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NCT Number: NCT07761442

Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.

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.

Recruiting

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

(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

Treatment and study plan

Conventional technique

Procedure

Immediate Implant Placement Using Conventional Technique

Socket-Shield Technique

Procedure

Immediate Implant Placement Using Socket-Shield Technique

Primary outcomes

  1. Change in Bone Density Around Immediate Implants.

    Time frame: At baseline of implant placement then after 9 months

    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.

  2. Change in Marginal Bone Level Around Immediate Implants.

    Time frame: At baseline of implant placement then after 9 months.

    • 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).

Secondary outcomes

  1. Change in Probing Depth (PD)

    Time frame: 3 months, 6 months, and 9 months post-surgery.

    Measurement of the distance from the peri-implant mucosal margin to the bottom of the clinical pocket using a calibrated periodontal probe.

    Unit of Measure: Millimeters (mm)

  2. Modified Gingival Index (MGI)

    Time frame: 3 months, 6 months, and 9 months post-surgery.

    Assessment of the visual signs of inflammation of the peri-implant soft tissues. Scores range from 0 to 4 (0 = Normal, 1 = Mild inflammation, 2 = Mild inflammation with color change, 3 = Moderate inflammation, 4 = Severe inflammation).

    Unit of Measure: Score on a scale (0-4)

  3. Modified Plaque Index (MPI)

    Time frame: 3 months, 6 months, and 9 months post-surgery.

    Assessment of the amount of plaque on the implant/restoration surface. Scores range from 0 to 3 :

    • 0 = No plaque
    • 1 = Plaque only recognized by running a probe
    • 2 = Plaque visible to the naked eye
    • 3 = Abundance of soft matter).

    Unit of Measure: Score on a scale (0-3)

  4. Gingival Thickness (GT)

    Time frame: Baseline, 3 months, 6 months, and 9 months post-surgery.

    Assessment of the thickness of the peri-implant mucosa. This will be measured using a digital caliper or endodontic file with a rubber stopper 2mm apical to the gingival margin.

    Unit of Measure: Millimeters (mm)

  5. Width of Keratinized Tissue (KTW)

    Time frame: Baseline, 3 months, 6 months, and 9 months post-surgery.

    Measured from the gingival margin to the mucogingival junction at the mid-facial aspect of the implant site.

    Unit of Measure: Millimeters (mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Omar I Wahedi

CONTACT

[email protected]

+201064769520

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Comparative Study Between Using Socket Shield And Conventional Techniques In Immediate Implant Placement (A Randomized Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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