| Objectives1.To explore a more time-efficient and effective digitally assisted three-dimensional measurement method to accurately determine the volume of bone defects in patients with alveolar cleft at the permanent dentition in the Chinese population.We also analyzed whether the volume of the defect in this group of patients correlated with the type of cleft(Cleft Lip with Cleft Alveolar and Palate,CLAP;Cleft Lip with Alveolar Cleft,CLA),location of the cleft,age,and gender.2.A prospective randomized controlled clinical trial was conducted to investigate the feasibility and effectiveness of using autologous bone marrow concentrate(BMC)compounded with β-tricalcium phosphate(β-TCP)as a non-autologous restorative material for the correction of alveolar cleft combined with rectification of secondary lip and nasal deformity.To provide a treatment option of the simultaneous repair of maxillary bone tissue and labial-nasal soft tissue for these patients in the permanent dentition who missed the best time for alveolar cleft repair.3.To establish a stable small porcine alveolar cleft animal model,and to use this animal model for animal experiments on β-TCP repair of maxillary defects.To quantify the osteogenic effect of BMC compounded with β-TCP versus β-TCP alone in the repair of alveolar cleft using digital technology.Methods1.We retrospectively analyzed the preoperative cranial CT data of 100 patients with unilateral secondary deformity of cleft lip with AC in permanent dentition who had missed the optimal timing of bone grafting,and measured them by 2 methods--3D printed model method and modified subtraction method,respectively.Two experienced operators performed the measurements separately,recorded the defect volume and measurement time,compared the accuracy and reproducibility of the two methods.Statistically analyzed the factors associated with the size of the alveolar cleft in this group of patients.2.A total of 40 patients with unilateralsecondary labial-nasal malformation with AC in our hospital between November 2021 and April 2023 were enrolled according to the inclusion and exclusion criteria.These patients were randomly divided into two groups of 20 patients each by the randomized numerical method:group A was the group that underwent secondary deformity of cleft lip repair with simultaneous repair of AC with autologous BMC compounded with β-TCP material.Group B was the group that underwent simple repair of secondary cleft lip deformity.Cranial CT examinations and 3D scans of the face were performed at 6 and 12 months postoperatively.Digital measurement software was used to calculate the newly formed bone mass and measure the osteogenic volume by identifying the preoperative and postoperative 3D images.The outcome of the lip and nose soft tissue repair was assessed by preoperative and postoperative facial 3D scans.3.Construction of 1.5 CM,2.0 CM,and 2.5 CM bone defects between the lateral incisors and cusps of the maxillae of three small pigs with and without localized periosteum disruption,respectively,by means of surgical modeling to determine defect(CSD)size.In addition,we conducted experiments on the repair of maxillary defects with BMC compounded with β-TCP versus β-TCP alone in three bilateral alveolar cleft models,and then performed cranial CT examinations at week 12 and executed them.The osteogenic volume was measured using digital assisted technology to quantify the effect of both methods in repairing alveolar cleft.The osteogenesis of the alveolar cleft was observed by anatomy and histology.Two small pigs with bilateral alveolar crest clefts were used as blank controls.Results1.The mean defect volume measured by the 3D printed model method in this study was 1.58±0.41 CM3,and the mean defect volume measured by the modified subtraction method was 1.55±0.42 CM3.The measurement times for the modified subtraction method and the 3D printed model method were 3.2 and 18.3 min,respectively.Pearson correlation analysis showed that the volumes measured by the two methods showed a strong positive correlation(r=0.984,P<0.05).ICC was between 0.95～0.99(interobserver)and 0.98～0.99(intraobserver),indicating high reliability and reproducibility of the two methods.Independent sample t-tests showed that the mean defect volume was greater in male patients than in female patients,and the defect volume was greater in patients with cleft palate than in patients without cleft palate.Spearman correlation analysis showed that the patient age range(13～42 years)did not affect the AC volume.2.There were no postoperative complications such as infection,bleeding,or hematoma in the group.The mean preoperative defect volume was 0.97±0.34 CM3 in the group of patients with concurrent repair of alveolar cleft and secondary malformation of cleft lip and 1.21±0.40 CM3 in the control group.Paired t-test showed no statistical difference in the size of preoperative defect volume between the two groups.In the experimental group,there was one case of partial implant exposure through the oral vestibule,and the mucosal fissure healed automatically after oral care.The mean value of new bone volume in the experimental group at 6 months postoperatively was 0.27±0.14 CM3,with a BF%of 28.51±5.10%.Good results of soft tissue repair of the lip and nose were obtained in both groups at the 6-month postoperative review.At the 1-year postoperative follow-up,one case in the control group showed recurrence of lip and nose deformity.3.The 1.5 CM group showed bone defect healing at 12 weeks postoperatively with only a localized shallow concave bone defect,regardless of whether the periosteum was disrupted.2.0 CM untreated periosteum group showed significant bone healing at 12 weeks,and the alveolar cleft was found to be incomplete only at the center of the alveolar bone on autopsy.In the 2.0 CM disrupted periosteum group and the 2.5 CM untreated periosteum group,no significant bone defect healing was observed 12 weeks after surgery by CT and surgery.The critical bone defect of maxillary alveolar bone in small pigs was about 2.0CM×2.0CM in size,and a stable animal model of alveolar cleft could be constructed.No significant resorption of the implant was seen on cranial CT at 4 weeks postoperative,and measurements of the cranial CT defect at 12 weeks postoperative using mimics software revealed that the osteogenic percentage BF%was 66.83±3.75%for the concentrated bone marrow blood composite β-TCP repair group and 37.83±5.03%for the β-TCP repair group,P<0.05.Conclusions1.The modified computer-assisted modified subtraction method has good accuracy,consistency,and reproducibility in measuring defect volume,and is faster and more cost-effective than the 3D printed model method.The findings suggest a correlation between cleft type and gender and defect volume in patients with alveolar clefts in the permanent dentition.2.Autologous BMC with β-TCP for the repair of AC via labial incision combined with the correction of secondary labial-nasal malformation is an effective method that can repair both bone and soft tissue deformity of the patient at the same time.3.In this study,a small porcine alveolar cleft model was constructed by surgically creating a maxillary bone defect.We also used digital technology-assisted three-dimensional measurements to quantitatively verify the osteogenic effect of concentrated bone marrow blood compounded with β-TCP in repairing alveolar cleft over β-TCP alone. |
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