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ACTIVE NOT RECRUITING
NCT07020767
NA

Effect of Two Incision Techniques on Soft and Hard Tissue Outcomes in Immediate Implant Placement in Class II Extraction Sockets of the Esthetic Zone:

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

This randomized controlled clinical trial investigates the effect of two different surgical approaches-Vestibular Socket Therapy (VST) and Flap Elevation Technique-on soft and hard tissue outcomes during immediate implant placement in Class II extraction sockets of the anterior maxilla (esthetic zone). The study enrolled 26 systemically healthy adult patients contributing a total of 48 surgical sites. Each site was randomly assigned to one of the two treatment groups. The VST group employed a minimally invasive vestibular incision to allow atraumatic extraction, implant placement, bone grafting, and membrane placement while preserving the labial soft tissue and periosteal blood supply. The Flap Elevation group followed a conventional intrasulcular flap approach. In both groups, implants were placed with 30 Ncm torque and augmented with MegaOss™ allograft and a resorbable collagen membrane (T-barrier™). Clinical and radiographic evaluations were conducted at baseline, 6 months, and 12 months post-loading. Outcomes measured included Pink Esthetic Score (PES), peri-implant probing depth (PD), mucosal level changes, and crestal bone level changes.

Official title: Effect of Two Different Incision Techniques on Soft and Hard Tissue Outcomes in Immediate Implant Placement in Class II Extraction Sockets of the Esthetic Zone: A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-01-01

Completion Date

2025-12-01

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

PROCEDURE

Vestibular Socket Therapy (VST) Group

A minimally invasive vestibular incision technique for atraumatic tooth extraction, followed by immediate implant placement using BioHorizons implants. The socket is augmented with MegaOss™ allograft and covered with T-barrier™ collagen membrane, stabilized with membrane tacks. Soft tissue closure is achieved with 7/0 nylon sutures. Customized composite healing abutments are used, and zirconia crowns are delivered at 3 months.

PROCEDURE

Flap Elevation Group

Traditional mucoperiosteal flap elevation with intrasulcular and vertical incisions, followed by atraumatic extraction and immediate implant placement using BioHorizons implants. The socket is grafted with MegaOss™ allograft, covered with T-barrier™ collagen membrane, and stabilized with tacks. The site is closed with 7/0 nylon sutures. Healing abutments and zirconia crowns are applied following the same timeline as the VST group.

Locations (1)

Nermeen Nagi

Al Fayyum, Faiyum Governorate, Egypt