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The Effect of Infant Orthopedics on the Occlusion of the Deciduous Dentition in Children With Complete Unilateral Cleft Lip and Palate (Dutchcleft) CATHARINA A.M. BONGAARTS, D.D.S. ANNE M. KUIJPERS-JAGTMAN, D.D.S., PH.D.
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  633 The Effect of Infant Orthopedics on the Occlusion of theDeciduous Dentition in Children With Complete Unilateral Cleft Lip andPalate (Dutchcleft) C ATHARINA  A.M. B ONGAARTS , D.D.S.A NNE  M. K UIJPERS -J AGTMAN , D.D.S., P H .D.M ARTIN  A.  VAN  ’ T  H OF , P H .D.B IRTE  P RAHL -A NDERSEN , D.D.S., P H .D. Objective:   Evaluation of the effect of infant orthopedics (IO) ontheocclusionof the deciduous dentition in patients withunilateral cleftlipandpalate(UCLP). Design:   Prospective, two-arm, randomized, controlled clinical trial with threeparticipating cleft palate centers (Dutchcleft). Setting:   Cleft Palate Centers of the University Medical Center Nijmegen, Ac-ademic Center of Dentistry Amsterdam, and Dijkzigt University Hospital Rot-terdam, The Netherlands. Patients:   Children with complete UCLP (n    54) were included. Interventions:   In a concealed allocation procedure, half of the patients wasrandomized to wear a plate till surgical closure of the soft palate (IO  ), andthe other half (IO  ) did not have a plate. Mean Outcome Measures:   Dental arch relationships were assessed at 4 and6 years of age with the 5-year-old index; the Huddart-score;andmeasurementsof overjet, overbite, and sagittal occlusion. Results:   There were no significant differences found between the IO   andIO   groups for the 5-year-old index; the Huddart-score; and overjet, overbite,and sagittal occlusion. Conclusions:   IO had no observable effect on the occlusion in the deciduousdentition at 4 and 6 years of age. Considering the occlusion only, there is noneed to perform IO in children with UCLP. KEY WORDS:  cleft palate, deciduous dentition, dental occlusion, infant ortho- pedics, malocclusion, multicenter, randomized clinical trial, treat- ment outcome  Infant orthopedics (IO) was introduced as a treatment toimprove maxillary arch form and the position of the alar baseto prevent crossbites and to facilitate surgery (McNeil, 1954, Dr. Bongaarts is an orthodontist at the Department of Orthodontics and OralBiology, Dr. Kuijpers-Jagtman is Professor and Chairperson of the Departmentof Orthodontics and Oral Biology and Head of the Cleft Palate CraniofacialUnit, and Dr. van ’t Hof is Professor in Biostatistics in the Department of Preventive and Curative Dentistry, University Medical Center, Nijmegen, theNetherlands. Dr. Prahl-Andersen is Professor and Chairperson of the Depart-ment of Orthodontics, Academic Centre of Dentistry Amsterdam, and Head of the Department of Orthodontics, Dijkzigt University Hospital Rotterdam, theNetherlands.The research is part of the Dutch intercenter study into the effects of infantorthopedic treatment in complete unilateral cleft lip and palate (Dutchcleft),carried out in a collaboration among the Cleft Palate Centers of the Universityof Nijmegen, Academic Center of Dentistry in Amsterdam, and Dijkzigt Uni-versity Hospital in Rotterdam (coordinating orthodontists A.M. Kuijpers-Jagt-man and B. Prahl-Andersen).Submitted April 2003; Accepted November 2003.Address correspondence to: Dr. Anne Kuijpers-Jagtman, University of Nij-megen, Department of Orthodontics, 117 Tandheelkunde, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. E-mail a.kuijpers-jagtman@dent.umcn.nl. 1956). Other advantages reported in the literature are straight-ening of the nasal septum, normalization of the deglutitionprocess, prevention of twisting and positioning of the tonguein the cleft, and better speech development (Hotz and Gnoin-ski,1976,1979; Huddart, 1987; Weil, 1987; Gnoinski, 1990;Gruber, 1990; Kramer et al., 1994; Berkowitz, 1996; Mishimaet al., 1996a, 1996b, 2000; Atack et al., 1998; Johnson et al.,2000b; Konst et al., 2000, 2002, 2003a, 2003b). Disadvantagesmentioned in literature include maxillary growth restriction,negative influences on speech because of delayed palate clo-sure, the costs of the treatment, and its complexity (Pruzanskyand Aduss, 1964; Huddart and Bodenham, 1972; Ross, 