Effects of Khon Kaen University Presurgical Nasoalveolar Molding Device on Maxillary Dimension in Complete Unilateral Cleft Lip and Palate Patients: A Full Protocol Evaluation

Abstract

A prior study reported on maxillary dentoalveolar changes post-application of the full Khon Kaen University Pre-surgical Nasoalveolar Molding device (KKU-PNAM) in complete unilateral cleft lip and palate patients. However, since the KKU-PNAM consists of three separate components, the individual effect of each part is still unclear. The purpose of this study is to determine maxillary dimensional changes after using KKU-PNAM at three time points. The researcher investigated 24 maxillary ridge casts taken from infants with complete unilateral cleft lip and palate were investigated after treatment with the KKU-PNAM at initial treatment (T1), two weeks (T2) and before cheiloplasty (T3). Landmark identification and direct measurements including alveolar cleft width, anterior arch width, mid-palatal cleft width, posterior arch width, anterior arch depth, total arch depth, arch circumference and midline deviation were solely performed by one experienced investigator. Intra-examiner reliability was verified via intraclass correlation (ICC). All measurements were normally distributed, with data analyzed via repeated measure ANOVA. The results showed that the average pre-treatment and post-treatment ages were 16.33±17.36 and 123.21±32.76 days respectively, with mean total treatment time at 105.29±33.98 days. Alveolar cleft width and midline deviation significantly reduced over time from T1 to T3 (p<0.01). Furthermore, arch circumference gradually increased among T1, T2 and T3 (p<0.05). There was no significant difference in anterior arch width, mid-palatal cleft width, posterior arch width, anterior arch depth and total arch depth at T2 and T3 (p>0.05). In conclusion, the severity of alveolar cleft was reduced significantly after the KKU-PNAM was applied at the first two weeks, as the labial taping’s effect further decreased severity by addition of the contraction-screw plate until the point of primary lip surgery, thus improving the position of the maxillary alveolar ridge which brought out better outcomes prior to lip surgical correction.