Clinical Trials Directory

Trials / Completed

CompletedNCT07171866

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

From Esthetics to Function: Can Socket Shield Technique Prove Long-term Effectiveness Either With Immediate or Delayed Implant Placement Protocols? A 6-Year Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Soaad Tolba Mohammed Tolba Badawi · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREImmediate Implant Placement with SSTParticipants 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.
PROCEDUREDelayed Implant Placement with SSTParticipants 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.

Timeline

Start date
2019-02-01
Primary completion
2025-07-01
Completion
2025-07-01
First posted
2025-09-15
Last updated
2025-09-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07171866. Inclusion in this directory is not an endorsement.