ABSTRACT
Background:
Both cleft lip and palate are among the most common birth defects, significantly impacting individuals and families socially, financially, and psychologically. Understanding the prevalence and patterns of these anomalies is essential for developing targeted healthcare interventions.
Aim:
This study aimed to estimate the prevalence and analyze the patterns of cleft lip and/or palate defects among patients referred to King Khalid General Hospital in Hafer Al-Baten, Saudi Arabia. The findings can help in formulating regional healthcare strategies and guiding policy decisions for better management of cleft cases.
Methods:
This retrospective study was conducted in the Department of Oral Maxillofacial Surgery at King Khalid General Hospital, Hafer Al-Baten. Data of cleft lip and/or palate patients from January 2014 to December 2022 were analyzed. Pearson Chi-square test was used to examine the distribution of cleft cases by year, gender, and side of the cleft.
Results:
The prevalence of cleft lip with or without cleft palate was 0.415 per 1000 live births. Males constituted 56.0% of cases, and females constituted 44.0%, with a mean age of 4.5 (±1.6) months at diagnosis. One-third (33.1%) of cases had cleft palate only, while cleft lip was more common on the left side. Associated congenital anomalies, particularly cardiac diseases, were found in 1.2% of cases.
Conclusion:
Orofacial clefts were more prevalent in males, with left-sided clefts being dominant. The study highlights the necessity of establishing a national registry for cleft anomalies in Saudi Arabia to improve healthcare planning. Further research is required to explore the genetic and environmental risk factors contributing to cleft development.
Keywords: Anomalies, cleft lip, cleft palate, orofacial clefts
INTRODUCTION
Orofacial clefts are the most prevalent craniofacial anomalies worldwide, significantly affecting speech, hearing, appearance, and overall quality of life.[1,2] These congenital defects arise due to incomplete fusion of the lip and palatal structures between the 8th and 12th weeks of gestation.[2] The estimated global incidence is approximately 1 in 700 live births, with variations based on ethnicity, geography, and environmental exposures.[3]
The prevalence of cleft anomalies varies across populations. Studies suggest that Asian and North American populations exhibit higher rates, whereas African populations tend to have the lowest prevalence.[4] Genetic predisposition and environmental influences, including maternal smoking, folic acid deficiency, and teratogenic exposures, play a critical role in cleft formation.[4] Despite the magnitude of this issue, challenges persist in the management of orofacial clefts, particularly in regions like Saudi Arabia. The absence of specialized cleft management centers accentuates the difficulties faced by affected individuals and their families. Additionally, the absence of a universal treatment protocol exacerbates the situation, leading to diverse management approaches by different healthcare providers.
The far-reaching consequences of orofacial clefts necessitate continued research efforts to enhance understanding and treatment outcomes, underlining the significance of exploring this field further.
Research question: What is the prevalence and pattern of cleft lip and/or palate among patients in Hafer Al-Baten, and how do these findings compare to global trends?
This study aimed to estimate the prevalence and patterns of cleft lip and/or palate among the cases presented to a tertiary care hospital, between January 2014 and December 2022. A search of published literature has shown that no previous study has been done to find the patterns of cleft lip and/or palate patients in this region. By shedding light on the specific challenges faced and the outcomes achieved within this context, this research aims to contribute valuable insights to the global discourse on orofacial clefts. Through comprehensive analysis and understanding of disease load and variety of relevant patients, future development can be made toward more effective allocation of resources.
MATERIALS AND METHODS
Approval to conduct the Research was obtained from the Institution Review Boards. The registration number of the research is no. FPG/43636001/39.
From the patient’s records, data were collected on children born with clefts (cleft lip, cleft palate, or both) from January 2014 to December 2022 and treated in the Department of Oral Maxillofacial Surgery. Information regarding the age, sex, date of birth, relation between parents, affected side, and presence of associated major anomalies was recorded in a pre-designed proforma.
Inclusion criteria
All patients with complete records at Department of Oral Maxillofacial Surgery;
Saudi and non-Saudi patients; and
Treated or untreated patients with clefts.
Exclusion criteria
Missed files or incomplete medical records of patients; and
Patients who are temporary residents of Hafer Al-Baten.
The descriptive classification of Veau (1931) to classifying cleft lip and palate was used in this study as shown in Table 1 and Figure 1.[5]
Table 1.
