Vetsibular Socket Therapy Versus Buser's Technique

NCT04787237 | Completed DMC

• 1 other identifier: 0010558
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

immediate implant placement using the VST was compared to early implant placement protocol using Buser's technique regarding implant survival, changes in labial plate thickness and soft tissue height after 1 year of implant placement

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• vertical and horizontal soft tissue changes

  Amount of soft tissue changes were identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL files of the models, obtained via intra-oral scanning, at the baseline (of the unrestorable tooth) with those after 12 months of implant insertion. The 3D software roughly aligned of both pre-and postoperative models through 3 identical points, identified on their surfaces. The best-fit algorithm of the software then perfected the superimposition process. The superimposed models were then imported into an STL viewer, where the measurements were performed. This method was proven to be accurate in volumetric measurements of hard and soft tissues.

  crown delivery and 1 year

Secondary Outcomes (2)

• labial plate thickness changes

  implant insertion -1 year

• implant survival

  Implant insertion- 1 year

Study Arms (2)

Vestibulart socket therapy and immediate implants

EXPERIMENTAL

A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision using periotomes and micro periosteal elevators (. Implant fixture were then inserted . A flexible cortical membrane shield that is made of cortical bone of heterologous origin was 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 . The socket gap between the implant and the shield was then packed thoroughly with particulate bone graft

Other: VST and immediate implants

Buser's technique and early implant placement

ACTIVE COMPARATOR

In Buser's group early implant placement, the failing tooth was extracted atraumatically using a periotome. A collagen plug was placed to stabilize the wound clot. A healing period of 4-8 weeks was followed. Then an open flap implant surgery using a triangular flap design was cut. Implant was then placed under the crest of the palatal bone. A healing abutment was then attached. Contour augmentation was done using autogenous bone chips mixed with saline and bone conditioned medium (BCM) added to bioss bone granules to activate it.

Other: Buser technique and early implants placement

Interventions

VST and immediate implants OTHER

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 (. Implant fixture were then inserted after drilling 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 . 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 . The socket gap between the implant and the shield was then packed thoroughly with particulate bone graft

Also known as: VST

Vestibulart socket therapy and immediate implants

Buser technique and early implants placement OTHER

In Buser's group early implant placement, the failing tooth was extracted atraumatically using a periotome. A collagen plug was placed to stabilize the wound clot. A healing period of 4-8 weeks (depending on the size of the extracted tooth) was followed. Then an open flap implant surgery using a triangular flap design was cut. After preparing the implant bed, the site was irrigated using normal saline. A healing abutment was then attached. Contour augmentation was done using autogenous bone chips mixed with saline and bone. A non-cross liked membrane was then placed, after being soaked with BCM. Finally, the healing abutment was removed and the flap was released to allow for its suturing.

Also known as: contour augmentation and early implant placement

Buser's technique and early implant placement

Eligibility Criteria

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

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.
• Infected sockets were also 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

Study Officials

• Iman Radi, PhD

  Cairo University

  STUDY DIRECTOR

• AbdelSalam Alaskary, BDS

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: AE and IR were responsible for measuring the outcomes and they were blinded to the treatments, since they were not involved in the treatment The statistician was also blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized clinical trial, blinded

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: January 30, 2019
• Primary Completion: August 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)