ClinicalTrials.gg
Not yet recruitingNCT07822685Updated Sep 16, 2026

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

An interventional study of the Socket Shield Technique (SST) immediate implant placement and Conventional immediate implant placement in Teeth Absent, Teeth Missing and Dental Implant, sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by First Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Teeth Absent
  • Teeth Missing
  • Dental Implant

Keywords

  • Socket Shield Technique (SST)
  • Immediate Implant Placement (IIP)
  • Buccal bone plate thickness
03

In context

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 83 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18 to 65 years old;

    • Good general health, able to tolerate oral implant surgery, with no absolute surgical ();

      • 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 Form; ⑦ Able to provide complete intraoral photographs, CBCT (Cone Beam Computed Tomography) scans, and follow-up data.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    the Socket Shield Technique (SST)

    the Socket Shield Technique (SST) immediate implant placement

    Procedure: the Socket Shield Technique (SST) immediate implant placement

  • Active comparator
    conventional immediate implant placement (IIP)

    Procedure: Conventional immediate implant placement

Interventions

  • Procedurethe Socket Shield Technique (SST) immediate implant placement

    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;

    Also known as: Group SST

  • ProcedureConventional immediate implant placement

    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.

    Also known as: Group IIP

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months after the restoration (T3)

Secondary outcomes

  1. Implant retention and success rate

    Time frame: 3, 6,12 ,24 and 36 months after the operaiton

  2. Volume change of the labial bone plate

    Time frame: 6 months after the crown restoration was completed

  3. Change in the contour curvature of soft tissues

    Time frame: 6 months after the crown restoration was completed

  4. Pink Aesthetic Score (PES)

    Time frame: 6 months after the crown restoration was completed

  5. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 16, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2029
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07822685
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Responsible party
Xi Ding (Chief of the Department of Stomatology, First Affiliated Hospital of Wenzhou Medical University) — Principal investigator
First posted
Sep 16, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 16, 2026

Study contacts

Ding Xi, PhD
Contact
dingxi@wzhospital.cn
86+13857707636

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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