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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Immediate implant and VST using cortical lamina. |
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| Test Group | Experimental | Immediate implant and VST using magnesium membrane. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant soft tissue esthetic outcome | Peri-implant Soft Tissue Esthetic Outcomes will be evaluated at the T1 using the Pink Esthetic Score (PES). The seven variables of the PES (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color, and texture) will be scored from 0 (poor) to 2 (excellent), yielding a maximum score of 14. | 6-months post-operative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed A Alfeky | Contact | +201060104208 | mohamed.alfeky@must.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misr University for Science and Technology | Recruiting | Giza | Egypt |
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| 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. |
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| Peri-implant mucosal thickness | Mucosal thickness will be measured on the mid-sagittal plane as the horizontal distance in millimeters (mm) from the outer surface of the facial bone (or implant surface if bone is absent) to the outer surface of the mucosa at a standardized point, 2mm apical to the free gingival margin. | Baseline and 6-months post-operative. |
| Plaque Index (PI) | Plaque accumulation will be assessed at four surfaces per site (mesio-buccal, mid-buccal, disto-buccal, and lingual) using Silness & Löe plaque index (1964). Scores are assigned on a scale from 0 to 3, where 0 represents no plaque and 3 represents an abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate greater plaque accumulation. | Baseline, 1 month, 3 months and 6 months. |
| Gingival Index (GI) | Gingival inflammation will be assessed at four surfaces per site (mesio-buccal, mid-buccal, disto-buccal, and lingual) using the Löe & Silness Gingival Index (1963). Scores are assigned on a scale from 0 to 3, where 0 represents normal gingiva and 3 represents severe inflammation (marked redness and edema, ulceration, tendency to spontaneous bleeding). Higher scores indicate more severe gingival inflammation. | Baseline, 1 month, 3 months, and 6 months. |
| Post-surgical Pain | Using a 100-mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable"(Huskisson, 1974). | At 6, 12, and 24 hours post-operatively, then daily for 7 days. |
| Patient Satisfaction | using a specifically designed questionnaire evaluating the level of general satisfaction with the outcome of their implant-supported restorations, comfort, speech, esthetics, function, and cleanability.15 Responses were recorded using five-point agreement Likert scale with the five answers options of strongly agree (5), agree (4), I do not know (3), disagree (2), and strongly disagree (1) (Alssum et al., 2025). | 6-months post-operative. |