Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets

NCT06324747 | Completed

• 1 other identifier: 23-046
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone. The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise.

Conditions

Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant

Outcome Measures

Primary Outcomes (1)

• Soft Tissue Stability

  it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 2 months postoperative and 8 months postoperative scanning will be done. Tool to be used: 3shape trios 4 what will be assessed: * gingival recession * loss of interdental papillae height Data will be measured in millimeters

  8 months

Secondary Outcomes (1)

• Bone Regeneration

  8 months

Other Outcomes (1)

• Pink Esthetic Score (PES)

  8 months

Study Arms (2)

Control group

OTHER

Control group will have a full thickness flap, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position.

Procedure: conventional full thickness flap

Test group

ACTIVE COMPARATOR

Elaskary Vestibular socket therapy instruments will be used for the intervention, A 1 cm long vestibular access incision at the allocated hopeless tooth will be made at the base of the hopeless tooth to the adjacent teeth. The vestibular pouch will then be dissected in an incisal direction exposing the total socket area and allowing direct access to the socket environment. An immediate implant will be installed using a surgical guide. A membrane shield 1 mm thick will be, trimmed, and tucked through the vestibular access incision starting at 1 mm beyond the socket orifice and reaching to the apical area of the socket. The gap and/ or the defect between the implant body and the shield will then be filled with the same grafting components so the control group. Finally, the vestibular incision will be secured with sutures. The socket will be sealed with a customized healing abutment.

Procedure: Vestibular socket therapy

Interventions

Vestibular socket therapy PROCEDURE

Vestibular socket therapy will be used for the intervention.

Also known as: VST

Test group

conventional full thickness flap PROCEDURE

reflecting the mucoperiosteum to access the extraction socket

Control group

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Hopeless maxillary tooth in the esthetic region missing coronal tooth structure
• Type II socket (deficient labial plate of bone and intact overlying soft tissues)
• Adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants

You may not qualify if:

• Smokers
• Pregnant women
• Patients with systemic diseases
• History of chemotherapy or radiotherapy within the past 2 years.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British university in Egypt

Cairo, New Cairo, Egypt

Location

Study Officials

• Mohamed Shawky, BDS

  The British University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the differences in techniques, the operating surgeon can not be blinded to the procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist (BDS)

Model Details: Two equal parallel groups with a 1:1 allocation ratio to receive either vestibular socket therapy (test group) or to be treated with conventional mucoperiosteal flap (control group).

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: March 22, 2024
• Study Start: October 23, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

EG (1)