Classification of cleft lip and cleft palate as suggested by Veau
| Group | Description |
|---|---|
| Group I (A) | |
| Group II (B) | |
| Group III (C) | Complete unilateral cleft, extending from the soft palate to alveolus, usually involving the lip |
| Group IV (D) | Complete bilateral clefts, resembles group III but are bilateral. When cleft is bilateral, pre-maxilla is suspended from the nasal septum |
Figure 1.
Veau’s classification, (a) soft palate cleft, (b) soft palate and hard palate, (c) soft/hard palate cleft and alveolus, and (d) soft/hard palate, alveolus, and bilateral cleft lip
Statistical analysis
Data were analyzed using SPSS 20.0 (IBM Corp., Armonk, NY, United States). Qualitative data are presented as numbers and percent. Pearson Chi-square test was used for calculating the distribution of cleft patients by years and cleft distribution by side and gender. A P value ≤ 0.05 was set as a statistically significant value.
RESULTS
The mean (±SD) age of the subjects was 4.5 (±1.6) months ranging from 2 to 12 months. Of the total 166 subjects, 93 (56.0%) were males, and 73 (44.0%) were females. The majority were Saudi nationals (n = 161, 96.9%). Distribution of cleft lip and palate according to consanguinity showed that 113 (68.1%) patients were not related, whereas 53 (31.9%) patients were related. Distribution of the cleft according to congenital anomalies showed only two (1.2%) patients with cleft palate had cardiac diseases. Table 2 shows the distribution of patients according to nationality, gender, consanguinity, and anomalies in cleft patients.
Table 2.
Data according to the nationality, gender, consanguinity, and anomalies in cleft patients (n=166)
| Age | |
| Mean (±SD) | 4.5 (±1.6) |
| Range (in months) | 2-12 |
| Gender | |
| Male | 93 (56.0) |
| Female | 73 (44.0) |
| Nationality | |
| Saudi | 161 (96.9) |
| Non-Saudi | 5 (3.1) |
| Consanguinity | |
| Related | 53 (31.9) |
| Not related | 113 (68.1) |
| Anomalies | |
| Cardiac diseases | 2 (1.2%) (in patients with CP) |
| Others | – |
SD: Standard deviation, CP: Cleft palate
Distribution of patients with cleft by years is shown in Table 3 and Figure 2. The mean frequency of cleft lip and palate deformities was found to be 18.4 cases per year. The highest incidence was noted in 2015 (17.5%, n = 29), and the minimum was in the year 2021 (6.6%, n = 11). However, there was no statistically significant relation (P = 0.18). However, there was no statistically significant relation (P = 0.18).
Table 3.
Distribution of patients with cleft by years (n=166)
| Year | Frequency (n, %) | P |
|---|---|---|
| 2014 | 18 (10.8) | 0.18 |
| 2015 | 29 (17.5) | |
| 2016 | 15 (9.0) | |
| 2017 | 21 (12.7) | |
| 2018 | 24 (14.5) | |
| 2019 | 13 (7.8) | |
| 2020 | 17 (10.2) | |
| 2021 | 11 (6.6) | |
| 2022 | 18 (10.8) | |
| Total | 166 (100.0) |
Figure 2.
Distribution of patients with cleft by years
Cleft distribution by the side is shown in Table 4. Both cleft lip and cleft palate were more likely to be unilateral and on the left side. However, this association was statistically not significant (P = 0.09).
Table 4.
Cleft distribution by side
| Type of cleft | Frequency (n, %) | P | |||
|---|---|---|---|---|---|
|
| |||||
| Unilateral | Bilateral | Total | |||
|
| |||||
| Right | Left | ||||
| CL | 25 (30.9) | 45 (55.6) | 11 (13.6) | 81 (48.8) | 0.09 |
| CLP | 6 (24.0) | 14 (56.0) | 5 (20.0) | 25 (15.1) | |
| CP | – | – | – | 60 (36.1) | |
| Total | 31 | 59 | 16 | 166 | |
CL: Cleft lip, CLP: Cleft lip and palate, CP: Cleft soft and hard palate
Figure 3 shows the distribution of cleft defects among all cases. Approximately one-third (33.1%, n = 55) involved palate only, followed by 27.1% (n = 45) cleft lip left side, 15.1% (n = 25) cleft lip right side, 8.4% (n = 14) cleft lip and palate left side, 6.6% (n = 11) bilateral cleft lip, 3.6% (n = 6) cleft lip and palate right side, 3% (n = 5) bilateral cleft lip and palate, and 3% (n = 5) soft palate only.
