Vestibular Socket Therapy (VST) in Infected and Non Infected Sockets

NCT04787224 | Completed DMC

• 1 other identifier: 0010557
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

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 .

Conditions

Implant Site Infection

Outcome Measures

Primary Outcomes (1)

• implant survival

  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.

  implant insertion- 1 year

Secondary Outcomes (2)

• mucosal recession

  crown insertion- 1 year

• labial plate thickness changes

  implant insertion- 1 year

Study Arms (2)

infected sockets

Signs of infection were periapical radiolucency only in 3 sites (2 patients), fistula in 2 sites (2 patients), sinus in 11 sites (7 patients) and finally swelling in 3 sites (2 patients)

Other: immediate implant with vestibular socket therapy

Non infected sockets

This is ensured by the absence of any clinical signs and symptoms of infection in addition to negative radiographic findings

Other: immediate implant with vestibular socket therapy

Interventions

immediate implant with vestibular socket therapy OTHER

A 1-cm long vestibular access incision was cut, 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. Implants were installed using a CADLCAM surgical guide. A flexible cortical membrane shield 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 ( 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.

Also known as: VST

Non infected sockets; infected sockets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with fresh extraction sockets in the esthetic zone

You may qualify if:

• all patients were adults ≥ 18 years,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• BioHorizons, Inc.: collaborator

Study Sites (2)

Faculty of dentistry

Cairo, Manial, 12911, Egypt

Location

ElAskary and Associates Private clinic

Alexandria, Egypt

Location

Related Publications (1)

• Elaskary A, Thabet A, Hussin M, Radi IA. 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. BMC Oral Health. 2024 Oct 7;24(1):1190. doi: 10.1186/s12903-024-04905-3.

  PMID: 39375634 DERIVED

Study Officials

• Iman Radi, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• AbdelSalam Alaskary, BDS

  Private Practice

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: January 15, 2019
• Primary Completion: November 15, 2020
• Study Completion: January 30, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)