Alveolar Bone LossVSTNCT07784764
VST vs Modified Periosteal Inhibition Technique
A study testing VST and Mucoperiosteal inhibition in people with Alveolar Bone Loss, run by Tanta University.
Trial summary
Losing a tooth in the upper front of the mouth is common, and many people choose a dental implant to replace it. When a tooth is removed, the thin layer of bone in front of the socket - the buccal, or front, bone - often shrinks as the area heals. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- VST and Mucoperiosteal inhibition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 10 Apr 2027
- 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
- Adults aged 20 to 50 years Non-restorable tooth in the maxillary anterior region (canine to canine) Elian Class II extraction socket (facial soft tissue present, buccal plate partially missing) confirmed on cone-beam computed tomography (CBCT) Bone quality D2 to D3 on preoperative CBCT At least 3 mm of keratinized gingiva at the site Good compliance, evidenced by no missed appointments and a positive attitude toward oral hygiene
Who cannot join
- Medically compromised patients or systemic conditions precluding implant or periodontal surgery Smokers Pregnant or lactating women History of chemotherapy or head and/or neck radiotherapy Bisphosphonate therapy Uncontrolled diabetes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vestibular Socket Therapy Versus Modified Periosteal Inhibition Technique With Immediate Implant Placement in Compromised Extraction Sockets in the Esthetic Zone: A Randomized Controlled Clinical Trial
Losing a tooth in the upper front of the mouth is common, and many people choose a dental implant to replace it. When a tooth is removed, the thin layer of bone in front of the socket - the buccal, or front, bone - often shrinks as the area heals. If this bone shrinks, the final implant can look less natural and the gum can recede. The problem is greater when part of the front bone is already missing at the time the tooth is taken out; this type of socket is harder to treat.
This study compares two surgical techniques that aim to protect the front bone and gum while a dental implant is placed on the same day the tooth is removed. In Vestibular Socket Therapy (VST), a thin bone membrane is inserted through a small incision high in the gum fold to cover the front bone, and bone graft material is packed into the socket. In Modified Periosteal Inhibition (MPI), a thin bone membrane is placed against the outside of the front bone and held in place with a tissue glue, and the socket is filled with a collagen sponge.
Read more
Adults aged 20 to 50 with a non-restorable upper front tooth (canine to canine) and partial loss of the front bone can take part. Participants are randomly assigned to one of the two techniques and receive an implant immediately after the tooth is removed, then are followed for 12 months. Using cone-beam CT scans, intraoral scans, and an esthetic (appearance) score taken at the start and at 6 and 12 months, the investigators measure the thickness of the front bone, the level and thickness of the gum around the implant, and the overall appearance.
The study tests whether one technique preserves or increases the thickness of the front bone and produces better gum and esthetic results than the other.
Read the detailed description
Background: Tooth extraction produces dimensional changes of the alveolar ridge that are most pronounced in the anterior maxilla. Extraction sockets with a partially missing buccal plate but intact facial soft tissue (Elian Class II) are particularly difficult to manage, because loss of the facial bone after immediate implant placement can lead to soft-tissue recession and a compromised esthetic result. Several approaches have been proposed to protect or reinforce the facial bone at the time of immediate placement. Vestibular Socket Therapy (VST) uses a cortical bone membrane delivered through a vestibular access incision to cover the facial socket wall, together with particulate bone graft and a customized healing abutment that seals the socket. Modified Periosteal Inhibition (MPI) places a resorbable xenogenic cortical bone lamina between the labial periosteum and the labial bone plate, fixed with a cyanoacrylate tissue adhesive, with the socket filled by a collagen sponge. Both techniques are used with immediate implant placement, but they have not been directly compared.
Objective: To evaluate and compare VST versus MPI, each combined with immediate implant placement, for the management of compromised (Elian Class II) extraction sockets in the maxillary esthetic zone, with respect to facial bone thickness, peri-implant soft-tissue level and thickness, and esthetic outcomes.
Design: This is a single-center, parallel-group, two-arm randomized controlled clinical trial with 1:1 allocation, conducted at the Faculty of Dentistry, Tanta University. Forty-two eligible participants with a non-restorable maxillary anterior tooth and an Elian Class II socket confirmed on cone-beam computed tomography (CBCT) are allocated to one of two groups (21 sites each) using sequentially numbered, opaque, sealed envelopes (SNOSE). Outcome assessment and statistical analysis are performed blinded to group allocation.
Sample size: The target of 42 participants (21 per group) provides 80% power at a 5% significance level to detect the difference in buccal bone gain reported for the two techniques in prior studies, using the larger standard deviation to yield an effect size of approximately 0.925 (G*Power 3.1.9.7); the figure includes an allowance for dropout.
