Phase I-IIa clinical trial to evaluate the safety, feasibility and efficacy of the use of a palate mucosa generated by tissue engineering for the treatment of children with cleft palate: the BIOCLEFT study protocol.

Introduction: The current gold standard treatment for patients with orofacial clefts is surgical repair of the palatal defect (uranostaphylorrhaphy), which is associated with growth defects and hypoplasia of the maxillofacial structures. This trial aims to evaluate the potential of a bioengineered artificial palate mucosa, created through tissue engineering with autologous stromal and epithelial cells and nanostructured fibrin-agarose biomaterials, to enhance treatment outcomes for patients with unilateral cleft lip and palate.

Methods And Analysis: This phase I-IIa clinical trial aims to evaluate the feasibility and biosafety of a procedure involving grafting bioartificial palate mucosa onto the areas of denudated bone in patients undergoing uranostaphylorrhaphy.

Usefulness of a Nanostructured Fibrin-Agarose Bone Substitute in a Model of Severely Critical Mandible Bone Defect.

Critical defects of the mandibular bone are very difficult to manage with currently available materials and technology. In the present work, we generated acellular and cellular substitutes for human bone by tissue engineering using nanostructured fibrin-agarose biomaterials, with and without adipose-tissue-derived mesenchymal stem cells differentiated to the osteogenic lineage using inductive media. Then, these substitutes were evaluated in an immunodeficient animal model of severely critical mandibular bone damage in order to assess the potential of the bioartificial tissues to enable bone regeneration.

Long-Term Clinical Study of Implants Placed in Maxillary Sinus Floor Augmentation Using Beta-Tricalcium Phosphate.

Introduction: The aim of this study was to show the long-term clinical outcomes of implants placed in maxillary sinus floor augmentation (MFSA) using beta-tricalcium phosphate (β-TCP).

Patients And Methods: Maxillary patients were diagnosed for MFSA and used beta- β-TCP. After the lateral sinus surgery, implants were loaded at 6 months with restorations.

Generation of a novel model of bioengineered human oral mucosa with increased vascularization potential.

Objective: The aim of this study was to generate novel models of bioartificial human oral mucosa with increased vascularization potential for future use as an advanced therapies medicinal product, by using different vascular and mesenchymal stem cell sources.

Background: Oral mucosa substitutes could contribute to the clinical treatment of complex diseases affecting the oral cavity. Although several models of artificial oral mucosa have been described, biointegration is a major issue that could be favored by the generation of novel substitutes with increased vascularization potential once grafted in vivo.

Transversal Maxillary Distraction in Patients with Cleft Lip and Palate.

Objective: The aim of this study is to describe the importance of osteodistraction with transpalatal distractors for treating transversal maxillary hypoplasia in patients with cleft and lip palate.

Methods: The participants were 17 patients (9 females and 8 males) with cleft lip and palate. Among these, 10 presented unilateral cleft lip and palate, 4 bilateral cleft lip and palate, and 3 cleft palate only.

Impact of Virtual Planning on Surgical Reposition of the Premaxilla Using an Endonasal Approach and Simultaneous Alveoloplasty.

Objective: Describe the surgical repositioning of the premaxilla using an innovative minimally invasive endonasal approach and secondary bone graft at the same time. We want to emphasize the importance of virtual surgical planning in this technique.

Material And Methods: A total of 6 patients with bilateral complete cleft lip and palate underwent a surgical repositioning of the premaxilla.

Nasoalveolar Molding Therapy for the Treatment of Unilateral Cleft Lip and Palate Improves Nasal Symmetry and Maxillary Alveolar Dimensions.

Objective: The aim of this study is to assess the esthetic and morphologic outcomes before surgery using nasoalveolar molding (NAM) therapy in children with unilateral cleft lip and palate.

Design: A prospective analysis was performed.

Setting: The study was carried out in the Congenital Malformations Craniofacial and Cleft Lip and Palate Unit, Hospital Virgen de las Nieves, Andalusian Health Service, Granada (Spain).

Usefulness of a bioengineered oral mucosa model for preventing palate bone alterations in rabbits with a mucoperiostial defect.

The use of mucoperiostial flaps during cleft palate surgery is associated with altered palatal bone growth and development. We analyzed the potential usefulness of a bioengineered oral mucosa in an in vivo model of cleft palate. First, a 4 mm palate defect was created in one side of the palate oral mucosa of 3 week-old New Zealand rabbits, and a complete autologous bioengineered oral mucosa (BOM) or acellular fibrin-agarose scaffold (AS) was implanted.

Generation of a bioengineered autologous bone substitute for palate repair: an in vivo study in laboratory animals.

We carried out an in vivo study to evaluate the potential usefulness of a novel bioengineered bone substitute for the repair of palate defects in laboratory rabbits, using tissue-engineering methods. Our results showed that the use of a bioengineered bone substitute was associated with more symmetrical palate growth as compared to the controls, and the length and height of the palate were very similar on both sides of the palate, with differences from negative controls 4 months after artificial bone grafting for bone length. The histological analysis revealed that the regenerated bone was well organized and expressed osteocalcin.