NCT07082634

Brief Summary

Immediate implant placement in the esthetic zone is an approach that helps preserve soft and hard tissue architecture. However, post extraction bone resorption is still a significant challenge. The socket shield technique (SST) has emerged as a promising way for preserving the buccal plate, potentially improving implant stability and reducing radiographic bone loss. The aim of the present study is to evaluate the clinical and radiographic outcomes of the socket shield technique in the maxillary esthetic zone by assessing implant stability, radiographic bone loss as well as esthetic outcome over a specified follow-up period.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress91%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

July 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 15, 2025

Last Update Submit

July 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in pain scores

    Pain will be evaluated, using visual analogue scale (VAS) as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) (Figure 1)

    baseline, 7, 14, and 21 days

  • Change in implant stability

    The base line primary Implant Stability Quotient (ISQ) will be measured at the time of implant placement, while the secondary stability quotient will be measured after 6months during the prosthetic phase preparation.

    baseline and 6 months

Secondary Outcomes (3)

  • Change in post operative healing

    baseline, 7, 14, and 21 days

  • change in crestal alveolar process width

    baseline and 6 months

  • change in labial bone thickness

    baseline and 6 months

Study Arms (1)

Socket shield and immediate implant

EXPERIMENTAL
Procedure: Socket shield concept and immediate implant placement

Interventions

Tooth Sectioning: The tooth will be sectioned mesiodistally using a fissure bur, preserving the buccal segment. Palatal fragment extraction: carefully after sectioning the tooth , the palatal fragment is luxated and extracted with the most important factor is taking care of the buccal part not to become loose , the extraction is done using a periotome to be minimally invasive and to preserve the bone from major damage. Shield Preparation: The buccal fragment is reduced to bone level using a round bur, a beveled edge is created using a diamond football bur, and the shield is thinned to maintain structural integrity. Implant Site Preparation: Sequential osteotomy performed under copious irrigation, ensuring primary stability. Implant Placement: A Megagen implant is inserted

Socket shield and immediate implant

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a non-restorable maxillary tooth in the aesthetic zone indicated for extraction and subsequent immediate implant placement.
  • Patients with extraction socket Type I.
  • A good standard of oral hygiene.

You may not qualify if:

  • Patients with extraction socket Type II or III, with defect in the buccal plate.
  • Absence of at least 2 mm bone apical to the extraction socket, necessary to obtain adequate primary stability for the implant assessed by pre-operative radiographic evaluation.
  • The presence of any local factor that may interfere with extraction as tooth ankylosis.
  • Patients with deciduous teeth.
  • Patients with bruxism
  • Heavy smokers.
  • Systemic conditions that are considered as a contraindication for placement of implant or those that may interfere with wound healing and immunocompromised conditions and uncontrolled autoimmune diseases.
  • History of oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.
  • Patients receiving radiotherapy or chemotheraphy.
  • Patient with active infection or chronic infection with severe bone loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beirut Arab University

Beirut, 11-5020, Lebanon

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 24, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations