Type II Extraction Sockets in the Esthetic ZoneNCT07800377
Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina in the Esthetic Zone.
A study testing Vestibular Socket Therapy Using Magnesium Membrane and Vestibular Socket Therapy Using Cortical Lamina in people with Type II Extraction Sockets in the Esthetic Zone, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type II Extraction Sockets in the Esthetic Zone
- What is being tested?
- Vestibular Socket Therapy Using Magnesium Membrane and Vestibular Socket Therapy Using Cortical Lamina
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Jun 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years.
- Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets.
- Presence of adequate palatal and apical bone to achieve primary implant stability.
- Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation.
- Good oral hygiene and satisfactory plaque control
Who cannot join
- Acute infection at the intended implant site (e.g., acute abscess or cellulitis).
- Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration.
- History of irradiation to the head and neck region within one year before implant placement.
- Alcohol or drug abuse.
- Pregnancy or lactation.
- Parafunctional habits such as bruxism or clenching.
- Current smoking or tobacco using.
- Poor oral hygiene or inability to maintain adequate plaque control.
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
Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery, +201000985501, dinahosam90@gmail.com
Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery
About this study
Official title: Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
This randomized clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone.
A total of 30 patients will be randomly allocated to receive VST using either a biodegradable magnesium membrane or a cortical lamina membrane. Both groups will receive immediate implant placement and xenogeneic bone graft.
The study will compare changes in facial bone dimensions, soft tissue volume, implant stability, pink esthetic score, patient satisfaction, surgical time, and postoperative complications over a 6-month follow-up period.
- Being tested
- Vestibular Socket Therapy Using Magnesium Membrane, Vestibular Socket Therapy Using Cortical Lamina
- Keywords
- Vestibular Socket Therapy, VST, Type II Extraction Sockets, Immediate Implant Placement, Magnesium Membrane, Cortical Lamina, Esthetic Zone, Facial Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Socket Therapy Using Magnesium MembraneProcedure or surgery
Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
Vestibular Socket Therapy Using Cortical LaminaProcedure or surgery
Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Socket Therapy Using Magnesium Membrane | Experimental | Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone. Receives: Procedure: Vestibular Socket Therapy Using Magnesium Membrane |
| Vestibular Socket Therapy Using Cortical Lamina | Active comparator | Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone. Receives: Procedure: Vestibular Socket Therapy Using Cortical Lamina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Bone Dimensional Changes
CBCT scans obtained immediately after surgery (T0) and at six months (T6) will be superimposed using OnDemand3D software. The following parameters will be assessed: facial bone thickness at the crestal level, facial bone thickness at the middle level, facial bone thickness at the apical level, and facial bone height.
Measured: Immediately after surgery (T0) and 6 months (T6)
Secondary outcomes (6)
Soft Tissue Volumetric Changes
Assessed by superimposition of intraoral scan STL files obtained at baseline and 6 months postoperatively.
Measured: Baseline and 6 months postoperatively
Implant Stability
Assessed using radiofrequency analysis (RFA) using an Osstell Mentor Device. A SmartPeg will be attached to each implant, and resonance frequency measurements will be recorded in four directions (every 90°). The obtained values will be expressed as Implant Stability Quotient (ISQ) scores, and the mean ISQ value for each implant will be used for statistical analysis. The Implant Stability Quotient (ISQ) ranges from 1 to 100, with higher scores indicating greater implant stability.
Measured: Immediately postoperatively, 3, and 6 months postoperatively.
Pink Esthetic Score (PES)
The Pink Esthetic Score (PES) assesses peri-implant soft tissue esthetics using seven parameters, each scored from 0 to 2, for a total score of 0-14. Higher scores indicate better esthetic outcomes. Assessed using standardized clinical photographs.
Measured: 6 months postoperatively.
Patient-reported Esthetic Satisfaction
Assessed at 6 months using a 100-mm Visual Analog Scale (VAS), where 0 indicates complete dissatisfaction and 100 indicates complete satisfaction with the esthetic result.
Measured: 6 months postoperatively
Surgical Time
Recorded in minutes from the start of the surgical procedure until completion.
Measured: During the surgical procedure
Postoperative Complications
Recorded throughout the follow-up period and evaluated at 1 week, 1 month, 3 months, and 6 months postoperatively for the occurrence of membrane exposure, wound dehiscence, infection, graft loss, and implant failure.
Measured: 1 week, 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type II Extraction Sockets in the Esthetic ZoneStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified according to extraction socket subtype and randomly assigned in a 1:1 ratio to receive Vestibular Socket Therapy using either a biodegradable magnesium membrane or a cortical lamina membrane.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Hosam Eldin Zaghloul, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800377
- Sponsor's protocol ID
- MS.26.08.271
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pinto A, Mazzetti V, Carosi P, Lorenzi C. Cortical Laminar Bone Membrane in Implant Dentistry: Biological Basis, Clinical Protocols, and Outcomes. Appl Sci. 2025;15(22):12243.
Elad A, Rider P, Rogge S, Witte F, Tadic D, Kacarevic ZP, Steigmann L. Application of Biodegradable Magnesium Membrane Shield Technique for Immediate Dentoalveolar Bone Regeneration. Biomedicines. 2023 Mar 1;11(3):744. doi: 10.3390/biomedicines11030744.
PubMed 36979728Elaskary 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 39375634ElAskary A, Elfana A, Meabed M, Abd-ElWahab Radi I, Akram M, Fawzy El-Sayed K. Immediate implant placement utilizing vestibular socket therapy versus early implant placement with contour augmentation for rehabilitation of compromised extraction sockets in the esthetic zone: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Oct;24(5):559-568. doi: 10.1111/cid.13120. Epub 2022 Jul 10.
