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

NCT07822685 | Not Yet Recruiting

• 1 other identifier: KY2026-421
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Teeth Absent; Teeth Missing; Dental Implant

Keywords

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

Outcome Measures

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

  6 months after the restoration (T3)

Secondary Outcomes (5)

• Implant retention and success rate

  3, 6,12 ,24 and 36 months after the operaiton

• Volume change of the labial bone plate

  6 months after the crown restoration was completed

• Change in the contour curvature of soft tissues

  6 months after the crown restoration was completed

• Pink Aesthetic Score (PES)

  6 months after the crown restoration was completed

• Patients' satisfaction degree

  On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed

Study Arms (2)

the Socket Shield Technique (SST)

EXPERIMENTAL

the Socket Shield Technique (SST) immediate implant placement

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

conventional immediate implant placement (IIP)

ACTIVE COMPARATOR

Procedure: Conventional immediate implant placement

Interventions

Conventional immediate implant placement PROCEDURE

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

conventional immediate implant placement (IIP)

the Socket Shield Technique (SST) immediate implant placement PROCEDURE

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

the Socket Shield Technique (SST)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ding Xi, PhD

CONTACT

86+13857707636; dingxi@wzhospital.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Stomatology

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share