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Not yet recruitingNCT07468760Updated Mar 13, 2026

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

An interventional study of Socket Shield and Early Implant Placement in Tooth Loss in the Anterior Maxilla, Alveolar Bone Resorption and Partial Edentulism of the Maxilla, sponsored by Gulf Medical University. Not yet recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Gulf Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Gulf Medical University is the lead sponsor of 40 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSocket 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

    Also known as: Partial Extraction Therapy

  • ProcedureEarly 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

    Also known as: Type II Implant Placement

06

What researchers measure

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

07

Study locations

1 site
  • Gulf Medical University
    Ajman, 4184, United Arab Emirates
    • Mohamed Atef Sayed, Ph.D. · Contact · dr.mohamedatef@gmu.ac.ae · +971581069908
    • Mohamed Atef Sayed, Ph.D. · Sub investigator
    • Moheb Silwadi, M.D.S · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07468760
Lead sponsor
Gulf Medical University
Responsible party
Sponsor
First posted
Mar 13, 2026
Start date
Mar 30, 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Mar 13, 2026

Study contacts

Mohamed Atef Sayed, Ph.D
Contact
dr.mohamedatef@gmu.ac.ae
+971581069908 ext. 1441
Mohamed Atef Sayed, Ph.D.
study chair · Assistant Professor of Periodontics
Moheb Silwadi, M.D.S
principal investigator · Gulf Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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