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 Table of Contents  
Year : 2017  |  Volume : 4  |  Issue : 2  |  Page : 114-119

Effect of palatoplasty on hearing ability of nonsyndromic cleft palate patients: A prospective clinical study

1 Department of Trauma and Emergency Medicine, All India Institute of Medical Sciences, Bhopal; Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India
2 Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India
3 Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha; Department of Dentistry, Trauma Care Unit, Government Medical College and Hospital, Nagpur, Maharashtra, India

Date of Web Publication11-Aug-2017

Correspondence Address:
Anuj Jain
Maanvilla, Cement Road, Near Post Office, Savner - 441 107, Dist: Nagpur, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jclpca.jclpca_24_17

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Introduction: Cleft palate patients suffer from many comorbidities, otitis media with effusion being one of them. There is a universal consensus regarding the presence of hearing impairment in such patients. However, there are different schools of thought regarding the effect of palatal repair on hearing ability. Hence, this study was conducted to find out the effect of palatoplasty on hearing ability of children with cleft palate. Patients and Methods: Seventy-five patients with cleft palate underwent palatoplasty and were subjected to otoscopy and brainstem evoked response audiometry, preoperatively, 1 month postoperatively and 6 months postoperatively. The otoscopy and audiometry findings were statistically analyzed using Chi-square test and students unpaired t-test. Results: Ninety-two percent of patients had hearing impairment with majority of them belonging to age group <3 years. The study showed a male preponderance. Statistical analysis revealed that there was no significant difference between the preoperative and 1 month postoperative outcomes of otoscopy and audiometry. However, the values show a statistically significant improvement 6 months postoperatively. Conclusion: There is a marked association between hearing impairment and cleft palate. Moreover, this impaired hearing improves after palatoplasty in due course of time.

Keywords: Brainstem evoked response audiometry, cleft palate, eustachian tube, hearing impairment, otoscopy

How to cite this article:
Jain A, Yadav A, Bhola N, Nimonkar P, Borle R. Effect of palatoplasty on hearing ability of nonsyndromic cleft palate patients: A prospective clinical study. J Cleft Lip Palate Craniofac Anomal 2017;4:114-9

How to cite this URL:
Jain A, Yadav A, Bhola N, Nimonkar P, Borle R. Effect of palatoplasty on hearing ability of nonsyndromic cleft palate patients: A prospective clinical study. J Cleft Lip Palate Craniofac Anomal [serial online] 2017 [cited 2020 May 25];4:114-9. Available from: http://www.jclpca.org/text.asp?2017/4/2/114/212834

  Introduction Top

Developmental anomalies are one of the most frequent aberrations leading to disability and mortality of children worldwide. Cleft lip and/or palate are the most common facial developmental anomalies. Cleft palate patients encounter many difficulties such as feeding problems, dental abnormalities, retarded growth, speech and language disorders as well as hearing impairments. The association between cleft palate and otitis media has been well documented a century ago. It was Alt,[1] who is credited with promulgating this association by describing the presence of otorrhea in a child with cleft palate in 1878. Paradise et al.[2] suggested that middle ear disease probably develops as a universal finding in cleft palate patients.

It has been suggested that otological outcome in these children is improved after palatoplasty, restoring the normal insertion of the palatini muscles into the velopharyngeal sling;[3] however, there is a little controlled evidence to support this. Furthermore, there is evidence of persistent misalignment of the fibers of the Tensor Veli Palatini muscle even after palatoplasty,[4] and the prevalence of the otitis media with effusion (OME) continues to be high in children with cleft palate for many years after the surgery.[5]

To unveil the cover from these conflicts, we have designed this prospective, clinical study with an aim of assessing the prevalence of otological and audiological manifestations in cleft palate children and also evaluating the effect of palatoplasty on the middle ear status of nonsyndromic cleft palate children.

  Patients and Methods Top

A prospective, single-blind, clinical study was conducted in our hospital after obtaining the Institutional Ethics Committee approval. The study included 75 patients within an age range of 10 months to 5 years with cleft palate planned for primary palatoplasty and admitted from August 2013 to December 2015.

Inclusion criteria

  1. Patients who were diagnosed with isolated cleft palate or were previously operated for cleft lip
  2. Patients who were fit for surgery under general anesthesia.

Exclusion criteria

  1. Patients previously operated for cleft palate
  2. Patients whose parents or guardians did not give the consent for inclusion in the study
  3. Patients with previous history of any ear surgery, ventilation tube insertion, grommet insertion, or myringotomy
  4. Patients with possible compromised immune status or systemic disease, craniofacial anomalies, associated syndromes, and delayed achievement of developmental milestones
  5. Patients with any ear pathologies such as tympanic membrane (TM) perforation, cholesteatoma formation, retraction pockets, ossicular fixation, chronic suppurative OME, atelectasis, congenital hearing loss, and congenital auricular malformations.

Patients were shifted to operation theater and were operated under general anesthesia. Once the general anesthesia was induced, the surgical site was prepared using 5% povidone iodine and the patients were draped using sterile sheets keeping only the painted surface exposed. Dingman's mouth gag was secured and epinephrine 1:1,00,000 was injected into the palate before beginning the procedure. All the patients were operated by surgeons having an experience of at least 5 years in cleft surgeries. Depending on the nature of cleft, the type of palatoplasty was chosen. Patients with complete cleft were operated by Bardach's two-flap palatoplasty technique[6] and those with incomplete cleft were operated using Veau-Wardil-Killner palatoplasty.[7] Both the techniques were performed in a highly uniform fashion every time. In all the cases, the mucoperiosteal flaps were raised from the midline, and then, a lateral relaxing incision was made on either side to relieve tension. All the attachments around greater palatine vessels were removed for free movement of palatal flaps. Pterygoid hamulus was fractured to release the tensor veli palatini muscle which winds around the pterygoid hamulus. The erroneous insertions of the velar muscles, mainly tensor veli palatini and levator veli palatini, were dissected and the muscles were reoriented to form the velar muscular sling and sutured with the muscles of opposite side using absorbable polyglactin sutures. Closure in the hard palate region was performed in two layers, i.e., oral layer and nasal layer, using absorbable polyglactin suture material. Both the layers were approximated at a few points to obliterate dead space. Postoperatively, the patients remained in the intensive care unit for 24 h under observation for the development of any possible early postoperative complications. Analgesics and injectable antibiotics were administered.[8]

The patients included in the study underwent otoscopic examination using a Welch Allyn Otoscope® and auditory function evaluation by Brain Evoked Response Audiometry (BERA) preoperatively and 1 month and 6 months postoperatively. Otoscopy was done by the same otolaryngologist who was blinded to the surgical procedure employed. The otolaryngologist observed the condition of TM and documented the findings as normal, dull, retraction, or bulged TM. BERA was performed by a single audiometrist who was also blinded to the surgical procedure, assessed, and documented the degree of hearing impairment as normal, mild, moderate, severe, and profound. For performing BERA, procedure was explained to the parents and the patient was kept in a supine position, relaxing in a sound-attenuated chamber. The patient needed to be sleeping naturally for accurate results if the patient was uncooperative, Syrup Phenargan (Promethazine hydrochloride, 0.5–1 mg/kg/dose) was used to induce sleep. RMS POLYRITE– AD, mark-II, version 2.2 was used to record the evoked potential from the scalp of the patients with silver–silver chloride disc electrodes from standard scalp locations of 10–20 international systems. The scalp was cleaned with alcohol and electrodes were attached using RMS recording paste. The standard electrode montage of left mastoid, right mastoid, forehead, and scalp was used. The skin electrode contact impedance was maintained at 5 K ohms or less. For recording active electrode potential, 2000 click stimuli at the rate of 11.1 Hz with duration of 0.1 ms were delivered at 60 dB above hearing threshold through shielded headphones with-30 dB white noise masking the contralateral ear. Signals were filtered with band pass 100 Hz and 3 KHz and were averaged to 2000 stimuli. Absolute latencies of waves I and V, interpeak latencies of wave I-V, amplitude ratio of wave V-I, and latency intensity function were determined for each ear separately.[8],[9]

All the findings were statistically analyzed applying chi-square test and students unpaired t-test using SPSS software, version 17 developed by IBM, Bangalore, India.

