Effect of Subepithelial Connective Tissue Graft with Socket Shield Technique

Effect of Subepithelial Connective Tissue Graft with Socket Shield Technique on Periimplant Tissues in Immediate Implant Procedure

The goal of this clinical trial is to Evaluate of the soft tissue profile changes and labial plate of bone in the anterior esthetic area when using socket shield technique in conjunction with immediate implant and subepithelial connective tissue graft, in comparison to using immediate implant combined by subepithelial connective tissue graft. The main questions it aims to answer is :

• does the socket shield technique better preserve gingival contours and connective tissues, resulting in improved esthetic outcomes?
• Researchers will compare socket shield combined with immediate implant placement and a subepithelial connective tissue graft to immediate implant placement with just a subepithelial connective tissue graft to see if more favorable soft tissue profile changes and better preservation of the labial plate of bone are obtained.

participants will :

. subjected to partially extracted socket with immediately placed implant and subepithelial connective tissue graft.

.subjected to immediate implant with subepithelial connective tissue graft.

Study Overview

• Status: Active, not recruiting
• Conditions: Immediate Implant Placement; Socket Shield Technique Implant Placement
• Intervention / Treatment: Procedure: implant placement; Procedure: socket shield technique; Procedure: subepithelial connective tissue graft

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 3753450
    • faculty of dentistry -Ain shams university

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Medically free
• Maxillary esthetic zone extended to the second premolar with healthy roots
• Good oral hygiene
• Hopeless teeth

Exclusion Criteria:

• Patients with systemic conditions that can affect bone turnover
• Smokers
• Pregnant women
• Chronic and active periodontal disease
• Vertical and horizontal root fracture
• Dehiscence or fenestration of the labial plate of bone
• Gingival recession

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: socket shield technique	Procedure: implant placement; implant placement; Procedure: socket shield technique; partial extraction therapy : sectioning the root and keeping part of it in contact with labial plate of bone; Other Names: partial extraction therapy; Procedure: subepithelial connective tissue graft; A connective tissue graft harvesting from maxillary tuberosity area
Experimental: immediate implant placement	Procedure: implant placement; implant placement; Procedure: subepithelial connective tissue graft; A connective tissue graft harvesting from maxillary tuberosity area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of soft tissue profile around the implant	- Scanning of preoperative and postoperative cast , then Volumetric analysis of soft tissue by Superimposing the scans to evaluate the changes in the soft tissues in millimeters.	change from baseline at six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of labial plate of bone around the implant	Preoperative CBCT to measure thickness, height and density of existent labial plate of bone in millimeters at baseline. Then, six months later, a CBCT is carried out to measure the difference between these measurements in millimeters.	change from baseline at six months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Hala A. Abo el ela, professor, Faculty of Dentistry- Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: partial extraction therapy
• Other Study ID Numbers: FDASU-Rec IM122333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only IPD used in the results publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No