1987;Kramer et al. 1992; Prahl et al., 2001).Many different appliances, both active and passive, havebeen described (Berkowitz, 1996). The so-called Zu¨rich ap-proach, using a passive plate of soft and hard acrylic, has hada major influence on treatment by the European cleft teams(Gnoinski, 1990). Studies dealing with the effect of (passive)IO on occlusion show different results. Hotz and Gnoinski(1976, 1979) and Gnoinski (1990) described that there are lessanterior and canine crossbites after presurgical orthopedic  634 Cleft Palate–Craniofacial Journal, November 2004, Vol. 41 No. 6 treatment with the Zu¨rich appliance combined with delayedsurgery, in comparison with their previous treatment proce-dure, which was the McNiel-type orthopedic treatment withconventional surgery. Huddart found good short-term resultsfor the maxillary arch dimensions, when comparing patientstreated with infant orthopedics (IO  ) with patients not treatedwith infant orthopedics (IO  ). However, at the age of 5 yr,the patient groups were comparable with respect to the numberof teeth in crossbite and the severity of the crossbite ( Huddart,1972, 1987; Huddart and Bodenham, 1972). O’Donnell et al.(1974) evaluated the occlusion in the deciduous and mixeddentition of patients treated with IO in terms of crossbite mal-occlusion. A comparison was made with samples of other in-vestigators, some with IO and some without IO. Because of differences in treatment protocol of the samples, the authorsconcluded that a comparison between IO  and IO  could notbe made (O’Donnell et al., 1974). In the Eurocleft studies, thecenters that practice passive presurgical orthopedics did notshow demonstrable advantages in terms of dental relationship.Here also, other differences in treatment protocols betweencenters were present (Shaw et al., 1992a, 1992b; Mars et al.,1992). One of the few studies with a better research designwas conducted by Mishima et al. (1996a, 1996b, 2000). Theinvestigators used a two-group quasirandomized design, inwhich 12 were treated with Hotz plate and eight without. Atage 4 years, they observed larger transverse deciduous canineand second deciduous molar widths for the IO   group, com-pared with the IO   group (Mishima et al., 1996a, 1996b,2000).Because many studies on the effect of IO have a retrospec-tive design, include only a small sample of subjects with uni-lateral cleft lip and palate (UCLP), lack a control group of UCLP children without IO, do not take confounding variablesinto account, or measure only at a certain age, uncertaintyabout the effectiveness of IO remains (Roberts et al., 1991;Mars et al., 1992; Shaw et al., 1992a, 1992b; Winters andHurwitz, 1995; Kuijpers-Jagtman and Long, 2000; Prahl-An-dersen, 2000). Therefore, a prospective randomized clinical tri-al was performed in three cleft palate centers in the Nether-lands, i.e., the Cleft Palate Centers of Amsterdam, Nijmegen,and Rotterdam, to investigate the effect of IO in children withcomplete UCLP (Dutchcleft). The results, until 1 ½  years of age, showed that IO had a temporary effect on the maxillaryarch dimensions, which did not last beyond surgical soft palateclosure (Prahl et al., 2001). Also, it did not prevent collapseof the maxillary arch (Prahl et al., 2003). Evaluation of speechand language development showed that at the age of 12months, the IO   group presented enhanced use of alveolararticulations; however, at the age of 18 months, sound pro-duction in babbling was comparable in both groups (Konst etal., 1999). The speech results at 2.5 years of age showed dif-ferences in intelligibility between the groups. In two differentexperiments, untrained listeners as well as experienced speechand language therapists gave higher ratings to the intelligibilityof the IO   group (Konst, 2002). However, data obtained bya transcription task indicated no differences in intelligibility(Konst et al., 2000). At 2.5 years of age, the phonologicaldevelopment of the IO   children was normal or delayed,whereas most IO   children had abnormal development. Half a year later it appeared that the IO   children had acquiredmore initial consonants than the IO   group (Konst et al.,2003b). In the same age groups, the IO  children used longersentences than the IO   children, indicating