Immediate Dental Implant PlacementVSTNCT07115758
Vestibular Versus Trapezoid Flap in Immediate Implants
A study testing VST in people with Immediate Dental Implant Placement and Defect in Alveolar Ridge, run by British University In Egypt at 3 sites in Egypt.
Trial summary
The vestibular socket therapy was introduced by Elaskary et al that allowed immediate implant placement and total socket rehabilitation at the same time in class 2 compromised sockets , that showed supreme esthetic and functional predictability over 1,2,3 years of follow up, and showed minimal or no post restorative… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Placement, Defect in Alveolar Ridge
- What is being tested?
- VST
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesEgypt
- Study dates
- 15 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having a hopeless maxillary tooth in the esthetic region missing coronal tooth structure, type II socket (deficient labial plate of bone and intact overlying soft tissues), adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.
Who cannot join
- Smokers, pregnant women, patients with systemic diseases, and history of chemotherapy or radiotherapy within the past 2 years.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites
The British university in Egypt
Cairo, New Cairo
Faculty of oral and dental medicine the british university in egypt elsherouk
Cairo
Alhassan Diab, phd, 020201003642191, alhassan.diab@bue.edu.eg
Mohamed Shawky, B.D.S
Faculty of oral and dental medicine the british university in egypt elsherouk
Cairo
About this study
Official title: The Impact of Vestibular Versus Trapezoidal Flap Design on Immediate Implants : a Randomized Clinical Trial
The vestibular socket therapy was introduced by Elaskary et al that allowed immediate implant placement and total socket rehabilitation at the same time in class 2 compromised sockets , that showed supreme esthetic and functional predictability over 1,2,3 years of follow up, and showed minimal or no post restorative mid facial recession . The Vestibular socket therapy (VST) entails socket augmentation through a minimally invasive vestibular access incision to allow the delivery of the grafting components thus bypass the deleterious effect of the classic mucoperiosteal flap reflection as well as the deleterious effect of the delay approach, regardless of the degree of socket compromise [6-8].
Read the detailed description
The concept of promptly replacing teeth using dental implants was introduced many years ago as a way to reduce the time between tooth extraction and the completion of prosthetic restoration. However, immediate implant placement was not recommended by many authors such as Buser D, and Yong , due to the lack of buccal bone, presence of infection, and the continuing post extraction bone remodeling that occurs along both buccal and lingual plates walls of the socket.It has been proposed that the subsequent resorption of the socket walls after tooth extraction should be taken into account when developing any future treatment plan. Furthermore, the labial plate of bone is already compromised in type II extraction socket and is indicated for guided bone regeneration (GBR) such as early placement protocol, using the contour augmentation procedure. Many authors have conducted immediate implant placement using the conventional immediate implant placement via reflecting a mucoperiosteal flap that enabled the accurate socket debridement , total visibility of the socket environment and the ability to graft the buccal osseous defect.To address the labial plate of bone defect, a conventional mucoperiosteal flap will be utilized along with guided bone regeneration (GBR). GBR is a surgical technique that involves the use of bone grafts and barrier membranes to reconstruct buccal osseous defects around dental implants [10]. Typically, this procedure is performed on defects that are equal to or greater than 2 mm in size, such as dehiscence or fenestration defects. Tension-free primary closure will then achieved either on a cover screw or a healing abutment, several flap designs were proposed to minimize the deleterious effect of the classic approach such as papilla preservative incision and buccal esthetic flaps technique.
- Being tested
- control GBR, VST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control GBRProcedure or surgery
will have a full thickness papilla preservation FLAP, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position.
VSTProcedure or surgery
Pre extraction procedure:
Prior to tooth extraction, cone beam computed tomography (CBCT) images will be taken to inspect the overall socket condition.
All patients will be scanned pre-operatively using an intra-oral scanner (IOS).
Extraction protocol:
incisal extraction technique, where atraumatic tooth extraction to the hopeless tooth will be performed using periotomes followed by conventional forceps.
| Study group | Role | What they receive |
|---|---|---|
| VST | Experimental | Elaskary Vestibular socket therapy instruments will be used for the intervention, A 1 cm long vestibular access incision at the allocated hopeless tooth will be made at the base of the hopeless tooth to the adjacent teeth. The vestibular pouch will then be dissected in an incisal direction exposing the total socket area and allowing direct access to the socket environment. An immediate implant will be installed using a surgical guide. A membrane shield 1 mm thick will be, trimmed, and tucked through the vestibular access incision starting at 1 mm beyond the socket orifice and reaching to the apical area of the socket. The gap and/ or the defect between the implant body and the shield will then be filled with the same grafting components so the control group. Finally, the vestibular incision will be secured with sutures. The socket will be sealed with a customized healing abutment. Receives: Procedure: control GBR; Procedure: VST |
| GBR | Active comparator | will have a full thickness papilla preservation FLAP, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position. Receives: Procedure: control GBR; Procedure: VST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mid facial recession
soft tissue stability measured in mm as difference In mid facial recession between pre operative and six months post operative
Measured: 6 months after final restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental Implant PlacementStudies of the same condition, open and under way.
