Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
NCT ID: NCT05081258
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
34 participants
INTERVENTIONAL
2022-05-01
2026-11-01
Brief Summary
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Presurgical orthodontic treatment for newborns with UCLP start within the first days after birth to separate oral and nasal cavitiy, to improve breathing and feeding and to regulate growth of the maxillary segments using passive appliances (passive Alveolar Molding (pAM)). An advanced and widely spread concept is the Nasoalveolar Molding (NAM) by Grayson, which was first introduced in 1993 as a palate plate combined with a nasal stent as a non-invasive presurgical appliance to stimulate growth of the nose and use the postnatal potential to modulate the nasal cartilage. The aim of the NAM therapy is to reduce nasal width, to reduce deviation of the columella to the non cleft side and to increase nostril height. However, due to inhomogeneous study designs and results, so far only a slightly positive effect using NAM therapy could be detected and prospective, randomized clinical trials are necessary.
The aim of the study is to analyse and to compare the effects of pAM versus NAM treatment in newborns with UCLP in the first year of life. The following parameters will be analysed on defined study time points: nostril width, nasal morphology, cleft width, maxillary growth, statical and dynamical facial asymmetries and facial perception.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NAM treatment
Study Group: newborns with UCLP will be treated with a palate plate with nasal stent (Nasoalveolar Molding = NAM)
Nasoalveolar Molding
A passive palate plate will be inserted within the first week after birth. A nasal stent will be added to the palate plate after one week (NAM appliance). The NAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and will be treated with a passive palate plate without nasal stent until palate closure (10-12 months of life).
pAM treatment
Control Group: newborns with UCLP will be treated with a palate plate without nasal stent (passive Alveolar Molding = pAM)
passive Alveolar Molding
A passive palate plate (passive Alveolar Molding) will be inserted within the first week after birth. The pAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and the treatment with the pAM appliance will continue until palate closure (10-12 months of life).
Interventions
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passive Alveolar Molding
A passive palate plate (passive Alveolar Molding) will be inserted within the first week after birth. The pAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and the treatment with the pAM appliance will continue until palate closure (10-12 months of life).
Nasoalveolar Molding
A passive palate plate will be inserted within the first week after birth. A nasal stent will be added to the palate plate after one week (NAM appliance). The NAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and will be treated with a passive palate plate without nasal stent until palate closure (10-12 months of life).
Eligibility Criteria
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Inclusion Criteria
* signed informed consent by the parents or legal guardian
Exclusion Criteria
* insufficient adherence and compliance by the parents or legal guardian
* withdrawal of informed consent by the parents or legal guardian
1 Day
2 Years
ALL
Yes
Sponsors
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University of Erlangen-Nürnberg
OTHER
Responsible Party
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Dr. Corinna Lesley Seidel
Orthodontist, Senior Physician
Principal Investigators
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Corinna Seidel, Dr.
Role: STUDY_DIRECTOR
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Lina Gölz, Prof. Dr.
Role: STUDY_DIRECTOR
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Karin Strobel, Dr.
Role: STUDY_DIRECTOR
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Locations
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Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Erlangen, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ER-pAM-NAM-UCLP-RCT
Identifier Type: -
Identifier Source: org_study_id
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