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Completed

NCT Number: NCT04331379

Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate

This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.

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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

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Giza, 00202, Egypt

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 1-30 days.
  • Unilateral complete cleft lip and alveolus.
  • Medically free subjects.
  • Both males and females.
  • Cleft gap more than 10 mm.

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.
  • Patient with previous surgical lip repair or adhesion.
  • Patients with previous presurgical infant orthopedic treatment.
  • Medically compromised patients.
  • Cleft gap distance less than 10mm

Treatment and study plan

Nasal Elevator

Device

A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.

Taping Alone

Device

Horizontal tape alone.

Primary outcomes

  1. Nasal Esthetics

    Time frame: 3 months

    Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software.

  2. Maxillary arch changes

    Time frame: 3 months

    Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Nasal-alar Elevator (NE) Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2020
Registry last updated
Mar 10, 2022

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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