Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study (NOVAMAG-2024)

Here is the Detailed Description rewritten following ClinicalTrials.gov guidelines - technical but not duplicating eligibility criteria, outcome measures, or the brief summary:

DETAILED DESCRIPTION Background and Rationale Alveolar ridge reconstruction (ARR) in post-extraction sites with extensive bony wall damage (Class III-IV sockets) represents a significant clinical challenge. Current evidence supports the use of bone substitutes combined with barrier membranes; however, available options present trade-offs. Resorbable collagen membranes lack the mechanical rigidity needed to maintain space in severely compromised defects, while non-resorbable membranes - though structurally stable - carry a higher risk of infection and require a second surgical procedure for removal.

The NOVAMag® membrane (Botiss Biomaterials, Berlin, Germany) is a CE-marked medical device manufactured from pure magnesium metal. It provides mechanical strength comparable to non-resorbable membranes while remaining fully biodegradable. Upon degradation, it releases magnesium ions (Mg²⁺), which are naturally occurring in the human body and have been shown to stimulate cortical bone growth via periosteal stem cells and calcitonin gene-related peptide (CGRP) release from sensory nerve endings. A minor volume of hydrogen gas is also released during degradation, providing slight soft tissue tenting that supports space maintenance. Complete membrane degradation occurs by approximately 16 weeks post-implantation, eliminating the need for surgical removal. Biocompatibility has been previously demonstrated in cardiovascular and orthopedic applications, and preclinical data in a Beagle dog model showed outcomes comparable to collagen membranes for guided bone regeneration.

Study Design This is a no-profit, prospective, single-arm, monocenter pilot interventional study evaluating a post-marketing medical device. The study will be conducted at the Periodontal Unit, Dental Clinic, DIBINEM, University of Bologna, Italy. Given the exploratory nature of the study, no control group is included and no formal hypothesis testing is planned. Ten consecutive eligible patients will be enrolled.

Surgical Procedure All patients undergo cause-related periodontal therapy prior to enrollment until adequate oral hygiene standards are achieved. At baseline, a CBCT scan and intraoral optical scan (3D) are obtained for pre-surgical assessment and reference measurements.

During the surgical session, the compromised tooth is extracted with flap elevation as clinically required. The socket is thoroughly debrided to expose all bony surfaces. The NOVAMag® membrane is then shaped and trimmed to fully cover the bone deficiency. The socket is filled with xenogenic bone substitute (Cerabone plus, Botiss, Germany) up to the crestal bone border. A collagen membrane (Mucoderm, Botiss, Germany) is placed coronally to seal the socket and fixed to the adjacent crestal soft tissues using cross-mattress sutures (6.0 PGA). Intraoperative measurements of alveolar bone dehiscence in height and width, and soft tissue thickness, are recorded.

Postoperative care includes chlorhexidine rinses three times daily until suture removal at 14 days, and antibiotic prophylaxis with Amoxicillin 1g twice daily for 6 days starting the day before surgery (alternative provided in case of allergy).

At 6 months, a second CBCT and intraoral scan are obtained for implant planning (standard of care). During implant placement, bone core biopsies are collected from the drilling waste prior to implant positioning and transferred to 4% formalin solution for histological processing.

Histological and Histomorphometric Analysis Biopsy specimens will be embedded in Technovit 9100 polymer system, dehydrated, and sectioned at 7 µm using a rotation microtome for hard tissue. Sections will be stained with hematoxylin and eosin (H&E) and Movat Pentachrome. Total area scans will be generated by scanning microscopy (M8, PreciPoint) and analyzed using ImageJ v1.53 to quantify the percentage of new bone formation, residual bone substitute, and connective tissue within the implantation area. Analysis will be performed at Berlin Analytix GmbH (Berlin, Germany), provided free of cost by Botiss Biomaterials.

Statistical Analysis Due to the exploratory and descriptive nature of this pilot study, no formal statistical inference will be drawn. All non-missing data will be analyzed. Quantitative variables will be described by mean, standard deviation, standard error of the mean, median, minimum, maximum, and interquartile range. Qualitative variables will be reported as absolute and relative frequencies. Analysis will be performed using IBM SPSS Statistics v20.

Funding and Agreements Study materials (NOVAMag® membrane, Cerabone plus, Mucoderm) are donated free of cost by Botiss Biomaterials GmbH for the duration of the study and used exclusively per manufacturer's instructions. Participant insurance and histological analysis costs are covered by Botiss Biomaterials GmbH. A formal collaboration agreement is in place.