Dental Implant FailedVSTNCT04787237
Vetsibular Socket Therapy Versus Buser's Technique
A study testing VST and immediate implants and Buser technique and early implants placement in people with Dental Implant Failed, run by Cairo University at 2 sites in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- VST and immediate implants and Buser technique and early implants placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Jan 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
ElAskary and Associates Private clinic
Alexandria
Faculty of dentistry
Cairo, Manial, 12911
About this study
Official title: Immediate Implant Placement Using Vestibular Socket Therapy Versus Early Implant Placement Using Buser's Technique for Managing Type 2 Extraction Sockets: A Randomized Clinical Trial
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
Read the 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
- Being tested
- VST and immediate implants, Buser technique and early implants placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VST and immediate implantsOther
Also called VST
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 technique and early implants placementOther
Also called contour augmentation 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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Buser technique and early implants placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: crown delivery and 1 year
Secondary outcomes (2)
labial plate thickness changes
Changes in the thickness of the labial plate of bone was measured by superimposing CBCT images obtained at the baseline (time of tooth extraction) and those after 12 months.
Measured: implant insertion -1 year
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.
Measured: Implant insertion- 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Jan 2019
- Primary completion31 Aug 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial, blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc.
- Responsible party
- Principal investigator, Iman Abd-ElWahab Radi, PhD, Cairo University
- Investigators
- Iman Radi, PhD, Study director, Cairo UniversityAbdelSalam Alaskary, BDS, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787237
- Sponsor's protocol ID
- 0010558
- Acronym
- VST
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2021
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement Using Vestibular Socket Therapy Versus Early Implant Placement Using Buser's Technique for Managing Type 2 Extraction Sockets: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04787237
- Acronym / sponsor ID
- VST / 0010558
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial, blinded
| Arm | Type | Receives |
|---|---|---|
| Vestibulart socket therapy and immediate implants | Experimental | Other: VST and immediate implantsA 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 |
| Buser's technique and early implant placement | Active comparator | Other: Buser technique and early implants placementIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VST and immediate implantsAlso: VSTOne-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 | Other | Vestibulart socket therapy and immediate implants |
| Buser technique and early implants placementAlso: contour augmentation and early implant placementIn 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. | Other | Buser's technique and early implant placement |
Primary outcome
vertical and horizontal soft tissue changes
Time frame: crown delivery and 1 year
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.
2 secondary outcomes
labial plate thickness changes
Time frame: implant insertion -1 year
implant survival
Time frame: Implant insertion- 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman Radi, PhD study director
Cairo University
AbdelSalam Alaskary, BDS principal investigator
Private Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VST and immediate implants and Buser technique and early implants placement in people with Dental Implant Failed, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical and horizontal soft tissue changes (time frame: crown delivery and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.