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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Resorption; Partial Edentulism of the Maxilla; Tooth Loss in the Anterior Maxilla
• Intervention / Treatment: Procedure: Socket Shield; Procedure: Early Implant Placement

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Atef Sayed, Ph.D; Phone Number: 1441 +971581069908; Email: dr.mohamedatef@gmu.ac.ae

Study Locations

• United Arab Emirates
  • Ajman, United Arab Emirates, 4184
    • Gulf Medical University
    • Sub-Investigator: Mohamed Atef Sayed, Ph.D.
    • Contact: Mohamed Atef Sayed, Ph.D.; Phone Number: 1441 +971581069908; Email: dr.mohamedatef@gmu.ac.ae
    • Principal Investigator: Moheb Silwadi, M.D.S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adults aged 18 years or older
2. Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
3. Presence of a thin buccal bone plate (<1 mm)
4. Adequate bone volume to allow implant placement in a prosthetically ideal position
5. Intact socket walls following tooth extraction
6. Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
7. Patients willing to participate in the study and able to provide written informed consent

Exclusion Criteria:

1. History of systemic diseases that may affect bone healing
2. Use of medications that may influence bone metabolism (e.g., bisphosphonates)
3. Smoking within the past 5 years
4. Presence of acute infection at the surgical site or adjacent teeth
5. Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
6. Presence of internal or external root resorption
7. Severe periodontal destruction at the implant site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech; Participants allocated to this experimental group will undergo immediate 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. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.	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; Other Names: Partial Extraction Therapy
Active Comparator: Early Type II Implant placement with Contour augmentation with Xenograft; Participants assigned to this active comparator group will undergo 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. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes.	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; Other Names: Type II Implant Placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after implant restoration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after implant placement
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.	12 months after implant Restoration
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.	12 months after implant Restoration
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.	12 months after implant restoration

Collaborators and Investigators

• Sponsor: Gulf Medical University
• Investigators: Study Chair: Mohamed Atef Sayed, Ph.D., Assistant Professor of Periodontics; Principal Investigator: Moheb Silwadi, M.D.S, Gulf Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Socket Shield Technique; Immediate Implant Placement; Pink Esthetic Score; Early Implant Placement; Partial Extraction Therapy; Buccal Bone Remodeling
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Oral Surgical Procedures; Prosthodontics; Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Immediate Dental Implant Loading
• Other Study ID Numbers: IRB-COD-STD-87-Feb-2025 (Other Identifier: Gulf Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No