Effect of prosthetic management of congenital cleft lip and palate on the middle ear function of infants: A clinical trial

Infants with a cleft palate often experience middle ear disease, a condition of great significance, and early prosthetic management of these infants is essential. However, any correlation between prosthetic palatal obturation and middle ear function is unclear. The purpose of this clinical trial was to assess whether prosthetic palatal obturation with a feeding appliance prevented or improved middle ear problems in infants with a cleft lip and palate. Ten infants with congenital cleft lip and palate (20 ears) were referred to the Prosthodontics department immediately after birth. Assessment of the middle ear function by tympanometry as well as hearing quality by auditory brainstem response (ABR) was conducted before the prosthetic treatment (control readings). The middle ear function and hearing quality was followed up after the prosthetic treatment every month until surgical palatal closure (tenth month). The Friedman test was applied to compare data from the various study periods. When the results were significant, the Dunn post hoc test was conducted to compare the control first week readings with those of the later periods (α=.05 for all tests). The preprosthetic readings of tympanometry in the first week were 90% Type A and 10% Type B for both right and left ears. Readings starting from the first to the fifth month revealed no statistically significant differences compared with the first week readings (>.05). However, tympanometry readings starting from the sixth month (20% Type A and 80% Type B) until the tenth month (90% Type B and 10% Type C) for both ears represented a statistically significant difference compared with the first week readings (≤.05). The preprosthetic readings of ABR in the first week showed that 90% of ears had normal hearing status and 10% had mild hearing loss. Readings starting from the first until the fifth month revealed no statistically significant differences compared with the first week readings (>.05). However, ABR readings starting from the sixth month (20% normal hearing, 70% mild hearing loss, and 10% moderate hearing loss) until the tenth month (0% normal hearing, 80% mild hearing loss, and 20% moderate hearing loss) for both ears revealed a statistically significant difference compared with the first week readings (≤.05). Prosthetic palatal obturation with a feeding appliance plays a role in delaying rather than preventing the occurrence of otitis media with effusion in infants with a cleft lip and palate and could reduce the need for ventilation tubes.