Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla

Supra-Implant Complex Stability Following Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla 1-Year Randomized Clinical Trial

The present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Three-dimensional volumetric analysis and cone-beam computed tomography (CBCT) will be employed to assess and quantify changes in soft and hard tissue thickness and height surrounding the implant site.

Study Overview

• Status: Not yet recruiting
• Conditions: Connective Tissue Graft; Socket Shield Technique; Immediate Dental Implant Placement
• Intervention / Treatment: Procedure: IIP+Socket Shield; Procedure: IIP+CTG

Detailed Description

The current study will include 28 non-restorable single maxillary anterior teeth indicated for extraction. Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan Gamal AbdelAziz, Masters; Phone Number: +201064249441; Email: Nourhannegamal259@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • International Dental Contiuing Education
    • Contact: Nourhan Gamal Dr. Nourhan Gamal, Masters; Phone Number: +201064249442; Email: Nourhannegamal259@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Initial intact thick gingival biotype
• 2 mm band of keratinized tissue,
• Thin intact labial bone plate (< 1mm)
• Good apical bone for primary stability
• Patients who had provided an informed consent.

Exclusion Criteria:

• Immediate implants with bone grafts or guided bone regeneration procedures
• Uncontrolled diabetes mellitus
• Patients taking IV bisphosphonates for treatment of osteoporosis
• Patients with active infection related at the site of implant
• Patients with untreated active periodontal diseases.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IIP+ Socket sheild; The socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support	Procedure: IIP+Socket Shield; The socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support.
Active Comparator: IIP+CTG; connective tissue grafting which increases soft-tissue volume	Procedure: IIP+CTG; connective tissue grafting which increases soft-tissue volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue Volume gain/loss	The volumetric analysis in this clinical trial will be performed to obtain profilometric measurements. intraoral scans will be taken at baseline, 6- and 12-month post-operative for each patient. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. Unchanged neighboring teeth surfaces will be used as a reference for proper superimposition. In each patient, the AOI will be kept constant for all pairwise comparisons. The volumetric analysis software will calculate the overall buccal soft tissue volume loss/gain (mm3) within the AOI for each patient.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid-facial gingival margin level	linear change of the Mid-facial gingival margin pre- and after one year	12 months

Collaborators and Investigators

• Sponsor: International Dental Contiuing Education
• Investigators: Principal Investigator: Nael Adel Mina, Masters, International Dental Contiuing Education

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Connective tissue graft; Socket Shield
• Other Study ID Numbers: IDCE-38122025

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