Interventions: All participants first receive phase I periodontal therapy (scaling and root planing, oral-hygiene instruction). The non-restorable tooth is extracted atraumatically and the socket is debrided and confirmed as Elian Class II with adequate interproximal bone. In both groups the implant is placed using a computer-guided surgical template, with the implant shoulder positioned 3 to 4 mm apical to the labial gingival margin. In the VST group, a xenogenic cortical bone membrane trimmed to the facial socket wall is inserted through a vestibular access incision and stabilized with bone tacks, and particulate xenograft is placed in the socket. In the MPI group, a conservative full-thickness flap is raised, and a resorbable xenogenic bone membrane is placed between the labial periosteum and the labial bone plate, fixed with cyanoacrylate adhesive, with a collagen sponge placed in the socket. In both groups the socket is sealed with a customized healing abutment and closed with non-resorbable sutures. Postoperative care includes a chlorhexidine 0.1% rinse, an amoxicillin-clavulanate and metronidazole antibiotic regimen, and ibuprofen.
Assessment: Participants are evaluated at baseline, 6 months, and 12 months. Facial bone thickness and peri-implant bone levels from crest to apex are measured on CBCT. Peri-implant mucosal level and mucosal thickness are assessed by superimposing intraoral scan (STL) files on CBCT-derived data, and esthetics are scored using the simplified pink esthetic score. Data are summarized as means and standard deviations, with within-group and between-group comparisons at a significance level of p < 0.05; analysis is carried out blinded to group.
- Conditions
- Alveolar Bone Loss
- Being tested
- VST, Mucoperiosteal inhibition
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSTProcedure or surgery
Immediate implant placement with Vestibular Socket Therapy. Following atraumatic extraction and socket debridement, a submucoperiosteal tunnel is prepared from the facial socket orifice to a vestibular access incision made 3-4 mm apical to the mucogingival junction. The implant is placed via a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A xenogenic cortical bone membrane is trimmed to the facial socket wall, inserted through the vestibular incision, and fixed with bone tacks; particulate xenograft is placed in the socket. The socket is sealed with a customized healing abutment and the vestibular incision closed with non-resorbable sutures.
Mucoperiosteal inhibitionProcedure or surgery
Immediate implant placement with the Modified Periosteal Inhibition technique. Following atraumatic extraction and socket debridement, a conservative full-thickness flap is raised (extending one tooth mesial and distal), and the labial periosteum is detached from the labial bone plate. The implant is placed via a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A resorbable xenogenic bone membrane is inserted between the labial periosteum and the labial bone plate and fixed with cyanoacrylate tissue adhesive; a collagen sponge is placed in the socket. The socket is sealed with a customized healing abutment and the flap closed with non-resorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| VST | Experimental | Immediate implant placement combined with Vestibular Socket Therapy (VST). After atraumatic extraction of the non-restorable maxillary anterior tooth, the implant is placed with a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A xenogenic cortical bone membrane is inserted through a vestibular access incision to cover the facial bone plate and stabilized with bone tacks, particulate xenograft is placed in the socket, and the socket is sealed with a customized healing abutment. Receives: Procedure: VST |
| Modified Periosteal inhibition | Active comparator | Immediate implant placement combined with the Modified Periosteal Inhibition (MPI) technique. After atraumatic extraction of the non-restorable maxillary anterior tooth, the implant is placed using a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A conservative full-thickness flap is raised, and a resorbable xenogenic bone membrane is placed between the labial periosteum and the labial bone plate, fixed with cyanoacrylate tissue adhesive; a collagen sponge is placed in the socket, and the socket is sealed with a customized healing abutment. Receives: Procedure: Mucoperiosteal inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in facial (buccal) bone thickness
Facial bone thickness on the buccal aspect of the implant, measured in millimeters on cone-beam computed tomography (CBCT). Thickness is measured at standardized reference levels from the implant platform apically, and the change from baseline is calculated. A greater increase (or smaller reduction) indicates better preservation of the facial bone.
Measured: 6 months
Secondary outcomes (2)
Change in peri-implant bone level (crest to apex)
Vertical peri-implant bone level measured in millimeters on CBCT from the implant platform to the first bone-to-implant contact, assessed from the crest apically; change from baseline is calculated. Less reduction indicates better crestal bone maintenance.
