Implant Site InfectionVSTNCT04787224
Vestibular Socket Therapy (VST) in Infected and Non Infected Sockets
An observational study of Implant Site Infection, run by Cairo University at 2 sites in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant Site Infection
- What is being tested?
- immediate implant with vestibular socket therapy
- How many people
- 26 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jan 2019to 30 Jan 2021
- Phase
- Observational
- 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
Study population: Participants with fresh extraction sockets in the esthetic zone
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.
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: 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
Vestibular socket therapy with immediate implant placement is compared in infected and non-infected sockets regarding implant survival, bone thickness and soft tissue height .
Read the detailed description
For non infected sockets, a 15c blade (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) was used to cut a 1-cm long vestibular access incision , 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 (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany). Implants, (Biohorizons, Birmingham, Al, USA) , were installed using a 3D printed surgical guide (Surgical Guide Resin, Form 2, Formlabs). A flexible cortical membrane shield (OsteoBiol® Lamina, Tecnoss®, Torino, Italy) 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 (AutoTac System Kit, Biohorizons Implant Systems, Birmingham, Alabama Inc, USA) 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 (MinerOss X , Biohorizons, Birmingham, Al, USA)]. For the infected sockets, the 6-day protocol was implemented. Atraumatic extraction of the infected tooth by the periotome was followed by curettage, mechanical debridement and chemical irrigation using metronidazole irrigation solution (500mg/100ml, Amrizole, Amria Pharma, Alexandria, Egypt). The root of the involved tooth was cleaned with an ultrasonic cleaner, cut to its apical third, reimplanted into the socket and maintained there for 6 days by bonding its crown to the adjacent teeth using composite resin. Implant and crown placement were done as described above for the non-infected socket group.
- Conditions
- Implant Site Infection
- Being tested
- immediate implant with vestibular socket therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant with vestibular socket therapyOther
Also called VST
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: immediate implant with vestibular socket therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (2)
mucosal recession
Amount of mucosal recession was 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 insertion- 1 year
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
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 start15 Jan 2019
- Primary completion15 Nov 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant Site InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 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, Principal investigator, Cairo UniversityAbdelSalam Alaskary, BDS, Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787224
- Sponsor's protocol ID
- 0010557
- Acronym
- VST
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39375634
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04787224
- Acronym / sponsor ID
- VST / 0010557
- Conditions
- Implant Site Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 30 Jan 2021 (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.
Vestibular socket therapy with immediate implant placement is compared in infected and non-infected sockets regarding implant survival, bone thickness and soft tissue height .
Detailed description
For non infected sockets, a 15c blade (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) was used to cut a 1-cm long vestibular access incision , 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 (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany). Implants, (Biohorizons, Birmingham, Al, USA) , were installed using a 3D printed surgical guide (Surgical Guide Resin, Form 2, Formlabs). A flexible cortical membrane shield (OsteoBiol® Lamina, Tecnoss®, Torino, Italy) 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 (AutoTac System Kit, Biohorizons Implant Systems, Birmingham, Alabama Inc, USA) 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 (MinerOss X , Biohorizons, Birmingham, Al, USA)]. For the infected sockets, the 6-day protocol was implemented. Atraumatic extraction of the infected tooth by the periotome was followed by curettage, mechanical debridement and chemical irrigation using metronidazole irrigation solution (500mg/100ml, Amrizole, Amria Pharma, Alexandria, Egypt). The root of the involved tooth was cleaned with an ultrasonic cleaner, cut to its apical third, reimplanted into the socket and maintained there for 6 days by bonding its crown to the adjacent teeth using composite resin. Implant and crown placement were done as described above for the non-infected socket group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infected sockets | – | Other: immediate implant with vestibular socket therapySigns 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) |
| Non infected sockets | – | Other: immediate implant with vestibular socket therapyThis is ensured by the absence of any clinical signs and symptoms of infection in addition to negative radiographic findings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with fresh extraction sockets in the esthetic zone
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 (3 listed)
- Smoking and/or pregnant patients
- systemic diseases
- a history of chemo- or radiotherapy within the past 2 years were 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 |
|---|---|---|
| immediate implant with vestibular socket therapyAlso: VSTA 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. | Other | Non infected sockets, infected sockets |
Primary outcome
implant survival
Time frame: implant insertion- 1 year
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.
2 secondary outcomes
mucosal recession
Time frame: crown insertion- 1 year
labial plate thickness changes
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 10 Mar 2021.
- Derived from this study: PubMed 39375634Elaskary 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.
- 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 principal investigator
Cairo University
AbdelSalam Alaskary, BDS study director
Private Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Site Infection, 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 3 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 10 Mar 2021. 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?
implant survival (time frame: implant insertion- 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787224, which also lists 1 linked publication.
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 10 Mar 2021.