Regeneration of maxillofacial bone structures is challenging. One strategy for bone damage repair involves using bone filler particles. This study analyzed the regenerative potential of deproteinized bone particles (DP) and collagen-based bone particles (CP) to determine the effectiveness of each biomaterial in bone repair. Structural analysis using scanning electron microscopy and 3D scanning showed that DP and CP were structurally similar, comprising a heterogeneous mixture of bone particles of varying sizes and shapes. Ex vivo analyses, including morphological evaluation, LIVE & DEAD assays, and DNA quantification, demonstrated high biocompatibility of CP and DP with human cells in both direct and indirect contact at 24, 48, and 72 hours. Both particles were grafted onto Wistar rats with a critical mandibular defect for two months. Computed tomography revealed significant defect reduction in the CP group, but not in the DP group, compared to negative controls without any bone particles. Histological analysis showed biocompatibility of both particles in vivo and identified regenerative tissue with collagen fibers and mineralized spots in CP and DP, with more mineralized spots in DP. Histochemistry and immunohistochemistry confirmed collagen, proteoglycans, and osteocalcin presence in the regeneration area of CP and DP. These results confirm the biocompatibility and potential of both particle types for maxillofacial bone regeneration, particularly CP. Future studies should assess their clinical usefulness for patients with cleft palate, mandibular damage, and other maxillofacial applications involving tissue engineering techniques.
Background: Children affected by unilateral cleft lip and palate (UCLP) represent a therapeutic challenge requiring the development of novel therapies, such as the implant of a bioengineered tissue—BIOCLEFT—or the use of nasoalveolar molding (NAM). The objective of this work was to evaluate the effects of NAM on the surgical and aesthetic outcomes of children with UCLP. Methods: A total of 36 children with UCLP treated at a craniofacial malformations management unit were evaluated, including 23 patients treated with presurgical NAM followed by palate surgical correction (NAM group) and 13 patients treated surgically without previous NAM (non-NAM group). Measurements were obtained from each patient immediately before palate surgery, including four linear measurements: nasal ala projection length (NAPL), nasal dome height (NDH), superoinferior alar groove position (S-I AGP), and nasal dome position (M-L NDP), and two angular measurements: columellar deviation (CD) and nasal bridge deviation (NBD). Results: When NAM was used, a significant improvement of the basilar view linear measurements of the patient’s nose was found, including the NAPL and NDH, and the frontal view linear measurement M-L NDP, but not S-I AGP. Significant improvements were also observed in the angular measurements of nasal symmetry CD and NBD. All these variables, except the S-I AGP, significantly correlated with the treatment group, and two variables—NAPL and CD—significantly contributed to generate a predictive model developed using binary logistic regression. Conclusions: These findings support the use of NAM to efficiently improve the nasal symmetry and the presurgical outcomes of patients with UCLP.
Background/Objectives: Patients with cleft lip and palate (CLP) typically experience feeding difficulties due to an abnormal communication between the oral and nasal cavities, and novel therapies such as palate tissue engineering and nasoalveolar molding (NAM) are in need to improve the final outcomes. This study aims to evaluate the parents and caregivers perceptions on the potential of NAM to improve feeding in patients with CLP. Methods: 42 infants with unilateral or bilateral CLP treated with NAM at a reference craniofacial unit were included in the study. Parents or caregivers completed a four-item questionnaire at 3 months of age, before cheiloplasty, evaluating the effects of NAM to improve nasal regurgitation, choking, air swallowing, and feeding time using a 4-point Likert scale. A total perceived feeding benefit score (range 4–16) was calculated. Results: Parents and caregivers perceived a positive effect of NAM to improve choking (3.67 ± 0.53), nasal regurgitation (3.62 ± 0.58), and feeding time (3.50 ± 0.67), while air swallowing showed lower scores (3.19 ± 0.55). The total perceived feeding benefit score was 13.98 ± 1.57, indicating a high perceived benefit. No significant differences were found between males and females or between unilateral and bilateral clefts. Conclusions: Parents and caregivers consistently perceived a beneficial effect of NAM on patients’ feeding. Although further research is required to determine the actual effectiveness of NAM, examining the perspectives reported by parents and caregivers could contribute to understand treatment experiences and guide family-centered care.