Prevalence of Dental Anomalies in Oral Clefts Patients

March 22, 2022 updated by: Saada Mohammed Ibrahim El-Aarag, Cairo University

Prevalence of Dental Anomalies in Deciduous Dentition and Risk Factors Associated With Non-syndromic Oral Clefts Patients: A Cross-sectional Study.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Soad Abdel Moneim
  • Phone Number: 01005654355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

oral clefts children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

February 12, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prevalence of dental anomalies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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