|Year : 2014 | Volume
| Issue : 1 | Page : 26-33
Clinical profile and treatment status of subjects with cleft lip and palate anomaly in India: Preliminary report of a three-center study
OP Kharbanda1, Karoon Agrawal2, Rakesh Khazanchi3, Suresh C Sharma4, Sushma Sagar5, Manish Singhal5, Neeraj N Mathur6, Kumud Kumar Handa7, Madhulika Kabra8, Neerja Gupta8, Neeraj Wadhwan9
1 Department of Orthodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India
2 Department of Burns, Plastic and Maxillofacial Surgery, Safdarjung Hospital, New Delhi, India
3 Department of Plastic, Aesthetic and Reconstructive Surgery, Medanta The MEDICITY Hospital, Gurgaon, Haryana, India
4 Department of ENT, All India Institute of Medical Sciences, New Delhi, India
5 Department of Surgery, All India Institute of Medical Sciences, New Delhi, India
6 Department of ENT, Safdarjung Hospital, New Delhi, India
7 Department of ENT, Medanta The MEDICITY Hospital, Gurgaon, Haryana, India
8 Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
9 Senior Research Officer, ICMR, New Delhi, India
|Date of Web Publication||5-Feb-2014|
O P Kharbanda
Department of Orthodontics and Dentofacial Deformities, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi - 110 029
Source of Support: The project was fully supported by grant from the ICMR, New Delhi.: ICMR headquarters: Dr. DK Shukla and Dr. Ashoo Grover., Conflict of Interest: None
Context: Treatment of patients with cleft lip and palate (CLP) anomaly requires a multidisciplinary approach from birth until adulthood. Many children with cleft anomaly are born in rural areas where resources for treatment and awareness on cleft care are limited. Consequently, many patients may receive limited or suboptimal care due to multitudes of reasons. Aims: The current study was aimed to record the baseline data on the spectrum of clinical profile of cleft patients, treatment protocols, quality of treatment and the residual treatment needs of patients with CLP anomaly visiting three major hospitals across Delhi and National Capital Region (NCR). The experience gained from the three-center study would be used to lay a framework to conduct a nationwide multicenter study in terms of logistics, feasibility and difficulties. Materials and Methods: The study titled "CLP anomaly in India: Clinical profile Risk factors and current status of treatment: A hospital based study" was started in 2010 as a Task Force project of Indian Council of Medical Research. The Pilot phase, which started in 2012, encompassed three cleft centers across Delhi and NCR, namely, All India Institute of Medical Sciences, Safdarjang Hospital and Medanta - The Medicity. Data for 126 non-syndromic CLP subjects was recorded on a specially designed performa. Each case was evaluated by a team of specialists comprising of a Plastic Surgeon, an Orthodontist, ENT Surgeon, Dental Surgeon, Speech therapist and an Audiologist. Clinical records included profile and intraoral photos, dental study models, audiometric and speech evaluation data. The current paper attempts to highlights a few of relevant observations of the pooled data from three centers. Results and Conclusions: The results indicate a lack of uniform protocol followed in providing care to cleft patients. A great variation was found in the quality of treatment received by many of the patients.
Keywords: Cleft lip and palate, GOSLON yardstick, malocclusion, hearing defects, hypernasality, multicentric study, oral fistula, speech intelligibility, velopharyngeal insufficiency
|How to cite this article:|
Kharbanda O P, Agrawal K, Khazanchi R, Sharma SC, Sagar S, Singhal M, Mathur NN, Handa KK, Kabra M, Gupta N, Wadhwan N. Clinical profile and treatment status of subjects with cleft lip and palate anomaly in India: Preliminary report of a three-center study. J Cleft Lip Palate Craniofac Anomal 2014;1:26-33
|How to cite this URL:|
Kharbanda O P, Agrawal K, Khazanchi R, Sharma SC, Sagar S, Singhal M, Mathur NN, Handa KK, Kabra M, Gupta N, Wadhwan N. Clinical profile and treatment status of subjects with cleft lip and palate anomaly in India: Preliminary report of a three-center study. J Cleft Lip Palate Craniofac Anomal [serial online] 2014 [cited 2019 May 22];1:26-33. Available from: http://www.jclpca.org/text.asp?2014/1/1/26/126550
| Introduction|| |
Cleft lip and palate (CLP) is the most common congenital deformity of the craniofacial region  with an average world-wide incidence of 1 in 700.  Its incidence in Asian population is reported to be around 2.0/1000 live births or higher.  In India, though national epidemiological data is not available, many studies from different parts have reported a variation in the incidence of cleft anomaly. Sidhu and Deshmukh reported the incidence of CLP (CL + P) at All India Institute of Medical Sciences (AIIMS), New Delhi to be 1.4/1000 live births.  Mossey and Little  estimated from various studies across India that the incidence of CLP in India to be around 0.93-1.3.