  Results Top

Of the 75 patients included in the study, majority of them (68%) belonged to the age group of 1 to <3 years. The study showed a male preponderance with 69% males and 31% females. [Table 1] shows the diagnosis-wise distribution of study patients with maximum patients (52%) having unilateral cleft palate.
Table 1: Diagnosis wise distribution of study patients

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Otoscopic findings of 150 ears at regular intervals are shown in [Figure 1]. Before palatoplasty, maximum number of ears had dull TM followed by retracted, normal, and bulging TM. Comparison of preoperative otoscopic findings with 1-month postoperative findings revealed no statistically significant difference, whereas when compared with 6 months' postoperative findings, it showed statistically significant improvement (P < 0.05).
Figure 1: Otoscopy findings of patients (preoperative, 1-month postoperative, and 6-month postoperative)

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Audiometry findings revealed that among the 75 patients participated in the study, 6 had normal hearing, 9 had unilateral impairment of hearing, and 60 had bilateral impairment of hearing. Maximum number of ears showed mild response followed by moderate, severe, normal, and profound response before palatoplasty. Comparison of preoperative audiometric findings with 1-month postoperative findings revealed no statistically significant difference, whereas when compared with 6 months' postoperative findings, it showed statistically significant improvement (P < 0.05) [Figure 2].
Figure 2: Brainstem evoked response audiometry findings of patients (preoperative, 1-month postoperative, and 6-month postoperative)

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The otoscopy and audiometry findings in different age group were statistically significant (P < 0.05). However, these findings were statically insignificant in different types of clefts as well as in both genders (P > 0.05). While comparing the otoscopic and audiometric findings of Veau Wardil Killner and Bardach's two-flap palatoplasty, it was found that both the techniques of palatoplasty were found equally effective and no statistically significant difference was seen between the outcomes of the two techniques at 1 month and 6 months postoperatively (P > 0.05).

  Discussion Top

Over the years, the management of cleft lip and palate has been generally taken in the direction of palatal reconstruction and lip repair to achieve cosmetic acceptability and palatal function for speech and deglutition. However, the concern for the aforementioned achievements must not make the surgeons ignore other problems associated with cleft palate. Conductive hearing impairment as a result of middle ear effusion is a common and well-known complication of cleft palate.

In the present study, children with cleft lip were excluded as it has been found that the incidence of hearing impairment in cleft lip alone is the same as in the controlled population, but it increases sharply when there is an associated submucous cleft palate.[10] Due to various problems, such as lack of uniformity of the age of participants in previous studies, lack of age-stratified data available in the literature, and variation in examination methods, principles as well as ethical issues for individuals of different age groups, a specific age group of preschool age children (age below 5 years) was selected for this study.

In the present study, majority of individuals were in the age group of 1 to <3 years. The study also showed a male predilection. These findings are in accordance with the study conducted by Zingade and Sanji.[11] However, sex distribution does not correlate with that reported by Goudy et al.[12] who has reported a female preponderance. Earlier researches have suggested that unilateral cleft lip and palate are more common than bilateral cleft lip and palate as well as isolated cleft palate.[13],[14] Our study is in congruence with these studies as in our study, more than half of the study population had unilateral cleft lip and palate.

