Vestibular Versus Trapezoid Flap in Immediate Implants

Official title

The Impact of Vestibular Versus Trapezoidal Flap Design on Immediate Implants : a Randomized Clinical Trial

Overview

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 \[6-8\].

Detailed description

The concept of promptly replacing teeth using dental implants was introduced many years ago as a way to reduce the time between tooth extraction and the completion of prosthetic restoration. However, immediate implant placement was not recommended by many authors such as Buser D, and Yong , due to the lack of buccal bone, presence of infection, and the continuing post extraction bone remodeling that occurs along both buccal and lingual plates walls of the socket.It has been proposed that the subsequent resorption of the socket walls after tooth extraction should be taken into account when developing any future treatment plan. Furthermore, the labial plate of bone is already compromised in type II extraction socket and is indicated for guided bone regeneration (GBR) such as early placement protocol, using the contour augmentation procedure. Many authors have conducted immediate implant placement using the conventional immediate implant placement via reflecting a mucoperiosteal flap that enabled the accurate socket debridement , total visibility of the socket environment and the ability to graft the buccal osseous defect.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 \[10\]. Typically, this procedure is performed on defects that are equal to or greater than 2 mm in size, such as dehiscence or fenestration defects. Tension-free primary closure will then achieved either on a cover screw or a healing abutment, several flap designs were proposed to minimize the deleterious effect of the classic approach such as papilla preservative incision and buccal esthetic flaps technique.

Interventions

• Procedure control GBR
  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 VST
  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.

Primary outcome measures

• Changes in mid facial recession [Time frame: 6 months after final restoration]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Egypt · 3 centers

• The British university in Egypt — Cairo
• Faculty of oral and dental medicine the british university in egypt elsherouk — Cairo
• Faculty of oral and dental medicine the british university in egypt elsherouk — Cairo

Identifiers

NCT: NCT07115758 · 24-093

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