Vestibular Socket Therapy in Compromised Sockets

NCT04332185 | Completed

• 1 other identifier: 0010556
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Site Reaction

Keywords

Vestibular socket therapy; bone grafting; immediate implant placement; socket preservation; bone shielding; cortical bone shield

Outcome Measures

Primary Outcomes (1)

• bone thickness

  continuous outcome

  2 years

Secondary Outcomes (3)

• Bone height

  2 years

• pocket depth

  1.5 year

• PES

  1.5 year

Study Arms (1)

Vestibulart socket therapy

EXPERIMENTAL

(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 .

Procedure: vestibular socket therapy

Interventions

vestibular socket therapy PROCEDURE

(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 .

Vestibulart socket therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unrestorable maxillary anterior teeth
• with adequate palatal and apical bone that allows achieving adequate implant primary stability
• compromised sockets

You may not qualify if:

• infection
• smokers
• systemic condition

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

ElAskary and Associates Private clinic

Alexandria, Egypt

Location

Study Officials

• AbdelSalam T ElAskary, Dr, BDS

  Private Practice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: (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.

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: January 15, 2018
• Primary Completion: January 12, 2020
• Study Completion: February 28, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

EG (1)