- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940389
Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches (PSIO)
Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches: A Parallel-arm Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdallah Bahaa, M.Sc.
- Phone Number: +2 01114084090
- Email: abdallahbahaa000@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Infants with 0 (after birth) to 1 month of age
- Non-syndromic with no other medical conditions
- Unilateral complete cleft lip and palate
- Cleft width > 5 mm
Exclusion Criteria:
- Syndromic UCLP or bilateral cleft lip and palate
- Incomplete UCLP
- Cleft width ≤ 5 mm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NAM appliance Group
The NAM appliance is constructed according to the Grayson technique [8] with the nasal stent added from the start.
The adhesive paste is used to hold the alveolar plate in place and labial taping is used.
Patients are followed each 2 to 3 weeks for the appliance to be relined and selectively ground to modify the pressure as needed.
The surgical lip repair technique involved will be done by one surgeon using the Delare technique without the blind dissection of the alar cartilage.
|
The NAM appliance is constructed according to the Grayson technique [8] with the nasal stent added from the start.
The adhesive paste is used to hold the alveolar plate in place and labial taping is used.
Patients are followed each 2 to 3 weeks for the appliance to be relined and selectively ground to modify the pressure as needed.
Other Names:
|
Experimental: Taping with nasal elevator:
For the lip approximation, Airoplast tape is used which is water resistant transparent and coated with hypoallergic adhesive on one side. The nasal elevator is 3D printed from the design inspired by the Dynacleft nasal elevator. Patients will be followed each 2 to 3 weeks for any modifications or adjustments. The surgical lip repair technique involved will be done by one surgeon using the Delare technique without the blind dissection of the alar cartilage. |
For the lip approximation, Airoplast tape is used which is water resistant transparent and coated with hypoallergic adhesive on one side.
The nasal elevator is 3D printed from the design inspired by the Dynacleft nasal elevator.
Patients will be followed each 2 to 3 weeks for any modifications or adjustments.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nasal tip projection
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the nasolabial angle by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
change in Columella height
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the linear distance (mm) from the subnasal point to the labral superiors point by the superimposition of the 3D facial scans at different time points (T0, T1, T2,T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in projection alar length
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the linear distance (mm) from the most anterior point of the affected nasal ala to the deepest point at the base of the nose by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in width of the nostril
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the linear distance (mm) from the most lateral point of the affected nasal ala to the most medial point of the affected ala by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in nasal basal width
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the linear distance (mm) from the most lateral point of the affected nasal ala to the most medial point of the affected ala at the level of the nasal base by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in the angle of the columella
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the columella-labial angle by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in cleft lip segment
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the width (mm) of the labial cleft segment from the most lateral point to the most medial point at the widest area of the labial cleft by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in the height of the non-cleft lip
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the non-affected lip height (mm) from the subnasal point to the labral superior point by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in the height of the cleft lip
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the affected lip height (mm) from the subnasal point to the labral superior point by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the alveolar cleft width
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the alveolar cleft width (mm) from the most lateral to the most medial points at cleft edges by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in arch perimeter
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Observing the change in the arch perimeter (mm) from the most left and right posterior points by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in greater segment perimeter
Time Frame: T0= before Intervention, T1= after 1 month, T2= after 6 months, T3=after 1 year
|
observing the change in the greater segment perimeter (mm) from the most posterior point to the most anterior point at the cleft edge by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1= after 1 month, T2= after 6 months, T3=after 1 year
|
Change in lesser segment perimeter
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the lesser segment perimeter (mm) from the most posterior point to the most anterior point at the cleft edge by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in posterior width of the palatal cleft
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the posterior cleft width (mm) at the primary molars' gum pads by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in arch width at the anterior region
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the anterior arch width (mm) at the primary canine gum pads by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in greater segment rotation
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the angle between the greater segment and midsagittal plane by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2,T3 and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in lesser segment rotation
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the angle between the lesser segment and midsagittal plane by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Change in arch width at the posterior region
Time Frame: T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
observing the change in the posterior arch width (mm) at the primary molars' gum pads by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4)
|
T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Grayson BH, Santiago PE, Brecht LE, Cutting CB. Presurgical nasoalveolar molding in infants with cleft lip and palate. Cleft Palate Craniofac J. 1999 Nov;36(6):486-98. doi: 10.1597/1545-1569_1999_036_0486_pnmiiw_2.3.co_2.
