Vestibular Socket Therapy in Compromised Sockets

Implant Site Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332185
• Other study ID #: 0010556
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2020
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implant Site Reaction

Intervention

Procedure:
• vestibular socket therapy
(VST) included the following steps. a-traumatic tooth extraction, the socket curetted and rinsed with normal saline thoroughly . One-cm long vestibular access incision was made using a 15c blade 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 A flexible cortical membrane shield that is made of cortical bone of heterologous origin of 0.6 mm thickness 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 micro screw to the alveolar bone apical to the base of the socket .

Locations

Country	Name	City	State
Egypt	ElAskary and Associates Private clinic	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone thickness	continuous outcome	2 years
Secondary	Bone height	continuous outcome	2 years
Secondary	pocket depth	continuous outcome	1.5 year
Secondary	PES	ordinal outcome	1.5 year