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Cleft lip and cleft palate are congenital deformities that occur in the womb. Cleft lip is an abnormal fissure during development that fails to close the lip and leaves an opening or openings at birth. Cleft palate is a fissure or opening at the roof of the mouth or palate. This opening forms a pathway between the mouth and nasal cavities and can cause speech impairment, infection, and breathing difficulty if not treated. Cleft palate may be one side of the roof of the mouth (unilateral), or both sides of the mouth (bilateral). The opening may be complete or incomplete.

The causes are poorly understood but both genetic and environmental factors are at play. With access to more DNA diagnostics, clefts are considered to be more a part of a syndrome. Alcohol and tobacco use by the mother during pregnancy may also play a role. Almost all cases of cleft lip and cleft palate can be treated surgically, although in the developing world, many who are afflicted do not have access to this surgical treatment. Globally, cleft lip and cleft palate pose the largest danger from lack of treatment: dental caries, ear infections, and social stigma. Furthermore, feeding and suckling may be a major issue if not treated.

In the past 20 years, many efforts have been made to record frequency of cleft lip and cleft palate globally, with a lack of results. Many countries have begun major research efforts to seek an accurate incidence and prevalence description as well as any possible genetic/environmental factors that may exist. One of the major goals is also to describe an international classification of cleft lip and cleft palate with help of the World Health Organization (WHO).

There are many parts of the world where the diagnosis, classification, and record keeping of cleft lip and palate are inadequate or inconsistent. This hinders public health efforts to serve areas of greatest need. Specifically, parts of Africa, central Asia, eastern Europe, India, and the Middle East significantly lack resources and healthcare infrastructure to be able to offer solid data to the epidemiology of cleft lip and palate.

It is understood that approximately 7,000 to 8,000 children are born with cleft lip or cleft palate each year in America. This makes cleft lip and palate one of the most common major birth defects in North America. Clefts occur more often in children of Asian, Latino, or Native American descent. It is also more common in males than in females to have cleft lip, while more common in females to have cleft palate.

There are generally three different kinds of clefts: cleft lip without a cleft palate; cleft palate without a cleft lip; or cleft lip and cleft palate together. Bilateral cleft lip is a cleft in both sides of the lip. Complete bilateral cleft lip involves two wide gaps in the upper lip and an opening of the upper jaw. A cleft lip appears as a narrow opening or gap in the skin of the upper lip that extends all the way to the base of the nose. A cleft palate is an opening between the roof of the mouth and the nasal cavity. Some children have clefts that extend through both the front and rear part of the palates, while others have only a partial cleft. The specific classifications and severity of clefts are defined by the WHO.

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