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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant female.

Patients with parafunctional habits (e.g., bruxism, clenching).

Smokers.

Teeth with clinical mobility.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Technique

    Procedure/Surgery

    Immediate Implant Placement Using Conventional Technique

  • Socket-Shield Technique

    Procedure/Surgery

    Immediate Implant Placement Using Socket-Shield Technique

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: GROUP IActive comparator 1 intervention
Group B: GROUP IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline of implant placement then after 9 months
2

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).

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

Secondary outcomes

1

Change in Probing Depth (PD)

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)

Time frame
3 months, 6 months, and 9 months post-surgery.
2

Modified Gingival Index (MGI)

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)

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

Modified Plaque Index (MPI)

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)

Time frame
3 months, 6 months, and 9 months post-surgery.
4

Gingival Thickness (GT)

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.