NCT04997083

Brief Summary

Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 4, 2021

Last Update Submit

August 4, 2021

Conditions

Cleft Lip and Palate

Keywords

Cleft lip and palateExpansionSlow expansionMaxillary expander with differential opening (EDO)ProtractionFace maskCone beam computed tomography (CBCT)

Outcome Measures

Primary Outcomes (1)

  • Changes in 3 dimensions of skull before and after expansion

    Full skull Cone Beam Computerized Tomography

    Six months

Study Arms (1)

cleft lip and palate patients

EXPERIMENTAL

Cleft patients with transverse maxillary constriction and anteroposterior deficiency

Device: Maxillary Expander with Differential Opening (EDO)Device: Petit face mask

Interventions

Maxillary Expander with Differential Opening (EDO)DEVICE

The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.

cleft lip and palate patients
Petit face maskDEVICE

The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar.

cleft lip and palate patients

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All patient age ranges from 8 to 12 years.
  • Patients of both sexes.
  • Cleft lip and palate patients.
  • All the cases showed maxillary arch constriction and deficiency.
  • All patients had maxillary permanent first molars.
  • Primary lip adhesion and palatal closure.

You may not qualify if:

  • Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before.
  • Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar).
  • Absent maxillary permanent first molars.
  • Uncooperative patients/parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dental medicine for girls, Al-Azhar University

Cairo, Nasr City, 0000, Egypt

RECRUITING

Related Publications (2)

  • Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010.

    PMID: 31901284BACKGROUND

  • Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.

    PMID: 33580351BACKGROUND

Related Links

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amany M. Diab, PhD

    Lecturer of Orthodontics Department, Faculty of Dental Medicine for Girls, Al-Azhar University

    STUDY DIRECTOR

Central Study Contacts

Amira H. Eldawy, Master

CONTACT

+201112788674amiraeldawy.p5821@azhar.edu.eg

Taghreed R. Alazzawi, Master

CONTACT

+201001581382TaghreedAlazzawi.p5821@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 9, 2021

Study Start

July 15, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Evaluation of EDO, Slow maxillary expansion and facemask in patients with cleft lip and palate (CLP) using Cone Beam Computed Tomography (CBCT)

Locations

EG(1)