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

NCT07020767 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Immediate Dental Implant
  • Tooth Extraction
  • Class II Extraction Sockets
  • Esthetic Zone Implantology

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.

Sponsors & Collaborators

  • Fayoum University

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Fatma E.Sayed Hassanein · Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020767 on ClinicalTrials.gov