NCT07761442

Brief Summary

The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone. This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement. The main questions this study aims to answer are: Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique? Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness? participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique. Participants will:

  • Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT).
  • Receive immediate implant placement using either the conventional technique or the socket-shield technique.
  • Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing.
  • Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
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 Progress79%
Oct 2025Nov 2026

Study Start

First participant enrolled

October 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

December 15, 2025

Last Update Submit

August 10, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Bone Density Around Immediate Implants.

    Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value. Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement Measure Description: Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone.

    At baseline of implant placement then after 9 months

  • Change in Marginal Bone Level Around Immediate Implants.

    * Linear measurement of the distance from the implant platform to the first bone-to-implant contact point to assess crestal bone stability. * Unit of measure : Millimeters (mm).

    At baseline of implant placement then after 9 months.

Secondary Outcomes (5)

  • Change in Probing Depth (PD)

    3 months, 6 months, and 9 months post-surgery.

  • Modified Gingival Index (MGI)

    3 months, 6 months, and 9 months post-surgery.

  • Modified Plaque Index (MPI)

    3 months, 6 months, and 9 months post-surgery.

  • Gingival Thickness (GT)

    Baseline, 3 months, 6 months, and 9 months post-surgery.

  • Width of Keratinized Tissue (KTW)

    Baseline, 3 months, 6 months, and 9 months post-surgery.

Study Arms (2)

GROUP I

ACTIVE COMPARATOR

Immediate Implant Placement Using Conventional Technique

Procedure: Conventional Technique

GROUP II

EXPERIMENTAL

Immediate Implant Placement Using Socket-Shield Technique

Procedure: Socket-Shield Technique

Interventions

Immediate Implant Placement Using Conventional Technique

GROUP I

Immediate Implant Placement Using Socket-Shield Technique

GROUP II

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged between 20 and 60 years of both genders
  • All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index.
  • Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018).
  • Presence of non-restorable teeth due to trauma, complicated crowns or root fractures.
  • Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones.
  • Clinical indication for immediate implant placement, especially in cases where minimizing post-extraction bone resorption and soft tissue collapse is critical.
  • Availability of adequate interocclusal space to accommodate the necessary prosthetic components without occlusal interference.

You may not qualify if:

  • (for socket-shield technique)
  • Pregnant female.
  • Patients with parafunctional habits (e.g., bruxism, clenching).
  • Smokers.
  • Teeth with clinical mobility.
  • Teeth with root fractures extending below the alveolar bone level.
  • Periodontal ligament space widening.
  • Signs of internal or external root resorption.
  • Current or previous periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Egypt

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2025

First Posted

August 12, 2026

Study Start

October 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations