|Year : 2011 | Volume
| Issue : 3 | Page : 105-108
Assessment of middle ear function in patients with cleft palate treated under "Smile Train Project"
Prachi Gautam1, Ravinder Sharma2, Ashish Prakash1, Sanjeev Kumar3, Vivek Taneja2
1 Department of Pediatrics, Subharti Medical College, Meerut, Uttar Pradesh, India
2 Department of ENT, Subharti Medical College, Meerut, Uttar Pradesh, India
3 Department of Oral and Maxillofacial Surgery, Subharti Dental College, Subhartipuram, Meerut, Uttar Pradesh, India
|Date of Web Publication||26-Dec-2011|
46 Saketkunj, Saket, Meerut 250003, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Objective: To evaluate the middle ear function in patients of cleft palate treated under "Smile Train Project". Materials and Methods: Sixty patients (120 ears; 32 male and 28 female) of cleft palate with or without cleft lip were evaluated in pediatrics and ENT OPD in preoperative period. A general medical check up was performed in pediatrics OPD to evaluate the associated craniofacial anomalies. Middle ear function was evaluated in ENT OPD. Otoscopy was done in all patients. Cases under five years of age were evaluated for middle ear function by tympanometry and cases with more than five years of age were evaluated by tympanometry for middle ear function and pure tone audiometry to establish the type of hearing loss. The results are presented as number of ears. Results: A total of 50% of the patients in the study group were in zero- to two-year age group. Otoscopy findings in 120 ears showed that 66.66% of the patients had dull tympanic membrane suggesting a diagnosis of otitis media with effusion. Tympanometry was done in 110 ears, of which, 72.72% of ears had type B tympanogram suggesting otitis media with effusion. Pure tone audiometry in more than five years age group showed that 81.25% ears had conductive hearing loss. Conclusion: This study suggests the need of preoperative ENT check up and audiological assessment in patients of cleft palate undergoing palatal surgery under "Smile Train Project". The association of otitis media with effusion in patients with cleft palate appears strong and a high degree of suspicion for the disease should be kept in them. The anatomical defect and possible causative pathophysiology also supports the inference. Otitis media with effusion causing hearing loss in these patients causes speech delay and unfavorable outcome despite aggressive speech therapy in postoperative period. A co-ordinate team approach of concerned specialists involved in managing these patients would definitely improve their outcome.
Keywords: Cleft palate, Hearing loss, Middle ear, Otitis media with effusion
|How to cite this article:|
Gautam P, Sharma R, Prakash A, Kumar S, Taneja V. Assessment of middle ear function in patients with cleft palate treated under "Smile Train Project". Indian J Otol 2011;17:105-8
|How to cite this URL:|
Gautam P, Sharma R, Prakash A, Kumar S, Taneja V. Assessment of middle ear function in patients with cleft palate treated under "Smile Train Project". Indian J Otol [serial online] 2011 [cited 2020 Jul 6];17:105-8. Available from: http://www.indianjotol.org/text.asp?2011/17/3/105/91186
| Introduction|| |
Cleft lip and palate is one of the most common congenital anomaly. It occurs during the first 12 weeks of gestation. It has a birth prevalence rate ranging from 1/1000 to 2.69/ 1000 amongst different parts of the world.  Basic pathophysiology which contributes to deafness in these children is Eustachian tube More Details dysfunction leading to impaired middle ear ventilation. This can progress to otitis media with effusion (OME), acute suppurative otitis media, and chronic suppurative otitis media.
This study was conducted on patients of cleft palate with or without cleft lip to evaluate the middle ear function in preoperative period. The patients included in the study were treated under "Smile Train Project" for cleft lip and cleft palate. Since the management of middle ear disease is not included in smile train project, we decided to evaluate the middle ear involvement in these patients to identify the severity of problem. The patients included in the study group were subjected to general examination, ENT examination, and audiological evaluation. The results are presented with the review of literature.
| Materials and Methods|| |
The subjects included in the study were cases of cleft palate with or without cleft lip attending Oral and maxillofacial Surgery OPD under "Smile Train Project" at Subharti Dental College and Subharti Medical College (a tertiary care center) from July 2007 to June 2009. These cases were evaluated in Pediatrics and ENT OPD in preoperative period. Cases with isolated cleft lip were not included in the study. A total of 60 patients were included in the study group (32 male and 28 female). For the purpose of analysis, the results obtained were expressed as number of ears.
All the patients were examined in the department of Pediatrics and ENT and findings were noted on a performa. A general medical check up was performed in Pediatrics to evaluate the associated craniofacial anamolies. Thereafter, patients were examined in the department of ENT. Otoscopy was done in all patients with Welsh Allyn Otoscope. Ears with perforation of tympanic membrane and attico antral disease were not subjected to tympanometry.
Cases under age five years were evaluated for middle ear function by tympanometry and cases with more than five years of age were evaluated by tympanometry for middle ear function and pure tone audiometry to establish the type of hearing loss. Tympanometry and Pure tone audiometry were done in a sound treated room. The specification of instrument used is as follows
Pure tone audiometry was done with ALPS advanced digital audiometer AD2000 with telephonics TDH 39 P headphone and oticon A 20 bone conduction vibrator. This was done in 16 cases (32 ears). Tympanometry was done with Impedence audiometer AT235 Interacousticus A/S Assens (Denmark) with universal probe system ATP-AT235U. Probe tone frequency was 226 Hz and probe tone intensity was 85dBSPL. A total of 110 ears were subjected to tympanometry. Four patients with bilateral chronic suppurative otitis media (tubotympanic disease) were not considered for tympanometry. Two patients had attico antral disease in one ear and otitis media with effusion in other ear. Ears with attico antral disease were not considered for tympanometry.
| Results|| |
Majority of the patients were in the age group zero- to two-year age group. Fifty percent of the patients were in the age group, zero- to two-year (of them 16 were male and 14 were female). A total of 26.67% of the patients were in the age group, five to nine years, and 23.33% of the patients were in age group, two to five years [Table 1].
|Table 1: Age and sex distribution in patient with cleft palate ± cleft lip (Number of patients 60) |
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[Table 2] shows the otoscopic findings in 120 ears. Majority of the ears (66.66%) had a dull tympanic membrane. Retracted tympanic membrane was seen in 13.33% of ears and normal tympanic membrane was seen in 11.66% of ears. A total of 1.66% of ears had attico antral disease and 6.66% ears had a tympanic membrane perforation in pars tensa.
|Table 2: Otoscopy findings in patients with cleft palate ± cleft lip (Number of ears 120) |
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The ears with perforation of tympanic membrane and attic cholesteotoma were not subjected to tympanometry. [Table 3] shows the tympanometry findings in 55 ears. A total of 72.72% of ears had a type B of tympanogram suggestive of otitis media with effusion. A total of 10.91% ears showed type C tympanogram suggesting Eustachian tube dysfunction and 16.36% ears showed type A tympanogram suggesting normal middle ear function.
|Table 3: Tympanometry findings in patients with cleft palate ± Cleft lip (Number of ears 110) |
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Cases more than five years of age were also subjected to pure tone audiometry to assess the type of hearing loss. The results of pure tone audiometry in 32 ears are shown in [Table 4]a. Majority of ears (81.25%) showed conductive hearing loss. A total of 18.75% of ears had mixed hearing loss. None of the patient in more than five-year age group had normal hearing or sensorineural hearing loss. The severity of hearing loss was assessed by calculating the pure tone average of threshold of hearing at 500Hz, 1000Hz, and 2000Hz as shown in [Table 4]b. Majority of the ears showed mild (65.6%) to moderate hearing loss (21.8%). A total of 12.5% of ears had moderately severe hearing loss.
| Discussion|| |
Cleft lip and palate are variations of a type of congenital deformity caused by abnormal facial development during gestation. Cleft palate is a condition in which two plates of skull that forms the hard palate (roof of mouth) are not completely formed. Cleft palate can occur as complete (hard palate and soft palate) or incomplete (a hole in the roof of mouth). The basic defect is failure of fusion of the lateral palatine processes, the nasal septum and/or the median palatine processes.
The review of literature showed a prevalence of otitis media with effusion in 84.8% cases of cleft palate.  Holborow  suggested that the tensor palatine muscle is ineffective in its role of opening the nasopharyngeal end of the Eustachian tube. This results in inadequate ventilation of the middle ear and otitis media with effusion results. Roentgenographic study conducted by Bluestone et al,  supported this hypothesis. Shprintzen  conducted fiber-optic nasopharyngoscopy in patients of cleft palate. He suggested hypoplasia of cartilage at pharyngeal end of eustachian tube, small size of opening, and inability to maintain patency during deglutition as the causes of eustachian tube dysfunction.
