Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
1 other identifier
interventional
34
1 country
1
Brief Summary
Orofacial clefts are the second most common birth deformity and vary in etiology and phenotype, e.g. isolated cleft palate, cleft lip or cleft lip palate. Especially newborns with unilateral complete cleft lip and palate (UCLP) present severe facial asymmetries auch as a broad and flat ala of the nose, a deviation of the columella and the philtrum to the non cleft side. Since postnatal asymmetries can even remain after surgical lip closure in a alleviated shape, therapeutic presurgical orthodontic approaches to improve symmetrie of the nose and to achieve ideal conditions for lip surgery are essential. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 18, 2022
May 1, 2022
4.5 years
August 4, 2021
May 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Columella Deviation Angle
The change of the Collumella Deviation Angle from Baseline until surgical lip closure. The change of the Columella Deviation Angle will be measured digitally using 3D-scanned models from the nose (scans and impressions from the nose) and defined anatomical points placed by four raters. Sbalc (lNc) = Subalar point on the cleft side Sbalnc (lNnc) = Subalar point on the non-cleft side SN = Subnasal point sn'c (mNc) = Subnasale' point Prn = Pronasal point CDA = Columella Deviation Angle = Angle (°) between the columella axis (connecting line between SN and Prn) and Subalar base line (connecting line between Sbalc and Sbalnc) on the cleft side
From baseline (after birth) until surgical lip closure (6 - 7 months of life)
Nostril Width on the cleft side
The change of the Nostril Width on the cleft side from Baseline until surgical lip closure considering different time points. The change of the Nostril Width on the cleft side will be measured digitally using 3D-scanned models from the nose (scans and impressions from the nose) and defined anatomical points placed by four raters: Sbalc (lNc) = Subalar point on the cleft side Sbalnc (lNnc) = Subalar point on the non-cleft side SN = Subnasal point sn'c (mNc) = Subnasale' point Prn = Pronasal point NWc = Nostril Width on the cleft side = Distance (mm) of the connecting line between Sbalc and sn'c
From baseline (after birth) until surgical lip closure (6 - 7 months of life)
Secondary Outcomes (6)
Nasal shape
From baseline (after birth) until one year after surgical palate closure (24 months of life)
Nasal symmetry
From baseline (after birth) until one year after surgical palate closure (24 months of life)
Alveolar cleft width and transversal/sagittal maxillary growth
From baseline (after birth) until one year after surgical palate closure (24 months of life)
Alveolar symmetry and rotation of alveolar segments
From baseline (after birth) until one year after surgical palate closure (24 months of life)
Statistical and dynamical facial asymmetries
From baseline (after birth) until one year after surgical palate closure (24 months of life)
- +1 more secondary outcomes
Study Arms (2)
NAM treatment
ACTIVE COMPARATORStudy Group: newborns with UCLP will be treated with a palate plate with nasal stent (Nasoalveolar Molding = NAM)
pAM treatment
SHAM COMPARATORControl Group: newborns with UCLP will be treated with a palate plate without nasal stent (passive Alveolar Molding = pAM)
Interventions
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).
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
You may qualify if:
- newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
- signed informed consent by the parents or legal guardian
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Erlangen, Bavaria, 91054, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Corinna Seidel, Dr.
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
- STUDY DIRECTOR
Lina Gölz, Prof. Dr.
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
- STUDY DIRECTOR
Karin Strobel, Dr.
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthodontist, Senior Physician
Study Record Dates
First Submitted
August 4, 2021
First Posted
October 18, 2021
Study Start
May 1, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share