Based on rough estimates, it is suggested that approximately 35,000 newborn cleft patients are added every year to Indian population.  With many patients having less than optimum care in a not so organized setup, cumulative burden of persons affected with this birth defect is huge. Although India has a large and extended network of medical facilities, interdisciplinary cleft care is provided in only a few hospitals. Day-to-day interactions with these patients revealed significant variation in treatment provided and quality of outcome with some having had excellent treatment outcome while many more patients having received suboptimum, limited or no treatment. The reasons are many and varied. The awareness in the society and amongst the health professionals on critical aspects of interdisciplinary care of this anomaly maybe lacking.  Affordability and availability of experts may also contribute to the quality of treatment. Gopalakrishna and Agrawal  following a national survey on trends in the management of patients with CLP in India concluded: "Management of CLP differs in India. Primary surgical practices are almost similar to other studies. There is a lack of an interdisciplinary approach in the majority of the centers and hence, there is a need for better interaction among the specialists." This lack of an interdisciplinary approach and the need for it in the Indian setup has been stressed previously also.  This ongoing taskforce project was initiated by the Indian Council of Medical Research (ICMR), to evaluate the current status of treatment and treatment needs of cleft patients. The ultimate aim is to work out a national registry and guidelines for cleft care in India.
| Aims and Objectives of the Project|| |
0Back ground and organization of the project
A multidisciplinary, multicenter project " CLP anomaly in India: Clinical profile Risk factors and current status of treatment: A hospital based study" was initiated under the aegis of ICMR, New Delhi. This huge project has been split into three phases: Pre-pilot, Pilot and a National Project. The pre-pilot phase was successfully completed in the Department of Orthodontics and ENT, AIIMS, New Delhi (2010-2012) and was aimed to assess the feasibility of a larger pilot study.
The pilot phase is essentially aimed to evaluate the socio-economic and demographic details of patients with CLP (visiting the three enrolled hospitals), their treatment profile and the residual treatment needs. The report of the Pilot Phase would be the basis to formulate a nationwide multicenter study aimed to:
- Identify pattern of the congenital birth defects of face, CLP in India.
- Establish the baseline data of spectrum of problems of cleft patients, protocols of treatment given to these children and their actual treatment needs.
- Ascertain risk factors associated with congenital birth defects of face: Nutritional, environmental and genetic.
- Develop strategies to minimize risk factors thereby reduction in the incidence of CLP anomaly.
- Develop protocols for interdisciplinary care which is feasible and affordable in India.
- Improve treatment outcome.
The long-term objectives are to initiate a National Registry for patients with congenital birth defects of the face and jaws and guidelines of treatment thereof.[/TAG:2]
| Subjects and Methods|| |
The pre pilot phase
This phase of study was conducted at the Department of Orthodontics and Dentofacial Deformities, Center for Dental Education and Research (CDER) and ENT, at the AIIMS, New Delhi, from April 2010 to March 2012. The key highlights were:
- An exhaustive study tool was developed which has seven sections. The multidisciplinary clinical examination was to be performed by following specialists. Surgeon/Plastic Surgeon, Orthodontist, Dental Surgeon, ENT specialist and Speech therapist.
