Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate implant and VST using cortical lamina., Immediate implant and VST using Magnesium membrane..
- Who it may be relevant to
- Registry conditions: Immediate Dental Implant in Type 2 Extraction Socket, Vestibular Socket Therapy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets: A Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Procedure Immediate 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 xenograf - Procedure Immediate 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
Primary outcome measures
- Bone Volumetric changes [Time frame: Baseline and 6-months post-operative.]
Secondary outcome measures (6)
- Peri-implant soft tissue esthetic outcome [Time frame: 6-months post-operative.]
- Peri-implant mucosal thickness [Time frame: Baseline and 6-months post-operative.]
- Plaque Index (PI) [Time frame: Baseline, 1 month, 3 months and 6 months.]
- Gingival Index (GI) [Time frame: Baseline, 1 month, 3 months, and 6 months.]
- Post-surgical Pain [Time frame: At 6, 12, and 24 hours post-operatively, then daily for 7 days.]
- Patient Satisfaction [Time frame: 6-months post-operative.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Misr University for Science and Technology — Giza
Identifiers
NCT: NCT07526272 · 001