Figure 3.
Anatomical location of the cleft. CL-R: cleft lip right side, CL-L: cleft lip left the side, BCL: bilateral cleft lip, CLP-R: cleft lip and palate right side, CLP-L: cleft lip and palate left the side, BCLP: bilateral cleft lip and palate, HPO: hard palate only, SPO: soft palate only
Table 5 shows the distribution of cleft lip and palate according to gender. Males were more likely to have cleft lip left side, cleft lip and palate right side, and hard palate only than females. On the other hand, females were more likely to have cleft lip right side, bilateral cleft lip, cleft lip and palate left side, bilateral cleft lip and palate, and soft palate only than males. However, there was no statistically significant association between cleft deformities and gender (P = 0.11).
Table 5.
Distribution of cleft lip and palate according to gender
| Cleft deformities | Gender | Total (n, %) | P | |
|---|---|---|---|---|
|
| ||||
| Male (n, %) | Female (n, %) | |||
| CL-R | 10 (10.8) | 15 (20.5) | 25 (15.1) | 0.11 |
| CL-L | 31 (33.3) | 14 (19.2) | 45 (27.1) | |
| BCL | 2 (2.2) | 9 (12.3) | 11 (6.6) | |
| CLP-R | 4 (4.3) | 2 (2.7) | 6 (3.6) | |
| CLP-L | 6 (6.5) | 8 (11.0) | 14 (8.4) | |
| BCLP | 2 (2.2) | 3 (3.2) | 5 (3.0) | |
| HPO | 37 (39.8) | 18 (24.7) | 55 (33.1) | |
| SPO | 1 (1.1) | 4 (5.5) | 5 (3.0) | |
CL-R: Cleft lip right side, CL-L: Cleft lip left side, BCL: Bilateral cleft lip, CLP-R: Cleft lip and palate right side, CLP-L: Cleft lip and palate left side, BCLP: Bilateral cleft lip and palate, HPO: Hard palate only, SPO: Soft palate only
DISCUSSION
A total of 166 cases of (59.773) live births (between 2014 and 2022) were included in this study. The incidence was found to be 2.7 cases per 1000 births (1350 cases per 500,000 births). Regarding the prevalence in the study, it was 0.415 per 1000 live births (hospital population around 400,000). A study from Pakistan reported an incidence of 1.91 cases per 1000 births (one per 523 births).[6] Another study reported an incidence of 1/500 to 1/1000, and this variation depends on sex, geographic location, and nationality.[7] A study from Korea reported that the incidence of cleft lip and palate was 1.81/1000 births, estimated at 1 per 554 live births.[8] The prevalence of cleft lip and palate varies depending on sex, race, geographic region, and the cleft type.[9] The order of orofacial cleft birth prevalence in descending order is as follows: Asian, North America, Europe, Oceania, South America, and Africa.[10]
Several previous studies reported a high prevalence of cleft lip and palate as compared to the cleft palate only.[11,12,13] In the current study, the prevalence of cleft lip with or without palate was 0.415 per 1000 live births. Compared to Asian, North America, Europe, Oceania, and South Africa, it is very low.[3,9,10] Two studies from Saudi Arabia were conducted in Riyadh which showed that the prevalence of cleft lip and/or palate was 0.3 births/1000 live births, and this was the lowest prevalence reported.[14,15] In another study from Saudi Arabia, the reported prevalence from Riyadh, Jeddah, and Madinah found that cleft lip was prevalent in 0.47 per 1000 live births, cleft lip and palate was present in 0.42 per 1000 births, while the cleft palate was the least in prevalence, and it was 0.28 per 1000.[4] A study from Jordan reported the prevalence of 2.4 per 1000 live births.[6] Higher prevalence was reported in a study from Uganda, where the prevalence of all Oro-facial clefts was 0.77 per 1000 live births, with a higher prevalence of cleft lip and palate.[16] Other studies reported the same findings,[17,18] while the cleft palate was the least in prevalence.[19] However, according to Mossey et al.,[20] cleft lip with or without palate was more prevalent than cleft lip. The current study showed that cleft lip was the most common, followed by cleft palate and finally cleft lip and palate.
Among gender distribution of orofacial clefts, data showed that males were more affected than females. Our findings were similar to previous reports who discussed gender distribution and orofacial clefts.[9,16,17,18] Regarding the distribution of clefts among genders, both cleft lip and cleft lip with palate were more common in males than in females, while the cleft palate was more prevalent in females. This finding is similar to a study conducted by Aqrabawi[21] where the author showed that all cleft lip cases were males.