- Standard operating procedure for recording the extraoral and intraoral clinical photographs, dental study models and investigations on hearing defect and evaluation of speech were developed.
- Planning was carried out to extend the project into the other hospitals across Delhi.
The pilot phase
The pilot phase of the project was focused on high volume cleft care centers in Delhi and National Capital Region (NCR) which involved two public funded and one private hospital namely, AIIMS, Safdarjang hospital and Medanta - The Medicity. At each of the centers, the Departments of Plastic Surgery, Orthodontics and ENT constituted major think tank teams to support and coordinate the study. The study was carried out by the specifically designated Indicleft Team*. Organizational setup of the project is as shown in [Figure 1].
The record making for the cases involved prior consent and approval. Each patient inducted in the study was subjected to the following investigations, all of which were non-invasive type.
- Evaluation of the patient using the specially fabricated performa developed during the prepilot phase of the project. The performa evaluated the following aspects of cleft care:
- General details: The personal details like patients name and address, contact details were recorded.
- Socio-demographic profile.
- Evaluation of the risk factors associated with etiology of cleft.
- Dental status of cleft patients and their orthodontic treatment profile.
- Evaluation of primary and secondary cleft deformity.
- Assessment of tympanic membrane.
- Hearing and speech evaluation.
- The patients' extra oral and intraoral standard clinical photographs were recorded.
- Study models of each patient above 5 years of age were prepared using alginate impression material.
The complete list of the parameters studied in the project is long and is beyond the scope of discussion in this paper. Here, only a few of the parameters used to evaluate the secondary cleft deformity are discussed (the detailed performa can be provided on request to the corresponding author).
In total, 126 cases with CLP anomaly were recorded from three hospitals involved in the project (50 from AIIMS, 36 from Safdarjang, 40 from Medanta). The sample consisted of 79 males and 47 females with a wide age distribution (1 month to 451 months; mean 110 months) [Figure 2] and [Figure 3]. Among the males, the majority of the cases belonged to the unilateral cleft lip and palate (UCLP; 43 cases) category followed by bilateral cleft lip and palate (BCLP; 20 cases). Among the females, 17 cases had UCLP, 9 had BCLP while 12 cases had a cleft palate (CP) [Figure 4].
|Figure 2: Distribution of sample according to age and sex for patients less than or equal to 6 years|
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|Figure 3: Distribution of sample according to age and sex for patients more than 6 years|
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The cleft deformity was evaluated by a plastic surgeon. Cases with primary and secondary cleft deformities were evaluated on separate parameters. Cases with secondary cleft deformity were assessed for the overall lip appearance, overall appearance of the nose, presence of palatal fistula and function of the soft palate. Overall lip appearance was judged on the basis of the lip symmetry, thickness of the vermilion border, presence of crosshatches across the scar line and the width (length of the scar). The lips were classified as poor repair, fair, good, very good and excellent.
The appearance of the nose depended upon the nasal symmetry, deviation of the tip of the nose and nasal septum, length of the columella, width and symmetry of the alar bases, among other factors. The nose repair was classified as poor repair, fair, good, very good and excellent.
The length of the soft palate was judged subjectively by asking the patient to open the mouth wide and say "aaaahhhh" repetitively while observing the elevation of the soft palate during this maneuver. The soft palates were classified as short or adequate in length.
Assessment of tympanic membrane was done by an ENT surgeon using an otoscope. The tympanic membranes were classified as normal, retracted or perforated. In each patient, both ears were examined irrespective of the side or type of cleft. In cases with an intact tympanic membrane, assessment of hearing was done in both ears using a combined pure tone and impedance audiometry unit (Interaccoustics, USA). The cases were classified according to the presence or absence of hearing loss and the type of hearing loss, i.e., conductive, sensorineural and mixed type.