Clinical examination of ear may suggest the diagnosis of otitis media with effusion. Dull tympanic membrane with decreased or absent mobility suggests the diagnosis of otitis media with effusion. Rarely air fluid level or air bubbles can be seen through a thin tympanic membrane. Goldman  reported that 79% of the 110 patients have otitis media with effusion, retraction pocket, adhesions, and ossicular erosion. Two patients had cholesteotoma. In the present study, majority of the ears (66.66%) had a dull tympanic membrane suggesting otitis media with effusion. A total of 13.33% of the patients had a retracted tympanic membrane suggesting eustachian tube dysfunction. Severied  reported that 7.1% of patients with cleft palate develop cholesteotoma. In our study, 1.66% of ears had attico antral disease and 6.66% ears had a tympanic membrane perforation in pars tensa.
Tympanometry is an objective test to assess middle ear function. It is the gold standard investigation in detecting otitis media with effusion. However, Dhillon  reported that in only 40% of ear tympanometry could be done reliably. In our study, 72.72% of ears had a type B of tympanogram suggestive of otitis media with effusion. A total of 10.91% ears showed type C tympanogram suggesting eustachian tube dysfunction and 16.36% ears showed type A tympanogram suggesting normal middle ear function.
The peak incidence of otitis media with effusion is 10% in five- to seven-year age group. In patients with cleft palate, otitis media with effusion occurs shortly after birth. This is a critical time for acquisition of speech and language. Sustained or fluctuating hearing loss during infancy or early childhood may adversely affect acquisition of language skills. The hearing loss in these cases is usually due to defective conduction, but sensorineural hearing loss has been reported. In our study, majority of ears (81.25%) in more than five-year age group showed conductive hearing loss. A total of 18.75% of ears had mixed hearing loss.
Successful palatal closure does not reduce the likelihood of OME. Hearing loss, especially in language acquisition age, will have detrimental effect on these children. Goldman  suggested early and aggressive otologic management to prevent long term sequele. Masters et al,  observed that adult hearing loss was significantly less in patients in whom palatal repair was done before 17 months of age, especially if the surgery was done with a palatal lengthening procedure. Dhillon  suggested that the incidence of otitis media with effusion is marginally reduced by palatal surgery and Goode T tube provides a satisfactory method for long term middle ear ventilation.
Maheshwar et al,  advocated the use of hearing aid as the first line treatment in 70 patients with repaired cleft palate. He successfully treated 62.9% of the patients with non surgical intervention and showed a low incidence of long term complications in the study group. This appears appealing, but this does not deal with the basic pathophysiology involved in the development of otitis media with effusion in patients of cleft palate. Timmermans et al,  suggested that middle ear function improves as the age progresses. He reported a decrease in otitis media with effusion from 50% to 13% in all ears on the basis of retrospective analysis of 20 patients of repaired cleft palate in 10- to 13-year age group. He further reported tympanic membrane membrane perforation in 13% of cases and retraction of drum in 23% of cases.
Cases with attico antral disease need mastoid exploration and cases with perforation of tympanic membrane need medical treatment and tympanoplasty (at the age of 8-10 years).
Majority of these children are not complaining of hearing loss. A total of 65.6% of the ears in more than five-year age group had mild hearing loss (26-40 dB). These patients are usually from lower socio economic background and uneducated. They are more concerned about facial deformity and overwhelmed by a program offering them free medical treatment for cleft palate and/or cleft lip. The results of speech therapy in these patients after palatal surgery are also compromised with the co-existent hearing loss.
"Smile Train Project" is a big success in developing countries; however, it lacks comprehensive treatment for these needy children. A small child may not complain about ear blockade and hearing loss, but lack of timely intervention can affect his/her language acquisition skills. Preoperative ENT check up can be of great help in these children. This will actually provide a more comprehensive care to these children and the outcome will be better in near future.
| Conclusion|| |
On the basis of this study and the review of literature we suggest
- Mandatory preoperative ENT check up, audiological assessment, and pediatric evaluation in patients with cleft palate. Cases with otitis media with effusion should be identified and a five minute surgical intervention (myringotomy and grommet insertion) before palatal surgery can improve the outcome in these patients. Cases with chronic suppurative otitis media need urgent mastoid exploration to avoid complications. Keeping in mind the success of the "Smile Train Project" and the level of its penetration in the developing countries, there should be a provision for ear care for patients of cleft palate.
- These patients need services of plastic surgeon, oral and maxillofacial surgeon, pediatrician, otolaryngologist, speech therapist, and psychiatrist. Team approach would definitely lead to a favorable outcome in the management of these patients.
| References|| |
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|5.||Shprintzen RJ, Croft CB. Abnormalities of the Eustachian tube orifice in individuals with cleft palate. Int J Paediatr Otorhinolaryngol 1981;3:15-23. |
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|8.||Dhillon RS. The middle ear in cleft palate children pre and post closure. J R Soc Med 1988;81:710-3. |
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[Table 1], [Table 2], [Table 3], [Table 4]