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Clinical Trials/NCT04332185
NCT04332185
Completed
Not Applicable

Vestibular Socket Therapy With Immediate Implant Placement for Managing Compromised Fresh Extraction Sockets: A Prospective Single Arm Clinical Trial

Cairo University1 site in 1 country20 target enrollmentJanuary 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant Site Reaction
Sponsor
Cairo University
Enrollment
20
Locations
1
Primary Endpoint
bone thickness
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Twenty compromised post-extraction sockets were managed by VST and IMP. After tooth extraction and IMP, a vestibular incision was cut and a cortical bone shield was stabilized. The jumping gap was then filled with particulate bone graft, which was protected by a healing abutment. After 2 years labial plate thickness was evaluated at 3 levels (crestal, middle and apical) using cone beam computed tomography (CBCT). Pink esthetic core (PES), and probing depth (PD) were also measured. 2 year following implant placement, the mean differences (µ) and standard deviations (SD) were calculated. Paired t-test was used for detecting significant results at P≤.05.

Detailed Description

In this protocol, atraumatic tooth extraction was carried out using periotomes (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) under local anaesthesia (ARTINIBSA 4% 1:100.000. Inibsa Dental S.L.U. Barcelona, SPAIN). After that, the socket was thoroughly curetted and debrided and repeatedly irrigated with 100 ml of anti-anaerobic infusion solution of 500 mg Metronidazole (Minapharm pharmaceuticals, Egypt). The root was then trimmed to half-length, its surface cleansed with an ultrasonic cleaner , and reinserted into the socket with its crown bonded to adjacent teeth . After six days, the root was removed and VST protocol was implemented. Vestibular socket therapy (VST) included the following steps. a-traumatic tooth extraction, the socket curetted and rinsed with normal saline thoroughly (Figure 2 a,b). One-cm long vestibular access incision was made using a 15c blade (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) 3-4 mm apical to the mucogingival junction at the related socket (. A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision using periotomes and micro periosteal elevators (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) . A prefabricated CAD CAM surgical guide was used to deliver the implant fixture (Biohorizons, Birmingham, Al, USA) to its pre-planned location 3-4 mm apical to socket base with adequate primary stability achieved using a torque wrench reaching 30 Ncm torque (Figure 2 g). A flexible cortical membrane shield that is made of cortical bone of heterologous origin of 0.6 mm thickness (OsteoBiol® Lamina , Tecnoss®, Torino, Italy) was hydrated and then trimmed and introduced from the vestibular access incision reaching 1 mm below the socket orifice through the tunnel then stabilized using a membrane tack or a micro screw to the alveolar bone apical to the base of the socket (AutoTac System Kit, Biohorizons Implant Systems, Birmingham , Alabama Inc, USA) . The socket gap between the implant and the shield was then packed thoroughly with particulate bone graft (75% autogenous bone chips and 25% deproteinized bovine bone mineral (DBBM) of equine origin, fully enzyme deantigenised (Bio-Gen Mix, Bioteck, Vicenza -Italy). For patients exhibiting thin soft tissue phenotype (assessed using the probe transparency method) a subepithelial connective tissue graft was harvested using a single incision technique (Hürzeler MB \& Weng D 1999) from the palate which and secured to the inner surface of the soft tissue tunnel wall with sutures. Finally, the vestibular incision was secured with 6/0 nylon sutures (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) . A chairside-fabricated anatomical healing abutment was used to seal the socket orifice . restorative phase then took place 45 days post-surgery till the final restoration finally cemented at 2 months post-surgery and followed up for 2 years using CBCT.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
February 28, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Iman Abd-ElWahab Radi, PhD

Professor

Cairo University

Eligibility Criteria

Inclusion Criteria

  • unrestorable maxillary anterior teeth
  • with adequate palatal and apical bone that allows achieving adequate implant primary stability
  • compromised sockets

Exclusion Criteria

  • infection
  • systemic condition

Outcomes

Primary Outcomes

bone thickness

Time Frame: 2 years

continuous outcome

Secondary Outcomes

  • Bone height(2 years)
  • pocket depth(1.5 year)
  • PES(1.5 year)

Study Sites (1)

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