Peri-Implant Hard and Soft Tissue Changes After Immediate Implant Placement With Socket Shield and Immediate Restoration Versus Early Implant Placement in the Esthetic Zone

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGulf Medical University

About this trial

This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 years or older

Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement

Presence of a thin buccal bone plate (<1 mm)

Adequate bone volume to allow implant placement in a prosthetically ideal position

Disqualifiers

History of systemic diseases that may affect bone healing

Use of medications that may influence bone metabolism (e.g., bisphosphonates)

Smoking within the past 5 years

Presence of acute infection at the surgical site or adjacent teeth

Trial design

Design model

Parallel

Treatments tested in this trial

  • Socket Shield

    Procedure/Surgery

    mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months

  • Early Implant Placement

    Procedure/Surgery

    atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Immediate Implant Placement and Immediate Restoration with the Socket Shield TechExperimental treatment 1 intervention
Group B: Early Type II Implant placement with Contour augmentation with XenograftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pink Esthetic Score (PES)

Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome.

Time frame
12 months after implant restoration

Secondary outcomes

1

Peri-implant Mid-facial Mucosal Recession

Measurement of vertical changes in the mid-facial peri-implant mucosal level. Digital intraoral scans obtained at baseline and during follow-up will be superimposed using digital analysis software to quantify the vertical displacement of the facial mucosal zenith relative to the baseline position.

Time frame
12 months after implant placement
2

Horizontal Radiographic Peri-implant Bone Changes

Assessment of horizontal dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The horizontal distance between the implant surface and the outer surface of the buccal bone plate will be measured at the mid-buccal aspect 1 mm apical to the buccal bone crest. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine peri-implant bone remodeling.

Time frame
12 months after implant Restoration
3

Vertical Radiographic Peri-implant Bone Changes

Assessment of vertical dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The vertical distance between the implant platform and the buccal alveolar crest at the mid-buccal aspect of the implant will be measured. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine vertical peri-implant bone remodeling.

Time frame
12 months after implant Restoration
4

Patient Satisfaction

Patient-reported satisfaction with the implant treatment will be assessed using a Visual Analog Scale (VAS) questionnaire evaluating esthetics and functional outcomes of the implant-supported restoration. The VAS ranges from 0 to 10, where higher scores indicate greater patient satisfaction.

Time frame
12 months after implant restoration

Other outcomes

Sponsors and contacts

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