that their gram-matical development was more advanced. At the age of 6years, no differences in expressive language skills between thetwo groups were found (Konst et al., 2003a).The purpose of the part of the Dutchcleft trial presented herewas to evaluate the effect of IO on the occlusion of the decid-uous dentition in children with UCLP, aged 4 and 6 years. Thehypothesis to be tested is that the occlusion is not differentbetween the IO   group and the IO   group. M ETHODS A detailed description of the experimental design, treatmentassignment, treatment protocol, and operators used in thisstudy can be found in Prahl et al. (2001). A summary of themost important issues is given below.The study was designed as a prospective, two-arm, random-ized, controlled clinical trial in the Cleft Palate Centers in Nij-megen, Amsterdam, and Rotterdam, The Netherlands. The lo-cal ethical committees approved the study protocol. The inclu-sion criteria were complete UCLP, infants born at term, bothparents Caucasian and fluent in the Dutch language, and trialentrance within 2 weeks after birth. The exclusion criteria weresoft tissue bands and other congenital malformations. Figure1 shows the follow-up until the age of 6 years, with the reasonsfor exclusion of evaluation. When the parents agreed to par-ticipate in the study, they were asked to provide informed con-sent. Between 3 and 6 months of age, all included childrenwere checked by the geneticist of their own cleft lip and palate(CLP) team as being nonsyndromic. Treatment Half of the patients were treated with IO by means of pas-sive plates until surgical soft palate closure (n  27), and half did not receive a plate (n    27). The plates were made on aplaster cast using compound soft and hard acrylic. The IO  children had their plates adjusted every 3 weeks to guide themaxillary segments by grinding at the cleft margins; maxillarygrowth and emergence of deciduous teeth indicated the neces-sity for a new plate. After surgical lip closure, the plate wasreplaced the same day. Checkups were planned every 4 to 6weeks following lip surgery. The plate was maintained untilsoft palate closure. The IO  group visited the clinic at 6 weeksand before and after lip surgery and soft palate closure. Inboth groups, lip surgery was performed at the age of 18 weeksby the Millard technique; soft palate surgery was performedat the age of about 52 weeks according to a modified VonLangenbeck method. In the studied age period (until 6 yearsof age), other interventions were performed if indicated: pha-  Bongaarts et al., EFFECT OF INFANT ORTHOPEDICS IN UCLP 635 FIGURE 1 Flow diagram of trial children with the reasons for exclusionof evaluation. TABLE 1 A Listing of Features to Be Assessed on the StudyModels of the 5-Year-Old Index* 1 (excellent)Positive ( normal or enlarged  ) overjet with average inclined orretroclined incisors.No crossbites/  crossbite tendency of 1 or 2 teeth in the smaller segment  .No open bites or vertical steps around the cleft site.Good maxillary arch shape and palatal vault anatomy.2 (good)Positive overjet with average inclined or proclined incisors.Unilateral crossbite/crossbite tendency  of the whole smaller segment  .Open bite tendency around cleft site.  Edge to edge in the front without crossbites in the lateral segments .3 (fair)Edge-to-edge bite with average inclined or proclined incisors.Reversed overjet with retroclined incisors.Unilateral crossbite.Open bite tendency around cleft site.4 (poor)Reversed overjet with average inclined or proclined incisors.Unilateral crossbite/bilateral crossbite tendency.Open bite tendency around cleft site.5 (very poor)Reversed overjet with proclined incisors.Bilateral crossbite.Poor maxillary arch form and palatal vault anatomy. * Italic text represents features that were adjusted in the srcinal index. ryngoplasty (n  22), lip revision (n  13), facial mask treat-ment (n    1), plate to improve speech (n    15), and closureof the anterior palate (n    6). These extra interventions areequally distributed over the IO   and the IO   group. Data Acquisition To evaluate the occlusion, impressions were taken at ages 4and 6 years. In Nijmegen the impressions were made withCavex CA 37 (Cavex Holland BV, Haarlem, The Netherlands);in Amsterdam