RecruitingNCT02639312

Natural History of Craniofacial Anomalies and Developmental Growth Variants


Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Enrollment

2,400 participants

Start Date

Apr 18, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Some head and facial abnormalities are rare and present at birth. Others are more common, and may not show up until puberty. These conditions have different causes and characteristics. Researchers want to learn more about these conditions by comparing people with face, head, and neck abnormalities to family members and to healthy volunteers without such conditions. Objectives: To learn more about abnormal development of the face, head, and neck. To determine their genetic variants. Eligibility: People who have not had surgery for facial trauma: People ages 2 and older with craniofacial abnormalities (may participate offsite) Unaffected relatives ages 2 and older Healthy volunteers ages 6 and older Design: Participants will be screened with medical history and physical exam focusing on head, face, and neck Participants may be followed for several years. Visits may require staying near the clinic for a few days. A visit is required for the following developmental stages, along with follow-up visits: Age 2-6 Age 6-10 Age 11-17 Age 18 and older Visits may include: Medical history Physical exam Questionnaires Oral exam Blood and urine tests Cheek swab: a cotton swab will be wiped across the inside of the cheek several times. Cone beam CT scan (CBCT): x-rays create an image of the head, face, teeth, and neck. Participants will stand still or sit on a chair for about 20 minutes while the scanner rotates around the head. Photos of the head and face Offsite participants will provide: Copies of medical and dental records Leftover tissue samples from previous surgery Blood sample or cheek swab


Eligibility

Min Age: 2 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study examines the natural history of craniofacial anomalies — differences in the development of the face, skull, and jaw — across a wide range of ages and conditions. By collecting genetic information and imaging data, researchers aim to understand what causes these anomalies, how they change over time, and how to better treat them. Both affected individuals and healthy volunteers serve as comparison subjects. You may be eligible if: - You are between 2 and 100 years old (or a family member of someone with a craniofacial condition) - You have a diagnosed craniofacial anomaly (for the subject group), or are an unaffected family member, or are a healthy volunteer without craniofacial conditions - You (or a legal guardian) can provide informed consent - For healthy volunteers: you are at least 6 years old and have no personal or family history of craniofacial conditions You may NOT be eligible if: - You have a history of facial trauma requiring surgical reconstruction - You refuse both genetic testing AND CBCT imaging (you must agree to at least one) - For healthy volunteers: you are a pregnant or nursing female Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02639312


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