Immediate Dental Implant in Type 2 Extraction SocketVSTNCT07526272
Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets
A study testing Immediate implant and VST using cortical lamina. and Immediate implant and VST using Magnesium membrane. in people with Immediate Dental Implant in Type 2 Extraction Socket and Vestibular Socket Therapy, run by Mohamed Adel Alfeky at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial evaluates the effectiveness of bioresorbable magnesium membranes compared to traditional cortical lamina in Vestibular Socket Therapy (VST) for immediate implant placement in Type II extraction sockets. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immediate Dental Implant in Type 2 Extraction Socket, Vestibular Socket Therapy
- What is being tested?
- Immediate implant and VST using cortical lamina. and Immediate implant and VST using Magnesium membrane.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2026to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single or multiple teeth with hopeless prognosis in maxillary anterior teeth with either type I or type II extraction sockets.
- Deficient labial bone plate in width (type I) and height (type II) sockets.
- Minimal of 3.0 mm basal bone present for immediate implant placement to achieve optimum primary stability.
Who cannot join
- Current smokers.
- Patients with debilitating systemic disease.
- Patients who have undergone any sort of radiotherapy and chemotherapy in past 2 years.
- Pregnant and Lactating females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Misr University for Science and Technology
Giza
Mohamed A Alfeky, +201060104208, mohamed.alfeky@must.edu.eg
About this study
Official title: Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluates the effectiveness of bioresorbable magnesium membranes compared to traditional cortical lamina in Vestibular Socket Therapy (VST) for immediate implant placement in Type II extraction sockets. The study utilizes Vestibular Socket Therapy (VST), a minimally invasive technique that involves a small incision and a subperiosteal tunnel to place a "bone shield" and graft without the need to raise a traditional flap.
The trial compares two distinct materials used as the regenerative barrier: the control group utilizes a cortical lamina, which is a rigid bone plate known for its stability and slow resorption rate. The experimental group receives a magnesium membrane, an emerging class of "bioresorbable metals" that provides mechanical stability similar to titanium while releasing ions that stimulate bone-building cells and promote blood vessel growth. The study involves 24 patients who are monitored from baseline to six months post-surgery.
The primary goal is to measure volumetric bone changes-specifically the thickness and height of the facial bone-using superimposed 3D scans (CBCT). Additionally, the protocol tracks secondary outcomes such as esthetic results via the Pink Esthetic Score, mucosal thickness, oral hygiene levels, patient-reported pain, and overall satisfaction with the restoration.
- Being tested
- Immediate implant and VST using cortical lamina., Immediate implant and VST using Magnesium membrane.
- Keywords
- VST, Vestibular Socket Therapy, Magnesium Membrane, Type 2 extraction socket, Mg Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant and VST using cortical lamina.Procedure or surgery
Following a minimally traumatic removal of the denoted tooth, placement of bone-level implants using a prefabricated surgical stent is done with the implant shoulder placed 3 to 4 mm apical to the labial gingival margin Cortical bone shield (Lamina Osteobiol, Technoss, USA) is hydrated, trimmed, and packed through the vestibular access incision until it extended 1 mm below the socket orifice. It is then stabilized to the apical bone and the peri-implant space was filled with particulate xenograft. The vestibular incision was secured and sutured using the 6/0 non-resorbable suture material. A prefabricated PMMA provisional restoration is used to seal the socket.
Immediate implant and VST using Magnesium membrane.Procedure or surgery
Following a minimally traumatic removal of the denoted tooth, placement of bone-level implants using a prefabricated surgical stent is done with the implant shoulder placed 3 to 4 mm apical to the labial gingival margin.
A sterile, resorbable magnesium membrane (NovaMag, Botiss, Germany) is trimmed to the shape of the defect, inserted through the vestibular incision and stabilized to the apical bone to cover the facial defect, acting as a "bone shield and the peri-implant space was filled with particulate xenograft.
