CClinicalTrials.gg
Sign In
Not yet recruitingNCT07800377Updated Sep 8, 2026

Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina in the Esthetic Zone.

An interventional study of Vestibular Socket Therapy Using Magnesium Membrane and Vestibular Socket Therapy Using Cortical Lamina in Type II Extraction Sockets in the Esthetic Zone, sponsored by Mansoura University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Type II Extraction Sockets in the Esthetic Zone

Keywords

  • Vestibular Socket Therapy
  • VST
  • Type II Extraction Sockets
  • Immediate Implant Placement
  • Magnesium Membrane
  • Cortical Lamina
  • Esthetic Zone
  • Facial Bone
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18 and 45 years.
  2. Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets.
  3. Presence of adequate palatal and apical bone to achieve primary implant stability.
  4. Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation.
  5. Good oral hygiene and satisfactory plaque control

Exclusion criteria

Exclusion Criteria:

  1. Acute infection at the intended implant site (e.g., acute abscess or cellulitis).
  2. Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration.
  3. History of irradiation to the head and neck region within one year before implant placement.
  4. Alcohol or drug abuse.
  5. Pregnancy or lactation.
  6. Parafunctional habits such as bruxism or clenching.
  7. Current smoking or tobacco using.
  8. Poor oral hygiene or inability to maintain adequate plaque control.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Vestibular Socket Therapy Using Magnesium Membrane

    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.

    Procedure: Vestibular Socket Therapy Using Magnesium Membrane

  • Active comparator
    Vestibular Socket Therapy Using Cortical Lamina

    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.

    Procedure: Vestibular Socket Therapy Using Cortical Lamina

Interventions

  • ProcedureVestibular Socket Therapy Using Magnesium Membrane

    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.

  • ProcedureVestibular Socket Therapy Using Cortical Lamina

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after surgery (T0) and 6 months (T6)

Secondary outcomes

  1. Soft Tissue Volumetric Changes

    Assessed by superimposition of intraoral scan STL files obtained at baseline and 6 months postoperatively.

    Time frame: Baseline and 6 months postoperatively

  2. 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.

    Time frame: Immediately postoperatively, 3, and 6 months postoperatively.

  3. 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.

    Time frame: 6 months postoperatively.

  4. 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.

    Time frame: 6 months postoperatively

  5. Surgical Time

    Recorded in minutes from the start of the surgical procedure until completion.

    Time frame: During the surgical procedure

  6. 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.

    Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively

06

Study locations

1 site
  • Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
    Al Mansurah, Dakahlia Governorate 35511, Egypt
    • Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery · Contact · dinahosam90@gmail.com · +201000985501
    • Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery · Principal investigator
    • Nahed Ibrahim Ghoneim, PhD in Oral Surgery · Sub investigator
    • Ayman Moustafa Yaseen, PhD in Oral Surgery · Sub investigator
    • Ammar Taha Kassem, PhD in Prosthodontics · Sub investigator
07

References and documents

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 36979728 ↗
  • Elaskary 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 39375634 ↗
  • ElAskary 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 35811090 ↗
  • Th 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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07800377
Lead sponsor
Mansoura University
Responsible party
Dina Mohamed Hosam Eldin Zaghloul (Clinical Demonstrator, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, Mansoura University) — Principal investigator
First posted
Sep 2, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Mansoura University

Start the discussion