Regarding laterality of the orofacial cleft, previous studies show that the ratio of the left cleft, right cleft, and unilateral cleft is 6:3:1.[22,23] Our finding study showed the same ratio. Regarding the side of the cleft lip, in this study, the cleft lip on the left side was the most dominant among all cleft lip cases than the right side cleft. Previous studies have shown that the prevalence of left-sided clefts is twice the prevalence of right-sided clefts and 6-fold that of bilateral clefts.[17,24] One Saudi study reported that the prevalence of left-sided cleft lip with or without palate was higher than that of right-sided.[4] Previous studies have stated that the left-sided unilateral cleft was more common than right-sided.[25,26] However, the reason for the tendency of the left side to cleft is not apparent.[27] It was suggested that the right side might have better hemodynamic perfusion than the left side as fetal head vessels of the right side are close to the heart.[28]
In our study, majority of children’s parents reported that they had no consanguinity. Few of the children had congenital malformations (e.g., cardiac disease). Arab countries have a high percentage rate of consanguinity marriages.[29] The prevalence of consanguineous marriage is high in Saudi Arabia reaching 56% with almost 41% to 60% marriage among first-degree cousins.[30] However, consanguineous marriage was low in our study. Also, it was reported that consanguineous marriage was higher in Madinah than in Jeddah, and this may explain the higher prevalence of cleft lip there.[31] This is similar to findings that there was a higher prevalence of cleft lip and palate than that of cleft lip in countries with low consanguinity.[32,33] An association between cleft palate prevalence and consanguinity was reported by many researchers.[4,30,34,35] Another study reported that there was no definite association between orofacial clefts and consanguineous marriage.[29]
In the present study, the associated frequency of congenital anomalies among our patients with oral clefts was 1.2% (n = 2), with cardiac diseases reported as the most congenital anomalies commonly associated with cleft palate. Congenital cardiac malformation is the most common birth defect. In a healthy population, it occurs between 0.5% and 0.8% in live births. Orofacial cleft and cardiac disease are about 1.3–1.7 per 1000 live births.[36] This finding is similar to previous reports that heart diseases are the most common congenital defect seen in patients with oral clefts.[36,37] However, our finding is not in accordance with a few of the previous studies wherein the authors have reported a higher rate of cardiac heart diseases among cleft patients.[16,38]
The study provides insights into the prevalence and distribution of orofacial clefts in a non-cleft-specialized unit. Given that the data were collected from a general hospital rather than a dedicated cleft care center, the true prevalence in the region may be underestimated. Future research incorporating data from multiple centers, including specialized surgical units, is necessary for a more comprehensive analysis.
Limitations of the study
The following are few of the limitations of this study:
Small sample size;
The study was conducted in only one hospital; and
The lack of plastic surgeons, as well as oral maxillofacial surgeons, and the lack of facilities and equipment in the hospitals in this part of the kingdom compelled many parents to seek treatment for their children outside Hafar Al-Baten city.
CONCLUSION AND RECOMMENDATIONS
In this study, cleft lip was found to be the most dominant among children, and this was more prevalent on the right side. The cleft lip was more common in males, while the cleft palate was more common in females. Cardiac disease was the most common anomaly associated with cleft lip and palate. It is essential to establish a national registry of orofacial cleft anomalies in Saudi Arabia. Additionally, it is recommended to increase awareness of parents about the necessity of this corrective surgery as conditions may dictate. In future, the reasons for variation in prevalence must be elucidated through more rigorous investigations of the epidemiological, geographic distribution, and etiology of the cleft lip with or without palate in the country as a whole and every region using standardized collaborative research.
In summary, further study is required to confirm the pooled prevalence of orofacial clefts among live births in Saudi Arabia. More multicenter studies are needed to understand the genetic and environmental risk factors that impact orofacial clefts. Such studies will facilitate the developing of preventive and control strategies for this congenital malformation. Furthermore, a national registry of orofacial cleft patients should be established for the uniform collection of data and proper allocation of resources for the management of these patients. Given that cleft management involves multiple surgical interventions, this study emphasizes the need for improved surgical facilities and training programs in Saudi Arabia. Strengthening specialized cleft units will help in timely surgical interventions, reducing long-term complications and improving the quality of life for affected individuals.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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