The vestibular incision was secured and sutured using the 6/0 non-resorbable suture material. A prefabricated PMMA provisional restoration is used to seal the socket.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Immediate implant and VST using cortical lamina. Receives: Procedure: Immediate implant and VST using cortical lamina. |
| Test Group | Experimental | Immediate implant and VST using magnesium membrane. Receives: Procedure: Immediate implant and VST using Magnesium membrane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Volumetric changes
Volumetric changes of the facial bone will be assessed using high-resolution Cone Beam Computed Tomography (CBCT) scans.
Facial bone thickness will be measured as the horizontal distance in millimeters (mm) from the implant surface to the outer contour of the facial bone plate. Measurements will be recorded at three distinct vertical levels: at the crestal bone level, at half of the implant length and at the implant apex. Facial bone height will be measured as a line parallel to the implant long axis from the implant apex to the labial bone plate crest.
Measured: Baseline and 6-months post-operative.
Secondary outcomes (6)
Peri-implant soft tissue esthetic outcome
Peri-implant Soft Tissue Esthetic Outcomes will be evaluated at the T1 using the Pink Esthetic Score (PES). The seven variables of the PES (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color, and texture) will be scored from 0 (poor) to 2 (excellent), yielding a maximum score of 14.
Measured: 6-months post-operative.
Peri-implant mucosal thickness
Mucosal thickness will be measured on the mid-sagittal plane as the horizontal distance in millimeters (mm) from the outer surface of the facial bone (or implant surface if bone is absent) to the outer surface of the mucosa at a standardized point, 2mm apical to the free gingival margin.
Measured: Baseline and 6-months post-operative.
Plaque Index (PI)
Plaque accumulation will be assessed at four surfaces per site (mesio-buccal, mid-buccal, disto-buccal, and lingual) using Silness \& Löe plaque index (1964). Scores are assigned on a scale from 0 to 3, where 0 represents no plaque and 3 represents an abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate greater plaque accumulation.
Measured: Baseline, 1 month, 3 months and 6 months.
Gingival Index (GI)
Gingival inflammation will be assessed at four surfaces per site (mesio-buccal, mid-buccal, disto-buccal, and lingual) using the Löe \& Silness Gingival Index (1963). Scores are assigned on a scale from 0 to 3, where 0 represents normal gingiva and 3 represents severe inflammation (marked redness and edema, ulceration, tendency to spontaneous bleeding). Higher scores indicate more severe gingival inflammation.
Measured: Baseline, 1 month, 3 months, and 6 months.
Post-surgical Pain
Using a 100-mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable"(Huskisson, 1974).
Measured: At 6, 12, and 24 hours post-operatively, then daily for 7 days.
Patient Satisfaction
using a specifically designed questionnaire evaluating the level of general satisfaction with the outcome of their implant-supported restorations, comfort, speech, esthetics, function, and cleanability.15 Responses were recorded using five-point agreement Likert scale with the five answers options of strongly agree (5), agree (4), I do not know (3), disagree (2), and strongly disagree (1) (Alssum et al., 2025).
Measured: 6-months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start12 Mar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 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 in Type 2 Extraction SocketStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Adel Alfeky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Adel Alfeky, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526272
- Sponsor's protocol ID
- 001
- Acronym
- VST
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07526272
- Acronym / sponsor ID
- VST / 001
- Keywords
- VST, Vestibular Socket Therapy, Magnesium Membrane, Type 2 extraction socket, Mg Membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mohamed Adel AlfekyUniversity, hospital or other
- Study start
- 12 Mar 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Apr 2026 (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.
This randomized controlled clinical trial evaluates the effectiveness of bioresorbable magnesium membranes compared to traditional cortical lamina in Vestibular Socket Therapy (VST) for immediate implant placement in Type II extraction sockets. The study utilizes Vestibular Socket Therapy (VST), a minimally invasive technique that involves a small incision and a subperiosteal tunnel to place a "bone shield" and graft without the need to raise a traditional flap.
The trial compares two distinct materials used as the regenerative barrier: the control group utilizes a cortical lamina, which is a rigid bone plate known for its stability and slow resorption rate. The experimental group receives a magnesium membrane, an emerging class of "bioresorbable metals" that provides mechanical stability similar to titanium while releasing ions that stimulate bone-building cells and promote blood vessel growth. The study involves 24 patients who are monitored from baseline to six months post-surgery.