Measured: 6 months
Change in peri-implant mucosal level
Peri-implant mid-facial mucosal (soft-tissue) level measured in millimeters by superimposing intraoral scan (STL) files on the reference dataset; change from baseline is calculated. A more coronal position (less recession) indicates a more favorable soft-tissue outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Talaat Zeyada, Tanta University
- Investigators
- Sahar Ghoraba, PhD, Study director, Professor of Oral Medicine and Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784764
- Sponsor's protocol ID
- OMPDR3-253345
- Acronym
- VST
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Socket Therapy Versus Modified Periosteal Inhibition Technique With Immediate Implant Placement in Compromised Extraction Sockets in the Esthetic Zone: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07784764
- Acronym / sponsor ID
- VST / OMPDR3-253345
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 25 Aug 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.
Losing a tooth in the upper front of the mouth is common, and many people choose a dental implant to replace it. When a tooth is removed, the thin layer of bone in front of the socket - the buccal, or front, bone - often shrinks as the area heals. If this bone shrinks, the final implant can look less natural and the gum can recede. The problem is greater when part of the front bone is already missing at the time the tooth is taken out; this type of socket is harder to treat.
This study compares two surgical techniques that aim to protect the front bone and gum while a dental implant is placed on the same day the tooth is removed. In Vestibular Socket Therapy (VST), a thin bone membrane is inserted through a small incision high in the gum fold to cover the front bone, and bone graft material is packed into the socket. In Modified Periosteal Inhibition (MPI), a thin bone membrane is placed against the outside of the front bone and held in place with a tissue glue, and the socket is filled with a collagen sponge.
Adults aged 20 to 50 with a non-restorable upper front tooth (canine to canine) and partial loss of the front bone can take part. Participants are randomly assigned to one of the two techniques and receive an implant immediately after the tooth is removed, then are followed for 12 months. Using cone-beam CT scans, intraoral scans, and an esthetic (appearance) score taken at the start and at 6 and 12 months, the investigators measure the thickness of the front bone, the level and thickness of the gum around the implant, and the overall appearance.
The study tests whether one technique preserves or increases the thickness of the front bone and produces better gum and esthetic results than the other.
Detailed description
Background: Tooth extraction produces dimensional changes of the alveolar ridge that are most pronounced in the anterior maxilla. Extraction sockets with a partially missing buccal plate but intact facial soft tissue (Elian Class II) are particularly difficult to manage, because loss of the facial bone after immediate implant placement can lead to soft-tissue recession and a compromised esthetic result. Several approaches have been proposed to protect or reinforce the facial bone at the time of immediate placement. Vestibular Socket Therapy (VST) uses a cortical bone membrane delivered through a vestibular access incision to cover the facial socket wall, together with particulate bone graft and a customized healing abutment that seals the socket. Modified Periosteal Inhibition (MPI) places a resorbable xenogenic cortical bone lamina between the labial periosteum and the labial bone plate, fixed with a cyanoacrylate tissue adhesive, with the socket filled by a collagen sponge. Both techniques are used with immediate implant placement, but they have not been directly compared.
Objective: To evaluate and compare VST versus MPI, each combined with immediate implant placement, for the management of compromised (Elian Class II) extraction sockets in the maxillary esthetic zone, with respect to facial bone thickness, peri-implant soft-tissue level and thickness, and esthetic outcomes.
Design: This is a single-center, parallel-group, two-arm randomized controlled clinical trial with 1:1 allocation, conducted at the Faculty of Dentistry, Tanta University. Forty-two eligible participants with a non-restorable maxillary anterior tooth and an Elian Class II socket confirmed on cone-beam computed tomography (CBCT) are allocated to one of two groups (21 sites each) using sequentially numbered, opaque, sealed envelopes (SNOSE). Outcome assessment and statistical analysis are performed blinded to group allocation.
Sample size: The target of 42 participants (21 per group) provides 80% power at a 5% significance level to detect the difference in buccal bone gain reported for the two techniques in prior studies, using the larger standard deviation to yield an effect size of approximately 0.925 (G*Power 3.1.9.7); the figure includes an allowance for dropout.
Interventions: All participants first receive phase I periodontal therapy (scaling and root planing, oral-hygiene instruction). The non-restorable tooth is extracted atraumatically and the socket is debrided and confirmed as Elian Class II with adequate interproximal bone. In both groups the implant is placed using a computer-guided surgical template, with the implant shoulder positioned 3 to 4 mm apical to the labial gingival margin. In the VST group, a xenogenic cortical bone membrane trimmed to the facial socket wall is inserted through a vestibular access incision and stabilized with bone tacks, and particulate xenograft is placed in the socket. In the MPI group, a conservative full-thickness flap is raised, and a resorbable xenogenic bone membrane is placed between the labial periosteum and the labial bone plate, fixed with cyanoacrylate adhesive, with a collagen sponge placed in the socket. In both groups the socket is sealed with a customized healing abutment and closed with non-resorbable sutures. Postoperative care includes a chlorhexidine 0.1% rinse, an amoxicillin-clavulanate and metronidazole antibiotic regimen, and ibuprofen.
Assessment: Participants are evaluated at baseline, 6 months, and 12 months. Facial bone thickness and peri-implant bone levels from crest to apex are measured on CBCT. Peri-implant mucosal level and mucosal thickness are assessed by superimposing intraoral scan (STL) files on CBCT-derived data, and esthetics are scored using the simplified pink esthetic score. Data are summarized as means and standard deviations, with within-group and between-group comparisons at a significance level of p < 0.05; analysis is carried out blinded to group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VST | Experimental | Procedure: VSTImmediate implant placement combined with Vestibular Socket Therapy (VST). After atraumatic extraction of the non-restorable maxillary anterior tooth, the implant is placed with a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A xenogenic cortical bone membrane is inserted through a vestibular access incision to cover the facial bone plate and stabilized with bone tacks, particulate xenograft is placed in the socket, and the socket is sealed with a customized healing abutment. |
| Modified Periosteal inhibition | Active comparator | Procedure: Mucoperiosteal inhibitionImmediate implant placement combined with the Modified Periosteal Inhibition (MPI) technique. After atraumatic extraction of the non-restorable maxillary anterior tooth, the implant is placed using a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A conservative full-thickness flap is raised, and a resorbable xenogenic bone membrane is placed between the labial periosteum and the labial bone plate, fixed with cyanoacrylate tissue adhesive; a collagen sponge is placed in the socket, and the socket is sealed with a customized healing abutment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 20 to 50 years Non-restorable tooth in the maxillary anterior region (canine to canine) Elian Class II extraction socket (facial soft tissue present, buccal plate partially missing) confirmed on cone-beam computed tomography (CBCT) Bone quality D2 to D3 on preoperative CBCT At least 3 mm of keratinized gingiva at the site Good compliance, evidenced by no missed appointments and a positive attitude toward oral hygiene
Key exclusion criteria (1 listed)
- Medically compromised patients or systemic conditions precluding implant or periodontal surgery Smokers Pregnant or lactating women History of chemotherapy or head and/or neck radiotherapy Bisphosphonate therapy Uncontrolled diabetes
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 |
|---|---|---|
| VSTImmediate implant placement with Vestibular Socket Therapy. Following atraumatic extraction and socket debridement, a submucoperiosteal tunnel is prepared from the facial socket orifice to a vestibular access incision made 3-4 mm apical to the mucogingival junction. The implant is placed via a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A xenogenic cortical bone membrane is trimmed to the facial socket wall, inserted through the vestibular incision, and fixed with bone tacks; particulate xenograft is placed in the socket. The socket is sealed with a customized healing abutment and the vestibular incision closed with non-resorbable sutures. | Procedure or surgery | VST |
| Mucoperiosteal inhibitionImmediate implant placement with the Modified Periosteal Inhibition technique. Following atraumatic extraction and socket debridement, a conservative full-thickness flap is raised (extending one tooth mesial and distal), and the labial periosteum is detached from the labial bone plate. The implant is placed via a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A resorbable xenogenic bone membrane is inserted between the labial periosteum and the labial bone plate and fixed with cyanoacrylate tissue adhesive; a collagen sponge is placed in the socket. The socket is sealed with a customized healing abutment and the flap closed with non-resorbable sutures. | Procedure or surgery | Modified Periosteal inhibition |
Primary outcome
Change in facial (buccal) bone thickness
Time frame: 6 months
Facial bone thickness on the buccal aspect of the implant, measured in millimeters on cone-beam computed tomography (CBCT). Thickness is measured at standardized reference levels from the implant platform apically, and the change from baseline is calculated. A greater increase (or smaller reduction) indicates better preservation of the facial bone.
2 secondary outcomes
Change in peri-implant bone level (crest to apex)
Time frame: 6 months
Change in peri-implant mucosal level
Time frame: 6 months
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sahar Ghoraba, PhD study director
Professor of Oral Medicine and Periodontology
Questions about this trial
What is this clinical trial studying?
A study testing VST and Mucoperiosteal inhibition in people with Alveolar Bone Loss, run by Tanta University.
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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shady Talaat Zeyada, BDS (+201007302754, dr.shady96.st@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial (buccal) bone thickness (time frame: 6 months). 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 25 Aug 2026.