Effect of a thin-neck pacifier on primary dentition: a randomized controlled trial.

OBJECTIVES: To evaluate changes in occlusal characteristics in the primary dentition that occur after introducing a thin-neck pacifier (TNP) to children with previously diagnosed pacifier-associated anterior open bite (AOB) and increased overjet. SETTING AND SAMPLE POPULATION: Department of Preventive and Pediatric Dentistry, Jena University Hospital, Germany. Subjects were 86 children (mean age 20.3 months) with a pacifier-associated open bite or overjet >/=2 mm. MATERIAL & METHODS: Randomized controlled trial. Subjects were randomly assigned: group I (n = 28), intervention group using a TNP; group II (n = 30), control group, using a conventional or physiological pacifier; and group III (n = 28), intervention group, Gold standard, weaned off pacifier. Participants were re-examined after 3, 6, 9 and 12 months by an operator, blinded for the treatment. RESULTS: After 12 months data for 63 children (mean age 33.1 months) were analyzed (I: n = 24; II: n = 22; III: n = 17). There was a significant difference between the groups regarding mean overjet (group I: 2.7 +/- 0.5 mm, group II: 3.2 +/- 0.7 mm, group III: 2.4 +/- 0.5 mm, Kruskal-Wallis, p = 0.002) and AOB (group I: -1.2 +/- 0.3 mm, group II: -2.2 +/- 0.3 mm, group III: -0.8 +/- 0.8 mm, Kruskal-Wallis, p < 0.001). The differences between group I and II regarding increased overjet (3.1 +/- 0.2 mm vs. 3.6 +/- 0.3 mm, Mann-Whitney, p < 0.001) and extent of AOB (-1.2 +/- 0.3 mm vs. -2.2 +/- 0.3 mm, Mann-Whitney, p < 0.001) were statistically significant. CONCLUSION: Use of TNP resulted in better clinical measurements for in overjet and overbite compared with the continuing use of conventional or physiological pacifiers.