Clinical trial NCT04787224: Vestibular Socket Therapy (VST) in Infected and Non Infected Sockets
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Site Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2021-03-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with fresh extraction sockets in the esthetic zone

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.

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.

Primary outcomes:
measure: implant survival
timeFrame: implant insertion- 1 year
Secondary outcomes:
measure: mucosal recession
timeFrame: crown insertion- 1 year
measure: labial plate thickness changes
timeFrame: implant insertion- 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
state: Manial
city: Alexandria
country: Egypt
facility: ElAskary and Associates Private clinic
Study officials:
affiliation: Cairo University
name: Iman Radi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice
name: AbdelSalam Alaskary, BDS
role: STUDY_DIRECTOR
References: