Vestibular Versus Trapezoid Flap in Immediate Implants

NCT07115758 | Not Yet Recruiting

• 1 other identifier: 24-093
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The vestibular socket therapy was introduced by Elaskary et al that allowed immediate implant placement and total socket rehabilitation at the same time in class 2 compromised sockets , that showed supreme esthetic and functional predictability over 1,2,3 years of follow up, and showed minimal or no post restorative mid facial recession . The Vestibular socket therapy (VST) entails socket augmentation through a minimally invasive vestibular access incision to allow the delivery of the grafting components thus bypass the deleterious effect of the classic mucoperiosteal flap reflection as well as the deleterious effect of the delay approach, regardless of the degree of socket compromise \[6-8\].

Conditions

Immediate Dental Implant Placement; Defect in Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• Changes in mid facial recession

  soft tissue stability measured in mm as difference In mid facial recession between pre operative and six months post operative

  6 months after final restoration

Study Arms (2)

VST

EXPERIMENTAL

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: control GBR; Procedure: VST

GBR

ACTIVE COMPARATOR

will have a full thickness papilla preservation 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: control GBR; Procedure: VST

Interventions

control GBR PROCEDURE

will have a full thickness papilla preservation 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.

GBR; VST

VST PROCEDURE

Pre extraction procedure: Prior to tooth extraction, cone beam computed tomography (CBCT) images will be taken to inspect the overall socket condition. All patients will be scanned pre-operatively using an intra-oral scanner (IOS). Extraction protocol: incisal extraction technique, where atraumatic tooth extraction to the hopeless tooth will be performed using periotomes followed by conventional forceps.

GBR; VST

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having a 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, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.

You may not qualify if:

• Smokers, pregnant women, patients with systemic diseases, and history of chemotherapy or radiotherapy within the past 2 years.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (3)

The British university in Egypt

Cairo, New Cairo, Egypt

Location

Faculty of oral and dental medicine the british university in egypt elsherouk

Cairo, Egypt

Location

Faculty of oral and dental medicine the british university in egypt elsherouk

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To address the labial plate of bone defect, a conventional mucoperiosteal flap will be utilized along with guided bone regeneration (GBR). GBR is a surgical technique that involves the use of bone grafts and barrier membranes to reconstruct buccal osseous defects around dental implants

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)