Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches

NCT05940389 | Unknown DMC

• 1 other identifier: Innovinity Medical Hub
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The nasal deformity is an abnormality in the appearance and structure of the nose in cleft patients having unilateral cleft lip and palate (UCLP). It involves the displacement of the lower lateral nasal cartilage, oblique and short columella, depressed dome, overhanging nostril apex, and deviated septum. Difficulty in breathing and smelling are the main problems of this deformity. Rhinoplasty for CLP patients is very complicated due to the complex nature of this type of deformity, especially in wide and bilateral cleft patients it is quite challenging.

Conditions

Unilateral Cleft Lip; Nasoalveolar Molding

Keywords

NAM; UCLP; pre-surgical orthopedics; DynaCleft

Outcome Measures

Primary Outcomes (9)

• Change in nasal tip projection

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (9)

• Change in the alveolar cleft width

  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

  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

  T0= before Intervention, T1= after 1 month, T2= after 6 months, T3=after 1 year

• Change in lesser segment perimeter

  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

  T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery

Study Arms (2)

NAM appliance Group

EXPERIMENTAL

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.

Device: Naso Alveolar Mold

Taping with nasal elevator:

EXPERIMENTAL

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.

Device: Taping with nasal elevator:

Interventions

Naso Alveolar Mold DEVICE

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.

Also known as: NAM

NAM appliance Group

Taping with nasal elevator: DEVICE

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.

Also known as: DYNA

Taping with nasal elevator:

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Syndromic UCLP or bilateral cleft lip and palate
• Incomplete UCLP
• Cleft width ≤ 5 mm

Sponsors & Collaborators

• Al-Azhar University: lead
• Innovinity medical hub: collaborator
• Smile train: collaborator

Related Publications (11)

• 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.

  PMID: 33882703 BACKGROUND

• 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.

  PMID: 36410660 BACKGROUND

• 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.

  PMID: 31860800 BACKGROUND

• 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.

  PMID: 32909815 BACKGROUND

• 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.

  PMID: 24732649 BACKGROUND

• 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.

  PMID: 32772701 BACKGROUND

• 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.

  PMID: 36126199 BACKGROUND

• 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.

  PMID: 10574667 BACKGROUND

• 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.

  PMID: 36075806 BACKGROUND

• 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.

  PMID: 24035109 BACKGROUND

• 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.

  PMID: 17695343 BACKGROUND

Central Study Contacts

Abdallah Bahaa, M.Sc.

CONTACT

01114084090; abdallahbahaa000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be single-blinded. The outcome assessors will be blinded as the measurements will be done on laser-scanned casts and 3D facial images. The operator and the patient's parent cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: A randomized clinical trial, parallel arm, superiority framework with 1:1 allocation ratio.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 11, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE