Vestibular Versus Trapezoid Flap in Immediate Implants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBritish University In Egypt

About this trial

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 \[6-8\].

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • control GBR

    Procedure/Surgery

    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.

  • VST

    Procedure/Surgery

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: VSTExperimental treatment 2 interventions
Group B: GBRActive comparator 2 interventions

Trial outcomes

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

Time frame
6 months after final restoration

Secondary outcomes

Other outcomes

Sponsors and contacts

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