Cleft Lip and PalateNCT05081258
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
A study testing passive Alveolar Molding and Nasoalveolar Molding in people with Cleft Lip and Palate and Unilateral Cleft Lip, run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate, Unilateral Cleft Lip
- What is being tested?
- passive Alveolar Molding and Nasoalveolar Molding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2022to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
- signed informed consent by the parents or legal guardian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Erlangen, Bavaria, 91054
Corinna Seidel, Dr., ++49-09131-85-45667, corinna.seidel@uk-erlangen.de
Lina Gölz, Prof. Dr., ++49-09131-85-33643, lina.goelz@uk-erlangen.de
About this study
Official title: 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.
- Conditions
- Cleft Lip and Palate, Unilateral Cleft Lip
- Being tested
- passive Alveolar Molding, Nasoalveolar Molding
- Keywords
- passie Alveolar Molding, Nasoalveolar Molding, Maxillary Growth, Facial Asymmetry
- Medical subject headings
- Cleft Lip, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive Alveolar MoldingProcedure or surgery
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 MoldingProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| NAM treatment | Active comparator | Study Group: newborns with UCLP will be treated with a palate plate with nasal stent (Nasoalveolar Molding = NAM) Receives: Procedure: Nasoalveolar Molding |
| pAM treatment | Sham comparator | Control Group: newborns with UCLP will be treated with a palate plate without nasal stent (passive Alveolar Molding = pAM) Receives: Procedure: passive Alveolar Molding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From Baseline (after birth) until surgical lip closure (6-7 months of life)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 May 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, longitudinal, randomized, clinical trial
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Corinna Lesley Seidel, University of Erlangen-Nürnberg
- Investigators
- Corinna Seidel, Dr., Study director, Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-NurnbergLina Gölz, Prof. Dr., Study director, Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-NurnbergKarin Strobel, Dr., Study director, Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081258
- Sponsor's protocol ID
- ER-pAM-NAM-UCLP-RCT
- Status last verified
- May 2022
- First submitted
- 4 Aug 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT05081258
- Acronym / sponsor ID
- ER-pAM-NAM-UCLP-RCT
- Conditions
- Cleft Lip and Palate, Unilateral Cleft Lip
- Keywords
- passie Alveolar Molding, Nasoalveolar Molding, Maxillary Growth, Facial Asymmetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, longitudinal, randomized, clinical trial
| Arm | Type | Receives |
|---|---|---|
| NAM treatment | Active comparator | Procedure: Nasoalveolar MoldingStudy Group: newborns with UCLP will be treated with a palate plate with nasal stent (Nasoalveolar Molding = NAM) |
| pAM treatment | Sham comparator | Procedure: passive Alveolar MoldingControl Group: newborns with UCLP will be treated with a palate plate without nasal stent (passive Alveolar Molding = pAM) |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
- signed informed consent by the parents or legal guardian
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive Alveolar MoldingA 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). | Procedure or surgery | pAM treatment |
| Nasoalveolar MoldingA 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). | Procedure or surgery | NAM treatment |
Primary outcome
Columella Deviation Angle
Time frame: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
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
Nostril Width on the cleft side
Time frame: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
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
6 secondary outcomes
Nasal shape
Time frame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
Nasal symmetry
Time frame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
Alveolar cleft width and transversal/sagittal maxillary growth
Time frame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
Alveolar symmetry and rotation of alveolar segments
Time frame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
Statistical and dynamical facial asymmetries
Time frame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
Facial perception
Time frame: From Baseline (after birth) until surgical lip closure (6-7 months of life)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive Alveolar Molding and Nasoalveolar Molding in people with Cleft Lip and Palate and Unilateral Cleft Lip, run by University of Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corinna Seidel, Dr. (++49-09131-85-45667, corinna.seidel@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columella Deviation Angle (time frame: From baseline (after birth) until surgical lip closure (6 - 7 months of life)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.