- Padovano WM, Skolnick GB, Naidoo SD, Snyder-Warwick AK, Patel KB. Long-Term Effects of Nasoalveolar Molding in Patients With Unilateral Cleft Lip and Palate: A Systematic Review and Meta-Analysis. Cleft Palate Craniofac J. 2022 Apr;59(4):462-474. doi: 10.1177/10556656211009702. Epub 2021 Apr 22.
- Wadde K, Chowdhar A, Venkatakrishnan L, Ghodake M, Sachdev SS, Chhapane A. Protocols in the management of cleft lip and palate: A systematic review. J Stomatol Oral Maxillofac Surg. 2023 Apr;124(2):101338. doi: 10.1016/j.jormas.2022.11.014. Epub 2022 Nov 21.
- Saad MS, Fata M, Farouk A, Habib AMA, Gad M, Tayel MB, Marei MK. Early Progressive Maxillary Changes with Nasoalveolar Molding: Randomized Controlled Clinical Trial. JDR Clin Trans Res. 2020 Oct;5(4):319-331. doi: 10.1177/2380084419887336. Epub 2019 Dec 20.
- Abd El-Ghafour M, Aboulhassan MA, Fayed MMS, El-Beialy AR, Eid FHK, Hegab SE, El-Gendi M, Emara D. Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial. Cleft Palate Craniofac J. 2020 Dec;57(12):1370-1381. doi: 10.1177/1055665620954321. Epub 2020 Sep 10.
- Chang CS, Wallace CG, Pai BC, Chiu YT, Hsieh YJ, Chen IJ, Liao YF, Liou EJ, Chen PK. Comparison of two nasoalveolar molding techniques in unilateral complete cleft lip patients: a randomized, prospective, single-blind trial to compare nasal outcomes. Plast Reconstr Surg. 2014 Aug;134(2):275-282. doi: 10.1097/PRS.0000000000000361.
- Abd El-Ghafour M, Aboulhassan MA, El-Beialy AR, Fayed MMS, Eid FHK, El-Gendi M, Emara D. Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants With Unilateral Cleft Lip and Palate? A Randomized Controlled Trial. Cleft Palate Craniofac J. 2020 Dec;57(12):1382-1391. doi: 10.1177/1055665620944757. Epub 2020 Aug 10.
- Abd El-Ghafour M, Aboulhassan MA, El-Beialy AR, Fayed MMS, Eid FHK, Emara D, El-Gendi M. Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1300e-1313e. doi: 10.1097/PRS.0000000000009738. Epub 2022 Sep 20.
- Castillo T, Luisa PPM, Clark P, Robertson JP, Montalva FM, Figueroa AA, Mejia ML, Moreno AS, Martinez MD, Aguilera A, Arreguin JC, Dosal MRP, de la Paz Aguilar Saavedra M, Granados A. Developing a core outcome set for anthropometric evaluation for presurgical infant orthopaedics for unilateral cleft lip and palate: e-Delphi consensus. J Plast Reconstr Aesthet Surg. 2022 Oct;75(10):3795-3803. doi: 10.1016/j.bjps.2022.06.065. Epub 2022 Jun 24.
- Yu Q, Gong X, Shen G. CAD presurgical nasoalveolar molding effects on the maxillary morphology in infants with UCLP. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Oct;116(4):418-26. doi: 10.1016/j.oooo.2013.06.032.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Innovinity Medical Hub
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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