of severe systemic diseases that may affect the surgery or healing, or current use of related medications such as bisphosphonates;
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 |
|---|---|---|
| the Socket Shield Technique (SST) immediate implant placementAlso: Group SSTDuring tooth extraction, a stable buccal root fragment (shield) is preserved. The specific procedures are as follows: Minimally invasively extract the crown of the affected tooth, preserving a buccal root fragment approximately 1-2 mm in thickness; Adjust the coronal aspect of the root fragment to approximately 2 mm apical to the gingival margin, ensuring a rounded and blunt coronal edge that is flush with the alveolar crest; Maintain the integrity of the buccal bone plate without any fractures; | Procedure or surgery | the Socket Shield Technique (SST) |
| Conventional immediate implant placementAlso: Group IIPCompletely remove the root of the affected tooth and complete the procedure according to the conventional immediate implant placement protocol: Minimally invasively extract the affected tooth (complete root extraction); Place the implant within the extraction socket (biased toward the palatal side); Fill the jump gap with a low-resorption xenogeneic bone substitute material; Perform soft and hard tissue management according to the conventional immediate implant placement SOP. | Procedure or surgery | conventional immediate implant placement (IIP) |
Primary outcome
Thickness of the labial bone plate
Time frame: 6 months after the restoration (T3)
The changes in the thickness of the labial bone plate at the implant shoulder and 2, 4, and 6 mm below
5 secondary outcomes
Implant retention and success rate
Time frame: 3, 6,12 ,24 and 36 months after the operaiton
Volume change of the labial bone plate
Time frame: 6 months after the crown restoration was completed
Change in the contour curvature of soft tissues
Time frame: 6 months after the crown restoration was completed
Pink Aesthetic Score (PES)
Time frame: 6 months after the crown restoration was completed
Patients' satisfaction degree
Time frame: On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed
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 16 Sep 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.
Questions about this trial
What is this clinical trial studying?
A study testing the Socket Shield Technique (SST) immediate implant placement and Conventional immediate implant placement in people with Teeth Absent and Teeth Missing, run by First Affiliated Hospital of Wenzhou Medical University.
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 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ding Xi, PhD (86+13857707636, dingxi@wzhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the labial bone plate (time frame: 6 months after the restoration (T3)). 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 16 Sep 2026.