The primary goal is to measure volumetric bone changes-specifically the thickness and height of the facial bone-using superimposed 3D scans (CBCT). Additionally, the protocol tracks secondary outcomes such as esthetic results via the Pink Esthetic Score, mucosal thickness, oral hygiene levels, patient-reported pain, and overall satisfaction with the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Immediate implant and VST using cortical lamina.Immediate implant and VST using cortical lamina. |
| Test Group | Experimental | Procedure: Immediate implant and VST using Magnesium membrane.Immediate implant and VST using magnesium membrane. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Single or multiple teeth with hopeless prognosis in maxillary anterior teeth with either type I or type II extraction sockets.
- Deficient labial bone plate in width (type I) and height (type II) sockets.
- Minimal of 3.0 mm basal bone present for immediate implant placement to achieve optimum primary stability.
Key exclusion criteria (4 listed)
- Current smokers.
- Patients with debilitating systemic disease.
- Patients who have undergone any sort of radiotherapy and chemotherapy in past 2 years.
- Pregnant and Lactating females.
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 and VST using cortical lamina.Following a minimally traumatic removal of the denoted tooth, placement of bone-level implants using a prefabricated surgical stent is done with the implant shoulder placed 3 to 4 mm apical to the labial gingival margin Cortical bone shield (Lamina Osteobiol, Technoss, USA) is hydrated, trimmed, and packed through the vestibular access incision until it extended 1 mm below the socket orifice. It is then stabilized to the apical bone and the peri-implant space was filled with particulate xenograft. The vestibular incision was secured and sutured using the 6/0 non-resorbable suture material. A prefabricated PMMA provisional restoration is used to seal the socket. | Procedure or surgery | Control Group |
| Immediate implant and VST using Magnesium membrane.Following a minimally traumatic removal of the denoted tooth, placement of bone-level implants using a prefabricated surgical stent is done with the implant shoulder placed 3 to 4 mm apical to the labial gingival margin. A sterile, resorbable magnesium membrane (NovaMag, Botiss, Germany) is trimmed to the shape of the defect, inserted through the vestibular incision and stabilized to the apical bone to cover the facial defect, acting as a "bone shield and the peri-implant space was filled with particulate xenograft. The vestibular incision was secured and sutured using the 6/0 non-resorbable suture material. A prefabricated PMMA provisional restoration is used to seal the socket. | Procedure or surgery | Test Group |
Primary outcome
Bone Volumetric changes
Time frame: Baseline and 6-months post-operative.
Volumetric changes of the facial bone will be assessed using high-resolution Cone Beam Computed Tomography (CBCT) scans. Facial bone thickness will be measured as the horizontal distance in millimeters (mm) from the implant surface to the outer contour of the facial bone plate. Measurements will be recorded at three distinct vertical levels: at the crestal bone level, at half of the implant length and at the implant apex. Facial bone height will be measured as a line parallel to the implant long axis from the implant apex to the labial bone plate crest.
6 secondary outcomes
Peri-implant soft tissue esthetic outcome
Time frame: 6-months post-operative.
Peri-implant mucosal thickness
Time frame: Baseline and 6-months post-operative.
Plaque Index (PI)
Time frame: Baseline, 1 month, 3 months and 6 months.
Gingival Index (GI)
Time frame: Baseline, 1 month, 3 months, and 6 months.
Post-surgical Pain
Time frame: At 6, 12, and 24 hours post-operatively, then daily for 7 days.
Patient Satisfaction
Time frame: 6-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 13 Apr 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant and VST using cortical lamina. and Immediate implant and VST using Magnesium membrane. in people with Immediate Dental Implant in Type 2 Extraction Socket and Vestibular Socket Therapy, run by Mohamed Adel Alfeky 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 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
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?
Contact Mohamed A Alfeky (+201060104208, mohamed.alfeky@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Volumetric changes (time frame: Baseline and 6-months post-operative.). 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 13 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.