Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG · Oct 4, 2021
Trial Information
Current as of August 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how two different types of presurgical orthodontic treatments—passive Alveolar Molding (pAM) and Nasoalveolar Molding (NAM)—affect the growth and development of newborns with unilateral cleft lip and palate (UCLP). These treatments aim to improve the symmetry of the face and nose, which can help with breathing, feeding, and preparing for future surgery. The researchers want to compare how well each method works during the first year of life by looking at changes in the nose and face, as well as overall growth.
To participate in this study, newborns and infants with non-syndromal UCLP can be included if their parents or legal guardians give their consent. However, babies with syndromal UCLP or those whose parents cannot follow the study requirements will not be eligible. Participants can expect to have their facial features monitored at specific times throughout the year to assess the effectiveness of each treatment. This study is currently recruiting participants, and it aims to provide clearer information on the best approach to improve outcomes for babies with this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
- • signed informed consent by the parents or legal guardian
- Exclusion Criteria:
- • newborns/infants with syndromal (s) unilateral cleft lip palate (UCLP)
- • insufficient adherence and compliance by the parents or legal guardian
- • withdrawal of informed consent by the parents or legal guardian
About University Of Erlangen Nürnberg
The University of Erlangen-Nürnberg, a prestigious institution in Germany, is dedicated to advancing medical research and clinical innovation. With a strong emphasis on interdisciplinary collaboration, the university conducts a wide range of clinical trials aimed at improving healthcare outcomes and developing novel therapeutic strategies. Its commitment to scientific excellence is reflected in its robust research infrastructure, expert faculty, and state-of-the-art facilities, enabling the university to contribute significantly to the field of medicine and to foster the translation of research findings into practical applications for patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Erlangen, Bavaria, Germany
Patients applied
Trial Officials
Corinna Seidel, Dr.
Study Director
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Lina Gölz, Prof. Dr.
Study Director
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Karin Strobel, Dr.
Study Director
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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