一种数字化全口义齿的临床疗效评价

目的: 比较计算机辅助设计与制造(computer aided design/computer aided manufacturing,CAD/CAM)技术制作的数字化全口义齿与传统方法制作的全口义齿的临床疗效。方法: 纳入20例无牙颌患者,通过前瞻性、单盲、自身对照临床实验,每人分别采用功能易适性数字化义齿(functional suitable denture, FSD)制作系统及传统方法制作全口义齿。义齿完成后,首先戴用传统全口义齿, 3个月后交换戴用数字化全口义齿。患者于修复前、修复后第2周、第1个月、第2个月、第3个月填写无牙颌口腔健康影响量表-20(oral health impact profile edentulous,OHIP-20E)和义齿满意度视觉模拟评分量表(visual analogue scale,VAS)。于两副义齿戴用后的第3个月,分别进行咀嚼效率测试。结果: 20例患者在戴牙后第3个月,FSD全口义齿VAS评分在总体满意度、易清洁性、发音、美观、稳定、口腔状况这6个方面均值均高于传统全口义齿,而在舒适、咀嚼能力、嚼碎功能这3个方面VAS评分的均值与传统全口义齿基本持平,但差异无统计学意义(P>0.05);FSD全口义齿OHIP-20E评分在各个方面的均值均高于传统全口义齿,其中功能受限、心理不适、总评分这3个方面评分差异有统计学意义(P<0.05);咀嚼效率测量结果为,FSD全口义齿平均咀嚼效率(1.20±0.54)高于传统全口义齿的平均咀嚼效率(1.16±0.53), 差异无统计学意义(P=0.691)。结论: 本研究评价的数字化全口义齿的疗效与传统全口义齿相同,在患者满意度及口腔相关生活质量评价方面都展现出相同的治疗效果。

Evaluation of clinical efficacy of a kind of digital complete denture

Objective: To compare the clinical efficacy of a kind of complete dentures fabricated using computer aided design/computer aided manufacturing (CAD/CAM) workflow with that of the complete denture fabricated using conventional workflow. Methods: Twenty edentulous patients were included in this prospective, single-blind, self-controlled clinical trial. Two pairs of complete dentures were fabricated for each participant: one using the functional suitable denture (FSD) system with CAD/CAM, and the other using conventional fabrication workflow. In the final delivery appointment, the conventional dentures worn by the participant for 3 months at first. Then the participant swapped to wear digital denture for another 3 months. The patients’ satisfaction and oral health related quality of life (OHRQoL) were measured using the visual analogue scale (VAS) and oral health impact profile (OHIP-20E) at baseline, 2 weeks, 1 month, 2 months, and 3 months following denture delivery. In addition, the masticatory efficiency of each pair of dentures was measured after three months adaptation period for each type of dentures. Results: The VAS scores of the twenty patients in FSD denture group on general satisfaction, ease of cleaning, ability to speak, esthetics, stability and oral health status on these six domains were higher than that of conventional denture group 3 months after delivery. While the VAS cores in FSD denture group on comfort, ability to chew and ability to chew up were the same as those of conventional denture group. But there was no significant difference (P>0.05). The VAS score on each domain in FSD denture group was higher than that of conventional denture group 3 months after delivery, three domains of which reached statistical significance (P<0.05), involving functional limitation, psychological discomfort and total. The masticatory performance of the FSD denture (1.20±0.54) was slightly higher than that for the conventional denture (1.16±0.53), but the difference did not reach statistical significance (P=0.691). Conclusion: The clinical efficacy of the FSD complete denture is comparable to that of the conventional complete denture. As for patient satisfaction and oral health related quality of life, FSD dentures received comparable scores as conventional complete dentures did.