RecruitingNot ApplicableNCT07526272

Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets

Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets: A Randomized Controlled Clinical Trial


Sponsor

Mohamed Adel Alfeky

Enrollment

24 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Inclusion Criteria3

  • 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.

Exclusion Criteria4

  • 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.

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Interventions

PROCEDUREImmediate 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.

PROCEDUREImmediate 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.


Locations(1)

Misr University for Science and Technology

Giza, Egypt

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NCT07526272