Speech assessment was done by a speech therapist and each subject was assessed for hypernasality and overall speech intelligibility. Assessment of hypernasality was subjective and classified as present or absent. Speech intelligibility was assessed using a standardized scale [Table 1].
|Table 1: Rating scale used for assessment of Speech Intelligibility for native language|
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The orthodontic treatment need was assessed using GOSLON Yardstick according to the criteria defined by Mars et al.  and grouped into categories 1-5 [Table 2].
| Results|| |
The data was huge and its detailed analysis, especially the association of cleft with etiologic risk factors, are beyond the scope of this paper. Only the most pertinent and significant findings of clinical profile are being reported here.
Age at primary lip and palatal surgery
Primary lip surgery
Of the 126 cases, 105 cases had a cleft of lip, of which only 88 were included for analysis (one unoperated case at 14 years; 14 awaited surgery; two did not have adequate records). For the remaining 88 cases, the age of primary surgery of lip varied considerably between 2 months to 60 months [Figure 5]. Nearly half of the operated cases received primary lip surgery after 6 months of age.
|Figure 5: Distribution of the cases according to the age at primary lip surgery|
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Primary palatal surgery
Out of the 126 cases, 109 cases had a cleft of the palate, of which 83 were included for analysis (5 cases remained unoperated [Table 3]; 18 awaited surgery; 3 did not have records). The 83 cases showed a large variation in timing of the palatal surgery varying from 4 months to 78 months [Figure 6].
Majority of cases were operated between 7 months to 22 months (median: 18 months).
|Figure 6: Distribution of cases according to age at primary palatal surgery|
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|Table 3: Cases that remained unoperated for primary palatal surgery beyond 18 months of age|
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Presence of post-surgical palatal/alveolar fistula
Out of 126 cases, 109 cases had cleft of palate. Of these 86 were included for analysis (23 unoperated). Of the 86 cases, 46 had a residual fistula while 40 did not have a fistula. Among those with fistula, the highest percentage of cases (76%) had a perialveolar fistula.
Overall appearance of lip and nose
Of the 126 cases, 105 cases had a cleft of lip, of which 90 received primary lip surgery. Amongst these 90 cases, 37 cases (41%) were judged to have a good/excellent outcome of the lip surgery while 26 cases (29%) had a poor surgical outcome. These 26 cases were expected to have "definite requirement" for lip revision surgery in future [Table 4].
Of the 126 cases, 80 were included for analysis (20 cases of CP; 26 partially/completely unoperated). Of the 80 cases, 28 cases (35%) were judged to have a poor appearance of nose while good/very good outcomes were seen in only 27 cases (33%) [Table 5].
Length of soft palate
Out of the 126 cases, 109 cases had a cleft of palate. Of these, 78 cases were selected for analysis (5 unoperated [Table 6]; 18 awaited surgery; 8 cases uncooperative). Amongst the 78 cases, 42 (54%) were deemed to have a short soft palate while 36 (46%) had adequate palatal length.
Orthodontic treatment needs
Orthodontic treatment needs and complexity of orthodontic treatment was assessed using Goslon Yardstick.  Goslon rating was carried on a group of UCLP (n = 29) patients on the basis of the criteria defined by Mars et al.  [Table 2]. The findings revealed that 13 out of 29 cases fell in Goslon category 3, 10 in Goslon category 4 and only 5 cases in Goslon category 2 while 1 case belonged to category 5 [Figure 7].
Hearing and tympanic membrane assessment
A total of 70 cases could be assessed for detailed ENT evaluation (56 cases were young, inadequate cooperation). Out of the 70 cases, 42 cases (60%) showed problems with hearing ability in at least one of the ears while 28 cases (40%) had a normal hearing ability in both the ears, as evaluated using impedance and pure tone audiometry. The details of the type of hearing loss and concomitant tympanic membrane afflictions would be discussed in a separate article.
Only 71 cases could be evaluated for status of tympanic membrane. Amongst these, 31 (43.6%) had normal tympanic membrane on both sides while 40 (56.3%) cases had a retracted or perforated tympanic membrane in at least one of the ears.
Hypernasality and Speech intelligibility
Only 71 subjects could be assessed for hypernasality as the remaining subjects were too young. The data revealed that only 12 cases (17%) had normal nasality while 59 (83%) had significant hypernasality in their voice. Majority of these 59 cases belonged to the UCLP, BCLP and CP groups.
