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

NCT07468760 | Not Yet Recruiting DMC

• 1 other identifier: IRB-COD-STD-87-Feb-2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Socket Shield Technique; Immediate Implant Placement; Early Implant Placement; Pink Esthetic Score; Partial Extraction Therapy; Buccal Bone Remodeling

Outcome Measures

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.

  12 months after implant restoration

Secondary Outcomes (4)

• Peri-implant Mid-facial Mucosal Recession

  12 months after implant placement

• Horizontal Radiographic Peri-implant Bone Changes

  12 months after implant Restoration

• Vertical Radiographic Peri-implant Bone Changes

  12 months after implant Restoration

• Patient Satisfaction

  12 months after implant restoration

Study Arms (2)

Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech

EXPERIMENTAL

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

Early Type II Implant placement with Contour augmentation with Xenograft

ACTIVE COMPARATOR

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

Interventions

Socket Shield PROCEDURE

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

Also known as: Partial Extraction Therapy

Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech

Early Implant Placement PROCEDURE

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

Also known as: Type II Implant Placement

Early Type II Implant placement with Contour augmentation with Xenograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Intact socket walls following tooth extraction
• Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
• Patients willing to participate in the study and able to provide written informed consent

You may not qualify if:

• 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
• Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
• Presence of internal or external root resorption
• Severe periodontal destruction at the implant site

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Mohamed Atef Sayed, Ph.D.

  Assistant Professor of Periodontics

  STUDY CHAIR

• Moheb Silwadi, M.D.S

  Gulf Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Atef Sayed, Ph.D

CONTACT

+971581069908; dr.mohamedatef@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The present study is a single-blinded randomized clinical trial. Due to the nature of the surgical interventions, neither the operator performing the procedure nor the participants can be blinded to the treatment allocation. However, the outcome assessor responsible for evaluating the clinical photographs, digital scans, and radiographic measurements will be blinded to group allocation. In addition, the statistician performing the data analysis will also be blinded to the treatment groups to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center, prospective, randomized parallel two-arm clinical trial. A total of 42 patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly assigned in a 1:1 ratio to either the test group or the control group using a computer-generated randomization list. The test group will receive immediate implant placement with the socket shield technique and immediate restoration, while the control group will receive early type II implant placement following a healing period of 4-8 weeks with contour augmentation. Outcome assessors and the statistician will be blinded to the treatment allocation. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)