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Completed

NCT Number: NCT02845193

Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

7 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 00202, Egypt

About this study

In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with age range from 7 - 30 days.
  • Unilateral complete cleft lip and alveolus.
  • Presence of unilateral cleft palate.
  • Medically free subjects.
  • Both males and females.

Exclusion criteria

  • Patients older than 30 days.
  • Syndromic patients with other defects in addition to cleft lip and palate.
  • Patients with bilateral cleft lip and palate.
  • Incomplete Cleft lip.
  • Medically compromised patients.

Treatment and study plan

Modified Nasoalveolar molding

Device

Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).

Taping

Device

Infants will receive a tape only on the upper lip segments to mold it to touch each other.

CAD/NAM

Device

computer aided design NAM

Primary outcomes

  1. Parents' satisfaction

    Time frame: 3 months

    It will be assessed using Questionnaire.

Secondary outcomes

  1. Nasal Esthetics: a- Nostril height

    Time frame: 3 months

    It will be measured in mm by Digital ruler on the images using a software.

  2. Nasal Esthetics: b- Nostril width

    Time frame: 3 months

    It will be measured in mm by Digital ruler on the images using a software.

  3. Nasal Esthetics: c- Nasal sill height

    Time frame: 3 months

    It will be measured in mm by Digital ruler on the images using a software.

  4. Nasal Esthetics: d- Nostril area

    Time frame: 3 months

    It will be measured on the images in mm 2 (square) using a software measuring area.

  5. Interlabial gap

    Time frame: 3 months

    It will be measured in mm by Digital ruler on the images using a software.

  6. Maxillary Arch Dimension

    Time frame: 3 months

    It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 27, 2016
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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