Our study delineates the hearing status of children with cleft palate and it confirms earlier reports that hearing impairment is strongly associated with cleft palate. Most of the other researchers found that the percentage of cleft palate patient with associated hearing impairment varies between 23% and 91%.[12],[15],[16],[17],[18],[19] In Indian subcontinent, the prevalence of hearing impairment in cleft palate population was reported to be 76.47% by Khan et al.,[20] 88.38% by D'Mello and Kumar,[13] and 77.77% by Ahmad et al.[21] In our study, we found the prevalence of this association to be as high as 92%. The possible reason for this increased prevalence in our study is that the patients were below the age of 5 years unlike the aforementioned studies and it has been postulated that the likelihood of OME is reduced when this population reaches adulthood as physiologic changes take place in Eustachian tube (ET).[22] In terms of prevalence, our study is in contrast with the study conducted by Narayanan et al.[23] In their study, they reported 22.6% of associated impaired hearing. The reason behind this discrepancy is that in their study, the majority of patients were in the age group of 8–14 years and after 7 years of age, morphological changes occur in ET, leading to the improvement in tubal functions and consequently, improved hearing status.[14]

There is controversy over the appositeness between age of the cleft palate patients and their hearing status. The current study showed that age was significantly related to the hearing status. The hearing impairment of patients <3 years was greater than the patients >3 years of age. This finding acceded with the earlier studies[14],[17],[24] but conflicted with the studies by Narayanan et al.[23] and Chu and Mcpherson[25] reporting that patients' audiologic problems did not ameliorate with age.

The current study exhibited that gender did not significantly influence hearing status. Moreover, there was no evidence that the type of cleft had any statistically significant effect on hearing problems. These findings are in consonance with earlier studies.[11],[24],[25] This offers that ET dysfunction, palatine muscle abnormalities, and middle ear problems may occur irrespective of the type of cleft. There is, however, little agreement regarding the corresponding severity of cleft associated hearing impairment. The literature dealing with this aspect of hearing impairment in cleft palate is sparse.

Of 92% children having impaired hearing in our study, majority of them had a bilateral type of hearing impairment (80%) whereas only nine patients showed unilateral hearing impairment that too in the ear ipsilateral to the cleft. These findings are in agreement with the previous studies suggesting that bilateral hearing impairment is incessant in cleft palate population,[13],[14],[21] but the study piloted by Joyce Heller et al.[18] is in contradiction to this conjecture.

Diagnosis of middle ear effusion can be made based on otoscopic findings. Use of Valsalva maneuver is dubious in this age group due to lack of cooperation from the children. Hence, otoscopy was used as a test of TM appearance and mobility. Otoscopy is sensitive to visually apparent physical changes in the outer ear canal and TM. Regarding otoscopy of patients in our study, 80% ears were chronically affected and only 30 ears were normal with intact pearly white TM with demonstrable landmarks. Dull TM with dearth or absence of mobility suggests OME and a retracted TM suggests ET dysfunction.[26] Air fluid levels or air bubbles were not observed in any ear, suggesting ET pathology as the predominant cause. The studies conducted in the past using otoscopy as diagnostic modality of OME are in assent with our data.[11],[20],[26]

BERA is an electrophysiological assessment method that measures the electrical activity of the auditory system. We performed BERA for our study patients as it is difficult to obtain the cooperation or to examine them considering the age group they belong to.[8] The audiometry findings supported the earlier reports that hearing impairment is one of the associated problems seen in children with cleft palate.[12],[13] Regarding audiometry, our study revealed that 86% ears had some degree of hearing impairment, two-third of them belonging to mild to moderate category and rest, i.e., 12 ears having profound hearing impairment. Other researchers have also found that majority of their patients suffered from mild to moderate hearing impairment irrespective of their test of evaluation.[14],[23],[26] The major pathophysiologic findings of BERA waveforms found in the study patients were temporal shifting of all components along with normal interwave intervals. This indicates the presence of conductive hearing impairment. This finding supported the result of a study carried out by Yang et al.[27]

That One of the contributing factors for high prevalence of TM pathology and hearing impairment in our study is that the majority of children studied were from poor socioeconomic class. Frequent upper respiratory tract infections, crowded and unhygienic living conditions, and poor nutrition are problems faced by such children. These factors also play an important role in the development of chronic middle ear disease.[11]