- 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
- To address the labial plate of bone defect, a conventional mucoperiosteal flap will be utilized along with guided bone regeneration (GBR). GBR is a surgical technique that involves the use of bone grafts and barrier membranes to reconstruct buccal osseous defects around dental implants
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115758
- Sponsor's protocol ID
- 24-093
- Acronym
- VST
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: study data available upon resonable request due to privacy
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vestibular Versus Trapezoidal Flap Design on Immediate Implants : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07115758
- Acronym / sponsor ID
- VST / 24-093
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
The vestibular socket therapy was introduced by Elaskary et al that allowed immediate implant placement and total socket rehabilitation at the same time in class 2 compromised sockets , that showed supreme esthetic and functional predictability over 1,2,3 years of follow up, and showed minimal or no post restorative mid facial recession . The Vestibular socket therapy (VST) entails socket augmentation through a minimally invasive vestibular access incision to allow the delivery of the grafting components thus bypass the deleterious effect of the classic mucoperiosteal flap reflection as well as the deleterious effect of the delay approach, regardless of the degree of socket compromise [6-8].
Detailed description
The concept of promptly replacing teeth using dental implants was introduced many years ago as a way to reduce the time between tooth extraction and the completion of prosthetic restoration. However, immediate implant placement was not recommended by many authors such as Buser D, and Yong , due to the lack of buccal bone, presence of infection, and the continuing post extraction bone remodeling that occurs along both buccal and lingual plates walls of the socket.It has been proposed that the subsequent resorption of the socket walls after tooth extraction should be taken into account when developing any future treatment plan. Furthermore, the labial plate of bone is already compromised in type II extraction socket and is indicated for guided bone regeneration (GBR) such as early placement protocol, using the contour augmentation procedure. Many authors have conducted immediate implant placement using the conventional immediate implant placement via reflecting a mucoperiosteal flap that enabled the accurate socket debridement , total visibility of the socket environment and the ability to graft the buccal osseous defect.To address the labial plate of bone defect, a conventional mucoperiosteal flap will be utilized along with guided bone regeneration (GBR). GBR is a surgical technique that involves the use of bone grafts and barrier membranes to reconstruct buccal osseous defects around dental implants [10]. Typically, this procedure is performed on defects that are equal to or greater than 2 mm in size, such as dehiscence or fenestration defects. Tension-free primary closure will then achieved either on a cover screw or a healing abutment, several flap designs were proposed to minimize the deleterious effect of the classic approach such as papilla preservative incision and buccal esthetic flaps technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To address the labial plate of bone defect, a conventional mucoperiosteal flap will be utilized along with guided bone regeneration (GBR). GBR is a surgical technique that involves the use of bone grafts and barrier membranes to reconstruct buccal osseous defects around dental implants
| Arm | Type | Receives |
|---|---|---|
| VST | Experimental | Procedure: control GBR, Procedure: VSTElaskary Vestibular socket therapy instruments will be used for the intervention, A 1 cm long vestibular access incision at the allocated hopeless tooth will be made at the base of the hopeless tooth to the adjacent teeth. The vestibular pouch will then be dissected in an incisal direction exposing the total socket area and allowing direct access to the socket environment. An immediate implant will be installed using a surgical guide. A membrane shield 1 mm thick will be, trimmed, and tucked through the vestibular access incision starting at 1 mm beyond the socket orifice and reaching to the apical area of the socket. The gap and/ or the defect between the implant body and the shield will then be filled with the same grafting components so the control group. Finally, the vestibular incision will be secured with sutures. The socket will be sealed with a customized healing abutment. |
| GBR | Active comparator | Procedure: control GBR, Procedure: VSTwill have a full thickness papilla preservation FLAP, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having a hopeless maxillary tooth in the esthetic region missing coronal tooth structure, type II socket (deficient labial plate of bone and intact overlying soft tissues), adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.
Key exclusion criteria (1 listed)
- Smokers, pregnant women, patients with systemic diseases, and history of chemotherapy or radiotherapy within the past 2 years.
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 |
|---|---|---|
| control GBRwill have a full thickness papilla preservation FLAP, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position. | Procedure or surgery | GBR, VST |
| VSTPre extraction procedure: Prior to tooth extraction, cone beam computed tomography (CBCT) images will be taken to inspect the overall socket condition. All patients will be scanned pre-operatively using an intra-oral scanner (IOS). Extraction protocol: incisal extraction technique, where atraumatic tooth extraction to the hopeless tooth will be performed using periotomes followed by conventional forceps. | Procedure or surgery | GBR, VST |
Primary outcome
Changes in mid facial recession
Time frame: 6 months after final restoration
soft tissue stability measured in mm as difference In mid facial recession between pre operative and six months post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No. study data available upon resonable request due to privacy
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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.
Faculty of oral and dental medicine the british university in egypt elsherouk
Cairo, Egypt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VST in people with Immediate Dental Implant Placement and Defect in Alveolar Ridge, run by British University In Egypt at 3 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mid facial recession (time frame: 6 months after final restoration). 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 11 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.