Socket Shield Technique for Immediate and Delayed Implant Placement: A 6-Year Clinical Tria

NCT ID: NCT07171866

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2025-07-01

Brief Summary

This study investigates the long-term performance of the Socket Shield Technique (SST) for preserving the bone and soft tissue around dental implants when used with two different timing protocols: immediate versus delayed implant placement.

SST is a surgical technique where a thin portion of the tooth root (the buccal shield) is intentionally retained to support the facial bone and gum tissues after tooth extraction. While SST is known to enhance esthetics and preserve bone in the short term, little evidence exists on its long-term effectiveness in different clinical scenarios.

This randomized clinical trial enrolled patients who needed single-tooth implants in the esthetic zone. Participants were randomly assigned to one of two groups:

Immediate SST group: the implant was placed at the same time the socket shield was prepared.

Delayed SST group: implant placement was performed six months after socket shield preparation.

Over a 6-year follow-up period, both groups were evaluated for:

Changes in ridge width and bone height using CBCT imaging. Esthetic outcomes using the Pink Esthetic Score (PES). Patient satisfaction through a structured questionnaire.

The goal is to determine whether SST offers reliable long-term outcomes in either immediate or delayed implant placement scenarios, supporting its broader clinical use.

Detailed Description

This randomized controlled clinical trial was conducted to compare the long-term clinical, radiographic, esthetic, and patient-reported outcomes of the SST when used with either immediate or delayed implant placement in the anterior maxilla.

Study Design:

Parallel-arm, randomized controlled trial Conducted at the Faculty of Dentistry, Mansoura University Sample: 25 patients needing single-tooth replacement

Groups:

Immediate SST: implant placed at time of shield preparation Delayed SST: implant placed after 6-month healing

Primary Outcome:

Ridge Width Change: measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT imaging at baseline, 1 year, and 6 years.

Secondary Outcomes:

Buccal/Palatal Bone Height Implant Stability Pink Esthetic Score Patient Satisfaction

Serial CBCT scans were superimposed using the Fusion module of OnDemand3D software for precise assessment. All clinical assessments were performed by calibrated, blinded examiners. Statistical analysis was performed using SPSS, with significance set at p < 0.05.

This study provides one of the first long-term comparative evaluations of SST in different implant placement protocols, offering evidence to support its clinical reliability over a 6-year period.

Conditions

Alveolar Ridge Preservation; Implant Dentistry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Implant Placement with SST

Participants received the SST with immediate implant placement performed at the time of extraction.

Group Type: ACTIVE_COMPARATOR

Immediate Implant Placement with SST

Intervention Type: PROCEDURE

Participants underwent extraction and socket shield preparation, followed by immediate implant placement in the esthetic maxillary zone. The implant was inserted at the same surgical session using a flapless or minimally invasive approach. CBCT was used to guide planning and assess ridge dimensions. Healing and follow-up assessments were conducted at 1 year and 6 years post-placement.

Delayed Implant Placement with SST

Participants received the SST with delayed implant placement, performed 6 months after extraction and shield preparation.

Group Type: ACTIVE_COMPARATOR

Delayed Implant Placement with SST

Intervention Type: PROCEDURE

Participants underwent extraction and socket shield preparation. Implant placement was delayed for 6 months to allow soft and hard tissue healing. The implant was placed after verifying shield stability and ridge preservation via CBCT. Follow-up assessments were conducted at 1 year and 6 years post-placement.

Interventions

Immediate Implant Placement with SST

Participants underwent extraction and socket shield preparation, followed by immediate implant placement in the esthetic maxillary zone. The implant was inserted at the same surgical session using a flapless or minimally invasive approach. CBCT was used to guide planning and assess ridge dimensions. Healing and follow-up assessments were conducted at 1 year and 6 years post-placement.

Intervention Type: PROCEDURE

Delayed Implant Placement with SST

Participants underwent extraction and socket shield preparation. Implant placement was delayed for 6 months to allow soft and hard tissue healing. The implant was placed after verifying shield stability and ridge preservation via CBCT. Follow-up assessments were conducted at 1 year and 6 years post-placement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients requiring single-tooth replacement in the anterior maxilla (esthetic zone)
• Age between 18-65 years
• Good systemic health
• Demonstrated good oral hygiene
• Presence of an intact buccal plate
• Class I or II sagittal root position
• Sufficient apical bone volume and quality for implant placement
• Willingness and ability to comply with study protocol and follow-up schedule
• Signed informed consent

Exclusion Criteria

• Presence of acute infection at the extraction site (e.g., abscess)
• Vertical root fracture or advanced periodontitis with buccal plate loss
• Uncontrolled systemic disease (e.g., diabetes, osteoporosis)
• Parafunctional habits (e.g., bruxism, clenching)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soaad Tolba Mohammed Tolba Badawi

OTHER

Sponsor Role: lead

Responsible Party

Soaad Tolba Mohammed Tolba Badawi

Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Soaad Tolba Badawy, Lecturer, Oral Surgery, MU

Role: PRINCIPAL_INVESTIGATOR

Faculty of dentistry, Mansoura university

Locations

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

R.25.09.21

Identifier Type: -

Identifier Source: org_study_id