Vetsibular Socket Therapy Versus Buser's Technique

NCT ID: NCT04787237

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2020-10-31

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

Detailed Description

Preoperative procedures A preoperative radiograph was performed for all patients for diagnosis and treatment planning purposes. Non-surgical periodontal treatment was done as needed. Impressions were taken and casted in stone for the fabrication of the surgical templates.

Surgical protocol As dictated by the randomization patients were assigned to either Buser's technique or to the VST. In the VST group, 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).

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 (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). Implant fixture (Biohorizons, Birmingham, Al, USA) 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 (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).

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. A slightly palatal incision in the edentulous area is done, with the incision made along the inner surface of the palatal bone wall deep into the socket allowing the entire regenerated soft tissue to be part of the buccal flap. After preparing the implant bed, the site was irrigated using normal saline. Implant was then placed under the crest of the palatal bone. A healing abutment was then attached.The bone graft was placed in a layered manner, where the cortical bone chips were placed first followed by the bio-oss activated mix. 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.

Conditions

Dental Implant Failed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vestibulart socket therapy and immediate implants

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

Group Type: EXPERIMENTAL

VST and immediate implants

Intervention Type: 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

Buser's technique and early implant placement

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.

Group Type: ACTIVE_COMPARATOR

Buser technique and early implants placement

Intervention Type: 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.

Interventions

VST and immediate implants

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

Intervention Type: OTHER

Buser technique and early implants placement

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.

Intervention Type: OTHER

Other Intervention Names

VST; contour augmentation and early implant placement

Eligibility Criteria

Inclusion Criteria

• all patients were adults ≥ 18 years
• 1-5 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioHorizons, Inc.

INDUSTRY

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Iman Abd-ElWahab Radi, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iman Radi, PhD

Role: STUDY_DIRECTOR

Cairo University

AbdelSalam Alaskary, BDS

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

Faculty of dentistry

Cairo, Manial, Egypt

ElAskary and Associates Private clinic

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0010558

Identifier Type: -

Identifier Source: org_study_id