Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT07171866
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2025-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socket Shield Technique for Immediate and Delayed Implant Placement: A 6-Year Clinical Tria
Sponsor:
Soaad Tolba Mohammed Tolba Badawi
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SST
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: