NCT07468760

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

Evaluation of Peri-implant Hard And Soft Tissues Changes Between Immediate Implant Placement With Socket Shield Technique and Immediate Restoration Versus Early Type II Implant Placement in The Esthetic Zone - A Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Gulf Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture. This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation. Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups: Test group: Immediate implant placement with socket shield technique and immediate restoration. Control group: Early implant placement following soft tissue healing with contour augmentation. Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.

Conditions

• Tooth Loss in the Anterior Maxilla
• Alveolar Bone Resorption
• Partial Edentulism of the Maxilla

Interventions

Type	Name	Description
PROCEDURE	Socket Shield	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
PROCEDURE	Early Implant Placement	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

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United Arab Emirates