Of the 70 patients who could be evaluated, only 8 (11.4%) had intelligible speech [Figure 8]. If patients in categories 1 or 2 are considered to have only minor speech intelligibility defects, 42 cases (60%) could be said to have clinically acceptable speech. The remaining 28 (40%) cases had significant speech intelligibility problems [Figure 8].
|Figure 8: Speech intelligibility in the sample as a function of type of cleft. Within each category of intelligibility rating, contribution of each type of cleft is shown in different colors. The vertical length of each color coded bar shows the percentage contribution by each category of cleft|
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| Discussion|| |
The comprehensive management of CLP anomaly requires interdisciplinary care right from birth up to adulthood. In India, several influences affect the quality of care delivered to cleft patients. This may include lack of awareness and education, socio-economic factors, demographic factors, availability of expert centers and logistics of delivery of care amongst others.
This three center pilot phase of ICMR funded Task Force project was undertaken to assess feasibility and difficulties encountered in undertaking such a study across India and to establish a protocol for the same. This report is focused to highlight the current treatment profile and the residual treatment needs of patients with cleft anomaly visiting the three prominent cleft care hospitals across Delhi and NCR.
The data analysis of cases pooled from the three centers exhibited significant variation in the timings and outcome of surgery, complexity of orthodontic treatment and speech and hearing defects. It is pertinent to mention that the cases recorded at each of the centers were a mix of those who had their treatment at their respective center and those cases which were treated elsewhere but were referred/sought further treatment. Hence the results of this pooled data do not necessarily reflect the treatment outcome of the center alone or combined. They only reflect the quality of care which many of the cleft patients in our society end up receiving.
Data revealed that nearly half of the operated cases received lip surgery after 6 months of age while the median age for palatal repair was 18 months (range 4-78 months). This range is quite wide and deviates significantly from the Oslo protocol. For the primary palatal surgery, Oslo protocol recommends 3-6 months for lip and anterior palate surgery and 18 months for soft palate closure  while the American Cleft Palate and Craniofacial Association protocol recommends up to 12 months of age for lip surgery and 18 months for palatal surgery.  Our observations are somewhat similar to those documented earlier from India. Bhateja et al.,  in a hospital based study, reported that age at primary lip surgery varied from 4-24 months (mean 14.4 months) while the age at primary palatal surgery varied between 11-48 months (mean 29.7 months). Agrawal found that only 43.62% cases received primary surgery before 2 years in a Sub-Himalayan village based population.  Data from the Smile Train in India also revealed that median age of primary cleft surgery was 2.55 years. 
The evaluation of the nose, lip and the soft palate was aimed to document the need for secondary surgeries to correct the lip deformity, the nasal deformity, both of which could be affecting the esthetic and functional outcome of the treatment. In our sample, 29% cases needed lip revision for acceptable clinical outcomes while 35% cases required nose revision. This is a rather large proportion of cases that would need secondary surgeries. The palatal length was judged to be short in 49% cases which could possibly lead to significant velopharyngeal incompetence and hypernasality. The results are similar to Bhateja et al. who found that 76% of their cases required upper lip revision and all the cases need nose revision (age range: 9-18 years). 
The outcome of the primary cleft surgeries on the maxillo-mandibular growth can be evaluated using the Goslon yardstick. Goslon yardstick essentially evaluates the sagittal maxilla-mandibular dental arch relations and reflects in part the effect of surgeries on the sagittal growth of maxilla. It also reveals the complexity of the orthodontic care anticipated. In our study, 55% cases had complex orthodontic treatment needs; of which 38% cases required combined orthognathic surgery and orthodontic treatment. Bhateja et al.  in their study have reported that 40% of their cases required combined orthodontic and orthognathic procedures. Similar figures were also reported by Jena et al. 