That OME develops in children with cleft palate is a universally acknowledged fact, but the effect of palatoplasty on the incidence of OME still remains an topic of debate. Lokman et al.[28] from their study concluded that palatoplasty did not influence the incidence of OME. Similarly, Sharma and Nanda[29] inferred that middle ear function may not improve following palatoplasty. Antithetically, other researchers have suggested that the incidence of OME is marginally diminished by palatal surgery.[30],[31] Some other studies expounded that most of the children eventually recover normal ET function following palatoplasty, but this recovery takes a long haul.[32],[33],[34]

The present study demonstrated that there was no statistically significant reduction in the incidence of OME 1 month following palatal repair, whereas 6 months' postoperative results exhibited a statistically significant amelioration in OME postoperatively. Our results are in strong harmony with the outcome of studies executed by Parri et al.[35] and Curtin et al.[36] The reason behind this postoperative improvement of ET function and subsequent diminishing OME must be the detachment of erroneous insertion of velar musculature from bony margins of cleft palate, further making them functional. Another possible contributing factor is that we had performed palatal-lengthening procedure which enriches the velar musculature functioning. Improved functioning of velar musculature subsequently improves the ET function. This improved ET function should be the reason for the amelioration of hearing impairment of children in our study.

When the effect of palatoplasty is in discussion, the technique of palatoplasty definitely comes in the light of questions. In the present study, there is no statistically significant difference between the audiological outcomes with respect to the two techniques. The possible reason behind this would be that both the techniques vary only in the incision given at hard palate region. The procedure of incising and closing in soft palate territory remains similar in both the techniques and the ET functions depend on the velar musculature.

  Conclusion Top

From the present study, we can conclude that the hearing impairment is strongly associated with cleft palate in children and is mostly present in children below 3 years of age. Moreover, the hearing impairment of this children improves after palatoplasty with due course of time, irrespective of the type of cleft.

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Conflicts of interest

There are no conflicts of interest.

  References Top

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Paradise JL, Bluestone CD, Felder H. The universality of otitis media in 50 infants with cleft palate. Pediatrics 1969;44:35-42.  Back to cited text no. 2
Nunn DR, Derkay CS, Darrow DH, Magee W, Strasnick B. The effect of very early cleft palate closure on the need for ventilation tubes in the first years of life. Laryngoscope 1995;105(9 Pt 1):905-8.  Back to cited text no. 3
Boorman JG, Sommerlad BC. Levator palati and palatal dimples: Their anatomy, relationship and clinical significance. Br J Plast Surg 1985;38:326-32.  Back to cited text no. 4
Sheahan P, Blayney AW, Sheahan JN, Earley MJ. Sequelae of otitis media with effusion among children with cleft lip and/or cleft palate. Clin Otolaryngol Allied Sci 2002;27:494-500.  Back to cited text no. 5
Bardach J, Slayer KE. Surgical Techniques in Cleft Lip and Palate. 2nd ed. Chicago, IL: Year Book Medical Publishers; 1991.  Back to cited text no. 6
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Chalak SS, Kale AB, Deshpande VK, Patil CY, Biswas DA, Sawane MV, et al. BERA in detection of hearing loss in children – A Retrospective study of its use in Acharya Vinoba Bhave Rural Hospital. J Datta Meghe Inst Med Sci 2010;5:44-8.  Back to cited text no. 9
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Zingade ND, Sanji RR. The prevalence of otological manifestations in children with cleft palate. Indian J Otolaryngol Head Neck Surg 2009;61:218-22.  Back to cited text no. 11
Goudy S, Lott D, Canady J, Smith RJ. Conductive hearing loss and otopathology in cleft palate patients. Otolaryngol Head Neck Surg 2006;134:946-8.  Back to cited text no. 12
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  [Figure 1], [Figure 2]

  [Table 1]


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