Nasoalveolar Molding for Egyptian Cleft Lip Palate Infants

NCT03029195 | Completed

• 1 other identifier: AlexandriaU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The cleft lip and palate (CLP) is the commonest craniofacial anomaly worldwide. Nasoalveolar molding (NAM) therapy has emerged in the management of CLP as an early presurgical intervention to provide symmetry to severely deformed nasal cartilage, achieve projection to the flattened nasal tip, provide nonsurgical elevation for the columella, improve alignment of the alveolar ridge, reduce the cleft gap and it could significantly reduce the number of secondary surgeries. Despite that NAM therapy is becoming the treatment option for early cleft care, there is growing debate about its efficacy due to lack of quantitative assessment of these findings. To provide the highest levels of clinical evidence on NAM therapy, there has been international call for Randomized Controlled Clinical Trials. Statement of the problem: lack of quantitative data about the efficacy of the NAM therapy for unilateral CLP. Aim of the study: is to develop a standardized non-invasive quantitative assessment for two different techniques of the NAM therapy in Egyptian infants that involves 3D laser scanning/CAD analysis for maxillary geometry, and nasal anthropometric analysis. Methods Trial design: Prospective randomized controlled clinical trial (RCT). Settings: The RCT will be performed through two phases; (Phase I: A controlled pre and post-RCT that will be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry), and (Phase II: A post-test RCT will be designed for the quantitative evaluation of the NAM therapy on the nasal anthropometry and comparing the outcome with the nasal anthropometry that will be performed to age matched Egyptian norms). Participants: 30 Egyptian infants with nonsyndromic UCLP will be randomly allocated to study groups (Group I, n=15) that will undergo NAM therapy before the primary surgical repair, and control group (n=15) that will undergo the primary surgical repair without NAM therapy. And 15 Egyptian infants will act as norm group. Follow-up: (phase I- T0: before NAM, T1: after 1 month and T2: before surgery). (Phase II- T"0: 10 days after surgery, and T"1: 6 months after surgery).

Conditions

Cleft Lip Palate; Cleft Lip, Unilateral, Complete

Keywords

cleft lip and palate; nasoalveolar molding; Egyptian infants; quantitative analysis

Outcome Measures

Primary Outcomes (1)

• Three dimensional (3D) change in the maxillary geometry.

  CAD analysis for the maxillary casts that will be obtained from the cleft infants in both study and control group.

  (T0 baseline; pre-NAM therapy), (T2 during NAM therapy) and (T3 before surgery)

Secondary Outcomes (1)

• Change in the nasal anthropometry.

  ( T"0 = 1 days post-surgery) and (T"1= 6 months post-surgery).

Other Outcomes (1)

• Nasal anthropometry of age-matched (6 months old) Egyptian norms.

  ( T"0 = 10 days post-surgery) and (T"1= 6 months post-surgery).

Study Arms (3)

Study group

EXPERIMENTAL

Nasoalveolar molding therapy for cleft lip and palate infants

Device: Nasoalveolar molding therapy

Control group

NO INTERVENTION

No nasoalveolar molding therapy for cleft lip and palate infants

Age matched Norms

NO INTERVENTION

Normal (non-cleft) age matched infants

Interventions

Nasoalveolar molding therapy DEVICE

Presurgical infant orthopedics

Study group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Egyptian infants.
• Infants should present with nonsyndromic complete UCLP ,
• Infant age should be less than 90 days.
• The infant's family agreed to undergo NAM therapy.

You may not qualify if:

• Congenital malformations and soft tissue bands.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (7)

• 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

• Braumann B, Keilig L, Bourauel C, Jager A. Three-dimensional analysis of morphological changes in the maxilla of patients with cleft lip and palate. Cleft Palate Craniofac J. 2002 Jan;39(1):1-11. doi: 10.1597/1545-1569_2002_039_0001_tdaomc_2.0.co_2.

  PMID: 11772163 BACKGROUND

• Clark JM, Skoner JM, Wang TD. Repair of the unilateral cleft lip/nose deformity. Facial Plast Surg. 2003 Feb;19(1):29-40. doi: 10.1055/s-2003-39134.

  PMID: 12739180 BACKGROUND

• Meara JG, Andrews BT, Ridgway EB, Raisolsadat MA, Hiradfar M. Unilateral cleft lip and nasal repair: techniques and principles. Iran J Pediatr. 2011 Jun;21(2):129-38.

  PMID: 23056779 BACKGROUND

• Sommerlad BC. International confederation for cleft lip and palate and related craniofacial anomalies task force report: palatoplasty in the speaking individual with unrepaired cleft palate. Cleft Palate Craniofac J. 2014 Nov;51(6):e122-8. doi: 10.1597/14-124. Epub 2014 Jul 9.

  PMID: 25007031 BACKGROUND

• Singh GD, Levy-Bercowski D, Santiago PE. Three-dimensional nasal changes following nasoalveolar molding in patients with unilateral cleft lip and palate: geometric morphometrics. Cleft Palate Craniofac J. 2005 Jul;42(4):403-9. doi: 10.1597/04-063.1.

  PMID: 16001922 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 DERIVED

MeSH Terms

Conditions

Cleft Lip

Interventions

Nasoalveolar Molding

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Preoperative Care; Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mona S. Saad, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Prosthodontics

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 24, 2017
• Study Start: March 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)