PubMed 35811090Th Elaskary A, Y Gaweesh Y, Maebed MA, Cho SC, El Tantawi M. A Novel Method for Immediate Implant Placement in Defective Fresh Extraction Sites. Int J Oral Maxillofac Implants. 2020 Jul/Aug;35(4):799-807. doi: 10.11607/jomi.8052.
PubMed 32724934
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07800377
- Acronym / sponsor ID
- MS.26.08.271
- Keywords
- Vestibular Socket Therapy, VST, Type II Extraction Sockets, Immediate Implant Placement, Magnesium Membrane, Cortical Lamina, Esthetic Zone, Facial Bone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Sep 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 clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone.
A total of 30 patients will be randomly allocated to receive VST using either a biodegradable magnesium membrane or a cortical lamina membrane. Both groups will receive immediate implant placement and xenogeneic bone graft.
The study will compare changes in facial bone dimensions, soft tissue volume, implant stability, pink esthetic score, patient satisfaction, surgical time, and postoperative complications over a 6-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be stratified according to extraction socket subtype and randomly assigned in a 1:1 ratio to receive Vestibular Socket Therapy using either a biodegradable magnesium membrane or a cortical lamina membrane.
| Arm | Type | Receives |
|---|---|---|
| Vestibular Socket Therapy Using Magnesium Membrane | Experimental | Procedure: Vestibular Socket Therapy Using Magnesium MembraneVestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone. |
| Vestibular Socket Therapy Using Cortical Lamina | Active comparator | Procedure: Vestibular Socket Therapy Using Cortical LaminaVestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 45 years.
- Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets.
- Presence of adequate palatal and apical bone to achieve primary implant stability.
- Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation.
- Good oral hygiene and satisfactory plaque control
Key exclusion criteria (8 listed)
- Acute infection at the intended implant site (e.g., acute abscess or cellulitis).
- Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration.
- History of irradiation to the head and neck region within one year before implant placement.
- Alcohol or drug abuse.
- Pregnancy or lactation.
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 Using Magnesium MembraneVestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone. | Procedure or surgery | Vestibular Socket Therapy Using Magnesium Membrane |
| Vestibular Socket Therapy Using Cortical LaminaVestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone. | Procedure or surgery | Vestibular Socket Therapy Using Cortical Lamina |
Primary outcome
Facial Bone Dimensional Changes
Time frame: Immediately after surgery (T0) and 6 months (T6)
CBCT scans obtained immediately after surgery (T0) and at six months (T6) will be superimposed using OnDemand3D software. The following parameters will be assessed: facial bone thickness at the crestal level, facial bone thickness at the middle level, facial bone thickness at the apical level, and facial bone height.
6 secondary outcomes
Soft Tissue Volumetric Changes
Time frame: Baseline and 6 months postoperatively
Implant Stability
Time frame: Immediately postoperatively, 3, and 6 months postoperatively.
Pink Esthetic Score (PES)
Time frame: 6 months postoperatively.
Patient-reported Esthetic Satisfaction
Time frame: 6 months postoperatively
Surgical Time
Time frame: During the surgical procedure
Postoperative Complications
Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively
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 8 Sep 2026.
- Results publicationPinto A, Mazzetti V, Carosi P, Lorenzi C. Cortical Laminar Bone Membrane in Implant Dentistry: Biological Basis, Clinical Protocols, and Outcomes. Appl Sci. 2025;15(22):12243.
- Results publication: PubMed 36979728Elad A, Rider P, Rogge S, Witte F, Tadic D, Kacarevic ZP, Steigmann L. Application of Biodegradable Magnesium Membrane Shield Technique for Immediate Dentoalveolar Bone Regeneration. Biomedicines. 2023 Mar 1;11(3):744. doi: 10.3390/biomedicines11030744.
- Results publication: 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.
- Results publication: PubMed 35811090ElAskary A, Elfana A, Meabed M, Abd-ElWahab Radi I, Akram M, Fawzy El-Sayed K. Immediate implant placement utilizing vestibular socket therapy versus early implant placement with contour augmentation for rehabilitation of compromised extraction sockets in the esthetic zone: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Oct;24(5):559-568. doi: 10.1111/cid.13120. Epub 2022 Jul 10.
- Results publication: PubMed 32724934Th Elaskary A, Y Gaweesh Y, Maebed MA, Cho SC, El Tantawi M. A Novel Method for Immediate Implant Placement in Defective Fresh Extraction Sites. Int J Oral Maxillofac Implants. 2020 Jul/Aug;35(4):799-807. doi: 10.11607/jomi.8052.
- Individual participant dataSharing planned: Undecided
Related trials for Type II Extraction Sockets in the Esthetic Zone
Recruiting
Assessment of Labial Plate Thickness After Immediate Implant Placement Using Two Different Xenografts in the Esthetic Zone
Alveolar Bone Loss, Tooth Extraction Status Nos
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.
Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
Al Mansurah, Egypt
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 Using Magnesium Membrane and Vestibular Socket Therapy Using Cortical Lamina in people with Type II Extraction Sockets in the Esthetic Zone, run by Mansoura 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 5 inclusion and 8 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 8 Sep 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?
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?
Facial Bone Dimensional Changes (time frame: Immediately after surgery (T0) and 6 months (T6)). 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 NCT07800377, which also lists 5 linked publications.
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 8 Sep 2026.