Clinical trial NCT04332185: Vestibular Socket Therapy in Compromised Sockets
Official title: Vestibular Socket Therapy With Immediate Implant Placement for Managing Compromised Fresh Extraction Sockets: A Prospective Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Reaction
Keywords: Vestibular socket therapy
bone grafting
immediate implant placement
socket preservation
bone shielding
cortical bone shield
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: (VST) included the following steps. a-traumatic tooth extractio. One-cm long vestibular access incision was made 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 . implant was placed. A flexible cortical membrane shield that is made of cortical bone of heterologous origin of 0.6 mm thickness was introduced from the vestibular access incision reaching 1 mm below the socket orifice through the tunnel then stabilized using a micro screw to the alveolar bone. The socket gap between the implant and the shield was then packed thoroughly with particulate bone graft. 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 1 and 2 years using CBCT.
Primary purpose: TREATMENT

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.

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
* smokers
* systemic condition

Primary outcomes:
measure: bone thickness
timeFrame: 2 years
Secondary outcomes:
measure: Bone height
timeFrame: 2 years
measure: pocket depth
timeFrame: 1.5 year
measure: PES
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: ElAskary and Associates Private clinic
Study officials:
affiliation: Private Practice
name: AbdelSalam T ElAskary, Dr, BDS
role: STUDY_DIRECTOR
References: