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Clinical Trials/NCT04787224
NCT04787224
Completed
Not Applicable

Soft and Hard Tissue Evaluation for Vestibular Socket Therapy of Immediately Placed Implants in Infected and Non-infected Sockets: A 1-year Prospective Cohort Study

Cairo University2 sites in 1 country26 target enrollmentJanuary 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant Site Infection
Sponsor
Cairo University
Enrollment
26
Locations
2
Primary Endpoint
implant survival
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Vestibular socket therapy with immediate implant placement is compared in infected and non-infected sockets regarding implant survival, bone thickness and soft tissue height .

Detailed Description

For non infected sockets, a 15c blade (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) was used to cut a 1-cm long vestibular access incision , 3-4 mm apical to the mucogingival junction of the involved tooth. The socket orifice and the vestibular access incision were connected by a subperiosteal tunnel that was created using a periotome and a micro-periosteal elevator (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany). Implants, (Biohorizons, Birmingham, Al, USA) , were installed using a 3D printed surgical guide (Surgical Guide Resin, Form 2, Formlabs). A flexible cortical membrane shield (OsteoBiol® Lamina, Tecnoss®, Torino, Italy) of heterologous origin, 0.6 mm in thickness was prepared by hydrating and trimming it. It was then tucked through the vestibular access incision, till it extended 1 mm below the socket orifice, and stabilized using a membrane tack (AutoTac System Kit, Biohorizons Implant Systems, Birmingham, Alabama Inc, USA) to the apical bone. The gap between the implant and the shield/the labial plate was then filled with particulate bone graft \[75% autogenous bone chips harvested form local surgical sites and 25% inorganic bovine bone mineral matrix (MinerOss X , Biohorizons, Birmingham, Al, USA)\]. For the infected sockets, the 6-day protocol was implemented. Atraumatic extraction of the infected tooth by the periotome was followed by curettage, mechanical debridement and chemical irrigation using metronidazole irrigation solution (500mg/100ml, Amrizole, Amria Pharma, Alexandria, Egypt). The root of the involved tooth was cleaned with an ultrasonic cleaner, cut to its apical third, reimplanted into the socket and maintained there for 6 days by bonding its crown to the adjacent teeth using composite resin. Implant and crown placement were done as described above for the non-infected socket group.

Registry
clinicaltrials.gov
Start Date
January 15, 2019
End Date
January 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Iman Abd-ElWahab Radi, PhD

Professor

Cairo University

Eligibility Criteria

Inclusion Criteria

  • all patients were adults ≥ 18 years,
  • 1-5 non-adjacent hopeless maxillary teeth in the esthetic zone.
  • The involved teeth had type II sockets.
  • To achieve optimum primary stability for the implants (30Ncm insertion torque), adequate palatal and at least 3 mm apical bone should be available to engage the immediately placed implants.

Exclusion Criteria

  • Smoking and/or pregnant patients
  • systemic diseases
  • a history of chemo- or radiotherapy within the past 2 years were excluded.

Outcomes

Primary Outcomes

implant survival

Time Frame: implant insertion- 1 year

Implant survival was reported as defined by Buser et al by the absence of peri-implant infection, persistent subjective complaints such as pain, foreign body sensation, and/or dysesthesia, radiolucency around the implant, and/or any detectable implant mobility.

Secondary Outcomes

  • mucosal recession(crown insertion- 1 year)
  • labial plate thickness changes(implant insertion- 1 year)

Study Sites (2)

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