Implant Site ReactionNCT04332185
Vestibular Socket Therapy in Compromised Sockets
A study testing vestibular socket therapy in people with Implant Site Reaction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- vestibular socket therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 28 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unrestorable maxillary anterior teeth
- with adequate palatal and apical bone that allows achieving adequate implant primary stability
- compromised sockets
Who cannot join
- infection
- smokers
- systemic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular Socket Therapy With Immediate Implant Placement for Managing Compromised Fresh Extraction Sockets: A Prospective Single Arm Clinical Trial
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.
Read the detailed description
In this protocol, 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). After that, the socket was thoroughly curetted and debrided and repeatedly irrigated with 100 ml of anti-anaerobic infusion solution of 500 mg Metronidazole (Minapharm pharmaceuticals, Egypt). The root was then trimmed to half-length, its surface cleansed with an ultrasonic cleaner , and reinserted into the socket with its crown bonded to adjacent teeth . After six days, the root was removed and VST protocol was implemented.
Vestibular socket therapy (VST) included the following steps. a-traumatic tooth extraction, the socket curetted and rinsed with normal saline thoroughly (Figure 2 a,b). 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) . A prefabricated CAD CAM surgical guide was used to deliver the implant fixture (Biohorizons, Birmingham, Al, USA) 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 (Figure 2 g). 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) of equine origin, fully enzyme deantigenised (Bio-Gen Mix, Bioteck, Vicenza -Italy).
For patients exhibiting thin soft tissue phenotype (assessed using the probe transparency method) a subepithelial connective tissue graft was harvested using a single incision technique (Hürzeler MB \& Weng D 1999) from the palate which and secured to the inner surface of the soft tissue tunnel wall with sutures. Finally, the vestibular incision was secured with 6/0 nylon sutures (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) . 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 2 years using CBCT.
- Conditions
- Implant Site Reaction
- Being tested
- vestibular socket therapy
- Keywords
- Vestibular socket therapy, bone grafting, immediate implant placement, socket preservation, bone shielding, cortical bone shield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular socket therapyProcedure or surgery
(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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Procedure: vestibular socket therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone thickness
continuous outcome
Measured: 2 years
Secondary outcomes (3)
Bone height
continuous outcome
Measured: 2 years
pocket depth
continuous outcome
Measured: 1.5 year
PES
ordinal outcome
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start15 Jan 2018
- Primary completion12 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- (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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Abd-ElWahab Radi, PhD, Cairo University
- Investigators
- AbdelSalam T ElAskary, Dr, BDS, Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332185
- Sponsor's protocol ID
- 0010556
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Socket Therapy With Immediate Implant Placement for Managing Compromised Fresh Extraction Sockets: A Prospective Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04332185
- Acronym / sponsor ID
- 0010556
- Conditions
- Implant Site Reaction
- Keywords
- Vestibular socket therapy, bone grafting, immediate implant placement, socket preservation, bone shielding, cortical bone shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 2 Apr 2020 (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.
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.
Detailed description
In this protocol, 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). After that, the socket was thoroughly curetted and debrided and repeatedly irrigated with 100 ml of anti-anaerobic infusion solution of 500 mg Metronidazole (Minapharm pharmaceuticals, Egypt). The root was then trimmed to half-length, its surface cleansed with an ultrasonic cleaner , and reinserted into the socket with its crown bonded to adjacent teeth . After six days, the root was removed and VST protocol was implemented.
Vestibular socket therapy (VST) included the following steps. a-traumatic tooth extraction, the socket curetted and rinsed with normal saline thoroughly (Figure 2 a,b). 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) . A prefabricated CAD CAM surgical guide was used to deliver the implant fixture (Biohorizons, Birmingham, Al, USA) 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 (Figure 2 g). 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) of equine origin, fully enzyme deantigenised (Bio-Gen Mix, Bioteck, Vicenza -Italy).
For patients exhibiting thin soft tissue phenotype (assessed using the probe transparency method) a subepithelial connective tissue graft was harvested using a single incision technique (Hürzeler MB \& Weng D 1999) from the palate which and secured to the inner surface of the soft tissue tunnel wall with sutures. Finally, the vestibular incision was secured with 6/0 nylon sutures (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany) . 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 2 years using CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- (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.
| Arm | Type | Receives |
|---|---|---|
| Vestibulart socket therapy | Experimental | Procedure: 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 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unrestorable maxillary anterior teeth
- with adequate palatal and apical bone that allows achieving adequate implant primary stability
- compromised sockets
Key exclusion criteria (3 listed)
- infection
- smokers
- systemic condition
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 |
|---|---|---|
| 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 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 or surgery | Vestibulart socket therapy |
Primary outcome
bone thickness
Time frame: 2 years
continuous outcome
3 secondary outcomes
Bone height
Time frame: 2 years
pocket depth
Time frame: 1.5 year
PES
Time frame: 1.5 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 17 Apr 2020.
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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.
AbdelSalam T ElAskary, Dr, BDS study director
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular socket therapy in people with Implant Site Reaction, run by Cairo University at 1 site 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 3 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
bone thickness (time frame: 2 years). 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 17 Apr 2020.