NCT04331379

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

March 30, 2020

Last Update Submit

March 9, 2022

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (2)

  • Nasal Esthetics

    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.

    3 months

  • Maxillary arch changes

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

    3 months

Study Arms (2)

Nasal Elevator

EXPERIMENTAL
Device: Nasal Elevator

Taping Alone

ACTIVE COMPARATOR
Device: Taping Alone

Interventions

Nasal ElevatorDEVICE

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

Nasal Elevator
Taping AloneDEVICE

Horizontal tape alone.

Taping Alone

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Giza, 00202, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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 Orthodontics

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

July 9, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

EG(1)