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

NCT07526272 | Recruiting DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vestibular Socket Therapy; Immediate Dental Implant in Type 2 Extraction Socket

Keywords

VST; Vestibular Socket Therapy; Magnesium Membrane; Type 2 extraction socket; Mg Membrane

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6-months post-operative.

Secondary Outcomes (6)

• Peri-implant soft tissue esthetic outcome

  6-months post-operative.

• Peri-implant mucosal thickness

  Baseline and 6-months post-operative.

• Plaque Index (PI)

  Baseline, 1 month, 3 months and 6 months.

• Gingival Index (GI)

  Baseline, 1 month, 3 months, and 6 months.

• Post-surgical Pain

  At 6, 12, and 24 hours post-operatively, then daily for 7 days.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Immediate implant and VST using cortical lamina.

Procedure: Immediate implant and VST using cortical lamina.

Test Group

EXPERIMENTAL

Immediate implant and VST using magnesium membrane.

Procedure: Immediate implant and VST using Magnesium membrane.

Interventions

Immediate implant and VST using cortical lamina. PROCEDURE

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.

Control Group

Immediate implant and VST using Magnesium membrane. PROCEDURE

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.

Test Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Adel Alfeky: lead

Study Sites (1)

Misr University for Science and Technology

Giza, Egypt

RECRUITING

Central Study Contacts

Mohamed A Alfeky

CONTACT

+201060104208; mohamed.alfeky@must.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: B.D.S. Faculty of Oral and Dental Surgery, Misr University for Science and Technology

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 13, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

EG (1)