Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate

Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Cleft Lip and Palate; Unilateral Cleft Lip
• Intervention / Treatment: Procedure: Nasoalveolar Molding; Procedure: passive Alveolar Molding

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinna Seidel, Dr.; Phone Number: ++49-09131-85-45667; Email: corinna.seidel@uk-erlangen.de
• Study Contact Backup: Name: Karin Strobel, Dr.; Phone Number: ++ 49-09131 85-33645; Email: karin.strobel@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
      • Contact: Corinna Seidel, Dr.; Phone Number: ++49-09131-85-45667; Email: corinna.seidel@uk-erlangen.de
      • Contact: Lina Gölz, Prof. Dr.; Phone Number: ++49-09131-85-33643; Email: lina.goelz@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NAM treatment; Study Group: newborns with UCLP will be treated with a palate plate with nasal stent (Nasoalveolar Molding = NAM)	Procedure: 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).
Sham Comparator: pAM treatment; Control Group: newborns with UCLP will be treated with a palate plate without nasal stent (passive Alveolar Molding = pAM)	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal shape	The change of the nasal shape from Baseline until one year after surgical palate closure considering different time points. The change of the nasal shape 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 and used for distance (mm) measurements: Subalar point; Subnasal point; Lip Points; ala of the nose; cranial point of the nostril and medial point of the nostril.	From baseline (after birth) until one year after surgical palate closure (24 months of life)
Nasal symmetry	The change of the nasal symmetry from Baseline until one year after surgical palate closure considering different time points. The change of the nasal symmetry 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 and used for angle (°) measurements: Subalar point; Subnasal point; Lip Points; ala of the nose; cranial point of the nostril and medial point of the nostril.	From baseline (after birth) until one year after surgical palate closure (24 months of life)
Alveolar cleft width and transversal/sagittal maxillary growth	The change of the anterior cleft width and transversal/sagittal maxillary growth from Baseline until one year after surgical palate closure considering different time points. The change of the alveolar cleft width and transversal/sagittal maxillary growth will be measured digitally using 3D-scanned models from the maxilla (impressions from the maxilla) and defined anatomical points placed by four raters and used for distance (mm) measurements: pole points; mesial/distal canine points; tuber points and incisal point.	From baseline (after birth) until one year after surgical palate closure (24 months of life)
Alveolar symmetry and rotation of alveolar segments	The change of the alveolar symmetry and rotation of alveolar segments from Baseline until one year after surgical palate closure considering different time points. The change of the alveolar symmetry and rotation of alveolar segments will be measured digitally using 3D-scanned models from the maxilla (impressions from the maxilla) and defined anatomical points placed by four raters and used for angle (°) measurements: pole points; mesial/distal canine points; tuber points and incisal point.	From baseline (after birth) until one year after surgical palate closure (24 months of life)
Statistical and dynamical facial asymmetries	The change of statical and dynamical facial asymmetries from Baseline until one year after surgical palate closure considering different time points. The statical and dynamical facial asymmetries will be measured digitally using 3D-scans of the face performed on 5 time points (1. rest position, 2. between 1 and 3, 3. maximal facial expression, 4. between 3 and 5, 5. final rest position). Defined anatomical an constucted points will be placed by four raters. Measurements will be performed by mirroring scans accordind to a reference plane. Asymmetries are the distances (mm) of the corresponding Points, which would be 0mm in perfect symmetry. The following points will be placed: S = Superciliar Point, Exocanthion; Endocanthion; Zygion; Glabella; Nasion; Pronasale; Subnasale; Pogonion; Subalare; Alare; Cheilion; Labrale superius; Labrale inferius; Crista philtri and Lip Points (median, lateral, corresponding points).	From baseline (after birth) until one year after surgical palate closure (24 months of life)
Facial perception	Facial perception will be rated using 3 pictures photographs / processed photographs of each newborn with UCLP within the first weeks after birth, after insertion of first appliance and until surgical lip closure (without NAM appliance, with NAM appliance, without cleft processed using photoshop). The pictures will be rated from laypersons using a 10-point-rating scale ranging from 1 to 10. 1 = highest attractiveness (greatest positive emotional valance) 10 = least attactiveness / Aversion (greatest negative emotional valence).	From Baseline (after birth) until surgical lip closure (6-7 months of life)

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): November 1, 2026
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Facial Asymmetry; passie Alveolar Molding; Nasoalveolar Molding; Maxillary Growth
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: ER-pAM-NAM-UCLP-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No