NCT07171866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

6.4 years

First QC Date

September 6, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

Socket Shield TechniqueImmediate Implant PlacementDelayed Implant PlacementCBCTRidge Width ChangePink Esthetic ScoreAlveolar Ridge PreservationLong-term Implant Outcomes

Outcome Measures

Primary Outcomes (1)

  • Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform

    Ridge width was measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT scans. Superimposed scans were aligned using the Fusion module of OnDemand3D™ software. Changes in horizontal ridge width were calculated by subtracting baseline values from those at 1 year and 6 years to assess dimensional stability over time. Unit of Measure: → Millimeters (mm) Safety Issue: → No

    Immediately after implant placement (baseline), 1 year, and 6 years post-placement

Secondary Outcomes (4)

  • Buccal and Palatal Bone Height Change

    Immediately after implant placement (baseline), 1 year, and 6 years post-placement

  • Implant Stability Quotient (ISQ)

    Immediately after implant placement, loading time and 1-year post-placement

  • Pink Esthetic Score (PES)

    At implant loading, 1 year, and 6 years post-placement

  • Patient Satisfaction (VAS Score)

    At implant loading, 1 year, and 6 years post-placement

Study Arms (2)

Immediate Implant Placement with SST

ACTIVE COMPARATOR

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

Procedure: Immediate Implant Placement with SST

Delayed Implant Placement with SST

ACTIVE COMPARATOR

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

Procedure: Delayed Implant Placement with SST

Interventions

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.

Immediate 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.

Delayed Implant Placement with SST

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

  • Soaad Tolba Badawy, Lecturer, Oral Surgery, MU

    Faculty of dentistry, Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The radiographic outcomes assessor was blinded to group allocation. No other masking was implemented due to the surgical nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized into two parallel groups: one receiving immediate implant placement and the other delayed placement following the SST. Each group followed the assigned intervention protocol throughout the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University

Study Record Dates

First Submitted

September 6, 2025

First Posted

September 15, 2025

Study Start

February 1, 2019

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The individual participant data will not be shared due to privacy considerations, and limitations in participant consent regarding external data sharing.

Locations