The presence of a post-surgicalpalatal fistula can lead to many adverse consequences like nasal intonation of voice, recurrent ENT infections, nasal regurgitation of liquids and speech impairment. In our sample, a high percentage of cases (53.5%) had a post-surgical fistula. In the existing literature, the rate of oronasal fistula (ONF) has been reported to vary between 4% and 35% respectively  or more, following primary palatoplasty. Very few studies report the incidence/prevalence of post-surgical palatal fistula in cleft patients in the Indian setup. Bhateja et al.  had reported a 100% presence of fistula in a small hospital based sample the 25 cases. The presence of fistula could have multiple reasons including a wide primary cleft,  inappropriate surgical technique, post-operative complications and wound dehiscence, among others.
Tympanic membrane affliction is common in cleft patients due to defective eustachian tube function  which may contribute to increased incidence of middle ear infections resulting in possible adhesions and loss of hearing ability. In our sample, a high proportion of patients had hearing defects (60%) and many of these also had concomitant tympanic membrane afflictions also (56.3%), in one or both the ears. D'Mello and Kumar  also reported a high incidence of hearing defects in their samples. Afflictions of the tympanic membrane like retraction and perforation require immediate attention and intervention to prevent development of conductive hearing loss in the future.
Many patients with cleft anomaly also have related speech problems like hypernasality, articulation defects and delayed development of expressive language, especially slower acquisition of sounds and words and restricted inventory of sounds in early infancy.  It has been suggested that the key to addressing this problem is detecting the problem early and prescribing speech therapy at an early age by training the mother to deliver the intervention.  In our sample, the speech afflictions were found to be high with as many as 40% cases having clinically relevant speech intelligibility problems. The nasalance values were even higher with 83% cases having hypernasality of speech. In a study in South India, Nagarajan et al.  found that 43% cases exhibited abnormalities in articulation and resonance while 12% had only articulation deviations which affected the speech.
Thus, it is evident that patients with cleft anomaly tend to develop multitude of problems including surgical, dental, orthodontic, hearing and speech, to name a few. The findings of the pooled data of recorded from three centers across NCR highlight the need for improvement in quality of cleft care. It is clear that the outcomes in this sample of patients are way behind those seen in some of the good European centers like Copenhagen and Oslo. 
The current pilot project was primarily aimed at establishing a protocol for a larger multicenter study and its logistic operative feasibility. The road ahead includes the expansion of the project Pan India with inclusion of multiple centers representing the different regions of the nation. It is obvious that to make this study truly representative of the population, we would have to make changes in the study design.
| Summary and Conclusions|| |
The current study reports treatment outcome of 126 CLP patients pooled from three centers. The key observations of the study included:
- Wide variation in age at primary lip (range 2-60 months) and palatal surgery (4-78 months) was noted.
- A significant percentage of cases required lip and nose revision surgeries (29% and 35% respectively) while 53.5% cases had a post-surgical oro nasal fistula.
- Fifty five percent of the operated UCLP cases had complex orthodontic treatment needs.
- A high proportion of patients had hearing defects (60%) and many of these also had concomitant tympanic membrane afflictions also (56.3%), in one or both the ears.
- 40% cases had clinically relevant speech intelligibility problems.
Thus, it can be concluded that in the sample of cleft patients assessed in the project, the residual treatment needs were high. There seems an urgent need to devise strategies to improve the delivery of quality care with joint efforts of all experts and health care providers.
OP Kharbanda (CDER AIIMS), SC Sharma (ENT AIIMS) Karoon Agrawal (SJ Hospital), Rakesh Khazanchi (Medanta The MEDICITY Hospital), Mathur NN (ENT SJ Hospital) Handa KK (ENT, Medanta Hospital), S Sagar (Plastic Surgeon AIIMS), M Singhal (Plastic Surgeon AIIMS) M Kabra, N Gupta (Clinical Genetist AIIMS), Neeraj Wadhawan (CDER AIIMS) U Venaik, P Narang (Dental Surgeons), P Rathod (Speech Therapist).
The project was fully supported by grant from the ICMR, New Delhi.: ICMR headquarters, NCD: Dr. DK Shukla and Dr. Ashoo Grover.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]