Prevalence of Dental Anomalies in Oral Clefts Patients

• Conditions: Anomaly

• Registration Number: NCT05304260
• Lead Sponsor: Cairo University

Brief Summary

To assess the prevalence of dental anomalies in the deciduous dentition in children with oral clefts and to investigate the associated risk factors.

Detailed Description

Oral clefts lip and/or palate are considered as the most common oro-facial defects in children with an unclear complex etiology.

The international prevalence in newborns was estimated as 14 per 10,000 live births worldwide. Around 70% of cases occur as a non-syndromic cleft lip and/or cleft palate (NSCL/P)\], and the resting 30% are associated with Mendelian disorders or teratogenic, chromosomal and sporadic conditions.

Non syndromic cleft lip and/or palate divided into cleft lip (CL), cleft lip and palate (CL/P) and cleft palate (CP) based on epidemiological features and embryologic timing.

The exact etiology is not completely known, but attributed to a mixture of genetic and environmental factors. The usefulness of epidemiological knowledge is important in assessing the burden of oral clefts in order to plan public health resources. Also, knowing the causes of oral clefts, which stimulates research on primary prevention and treatments to improve the quality of health and care.

The incidence of dental defects in cleft patients can be used as clinical indicators for defining cleft sub-phenotypes, as well as providing numbers of instances.

Dental anomalies in children can lead to an increased risk of dental problems from esthetic to orthodontic problems. In Egypt, there is lacking of information on the occurrence of dental defects in the deciduous dentition of children with oral clefts. Also oral clefts are complicated epidemiological condition and further investigations are needed to know about the risk factors of this situation.

Study Timeline

• Study First Submitted: 2022-02-12
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Study Start: 2023-01-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Children with oral cleft lip and/or palate with ages varying from 4 to 6 years.
• Children with primary dentition.
• Parents who accept to participate in the study.
• Compliant children.

Exclusion Criteria

• Healthy children and their guardians
• Syndromic oral clefts children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of dental anomalies	baseline	measurement method: clinical and radiographic examination used to asses prevalence of dental anomalies, unit of measurement binary (yes, no).

Secondary Outcome Measures

Name	Time	Method
Predisposing risk factors for oral clefts	baseline	Measurement method: questionnaire used to assess risk factors of oral clefts, measurement unit: binary questions (yes, no).