Impact of orthodontic molding on newborns with unilateral cleft lip and palate
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial
This study tests if special molding techniques used before surgery can help newborns with unilateral cleft lip and palate grow better and have more balanced faces.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 1 Day to 2 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT05081258 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of presurgical orthodontic molding techniques, specifically passive Alveolar Molding and Nasoalveolar Molding, on the growth and facial symmetry of newborns diagnosed with unilateral cleft lip and palate. The intervention aims to improve breathing, feeding, and the overall maxillary growth of infants by using specialized appliances shortly after birth. By addressing facial asymmetries early on, the study seeks to create optimal conditions for subsequent surgical interventions. The research is conducted at the University Hospital of Erlangen-Nürnberg, focusing on non-syndromal cases of unilateral cleft lip and palate.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns with non-syndromal unilateral cleft lip and palate whose parents or legal guardians can provide informed consent.
Not a fit: Patients with syndromal unilateral cleft lip and palate or those whose guardians cannot ensure adherence to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the facial symmetry and overall development of infants with unilateral cleft lip and palate, leading to better surgical outcomes.
How similar studies have performed: Previous studies have shown promising results with similar orthodontic approaches in improving outcomes for infants with cleft lip and palate, indicating that this methodology is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen, Bavaria
- Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Corinna Seidel, Dr.
- Email: corinna.seidel@uk-erlangen.de
- Phone: ++49-09131-85-45667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.