with Lastic (Kettenbach Dental, Eschenburg,Germany); and in Rotterdam with Tetra-chrom (Kaniedenta,London and Mu¨nchen). Plaster casts were then fabricated. Toeliminate bias, the examiners were able to identify neither chil-dren nor the cleft palate center the models came from. There-fore, all models were duplicated and trimmed in the same way.The dental arch relationship was assessed on the study mod-els using the 5-year-old index (Atack et al., 1997a, 1997b).This index categorizes arch relationships of patients withUCLP using reference models. The method is comparable withthe Goslon Yardstick, used for the late mixed and early per-manent dentition (Mars et al., 1987). A pilot examination wasdone by four observers with 10 casts. It appeared necessaryto adjust some rules within the srcinal index because manycasts were categorized between 1 and 2 or 2 and 3. The ad- justments are shown in Table 1. Three examiners, experiencedin cleft lip and palate, and one less experienced examiner, as-sessed all casts twice. For the second scoring, the sequence of the casts was changed to minimize memory effects.The overjet and the overbite were measured to the nearestmillimeter with Korkhaus divider at the central incisors of thenoncleft side on the casts. The overbite was calculated as apercentage of the length of central lower incisor of the noncleftside.The sagittal occlusion was scored for the deciduous caninesand second deciduous molars according to the Angle classifi-cation. Class I occlusion was scored as zero; Classes II and IIIocclusions were scored in premolar widths. A quarter premolarwidth was scored as 1, half a premolar width was scored as 2,three quarter premolar width was scored as 3, and a full pre-molar width was scored as 4. A positive sign meant Class IIand a negative sign meant Class III (Heidbu¨chel and Kuijpers-Jagtman, 1997). The scoring system is described in Table 2.Huddart’s scoring system was used to evaluate the severityand location of crossbites. A score, as shown in Figure 2, isgiven to each tooth in relation to its antagonist. The lateralincisors are not assessed because they are often missing at thecleft side. If another tooth is missing, it will be scored as themean of the scores of the neighboring teeth. The sum of thescores of all teeth forms the Huddart score (Huddart, 1972;Huddart and Bodenham, 1972; Heidbu¨chel and Kuijpers-Jagt-man, 1997).To assess the inter- and intraobserver agreement for the  636 Cleft Palate–Craniofacial Journal, November 2004, Vol. 41 No. 6 TABLE 2 Sagittal Occlusion Scoring System* Score Meaning  4  3  2  11 premolar width ¾  premolar width ½  premolar width ¼  premolar widthClass II0 Class I  1  2  3  4 ¼  premolar width ½  premolar width ¾  premolar width1 premolar widthClass III *    Angle class II;     Angle class III; 0    Angle class I. Every point differencecorresponds with one fourth premolar width difference in occlusion. FIGURE 2 Huddart’s scoring of transverse dental relationship. overjet, overbite, sagittal occlusion, and Huddart’s score, allmeasurements at age 4 years were done twice by two exam-iners. Statistical Analysis For intra- and interexaminer agreement of the 5-year-oldindex, weighted kappas were calculated at 4 and 6 years of age. Cronbach’s alpha was calculated as the reliability coeffi-cient of the mean 5-year-old index score, for 4 and 6 years of age.For the overjet, overbite, sagittal occlusion according to An-gle (overall, cleft side, and noncleft side), and the crossbitescore according to Huddart (overall, cleft side, and non-leftside), intraexaminer error (duplicate error) was calculated for4 and 6 years of age. The interexaminer error and the corre-sponding reliability coefficient (Pearson correlation coeffi-cient) were calculated at the age of 4 years.To test the differences between IO  and IO  at ages 4 and6 years and for the increment, Student’s  t   tests were used. R ESULTS General At intake, 54 patients participated in the study. An overviewof the sample characteristics is given in Table 3. Two IO  children hardly used the plate, and in one case the plate wasmistakenly worn until 78 weeks. These children remained inthe IO   group based on the intention-to-treat principle. The
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