NCT04970095

Brief Summary

Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC 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
1 day until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
12 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

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 16, 2021

Last Update Submit

July 20, 2021

Conditions

Cleft Lip and Palate

Keywords

Alt-RAMECexpansioncleft lip and palate patientcone beam computed tomography (CBCT)protractionfacemaskMAXILLARY EXPANDER WITH DIFFERENTIAL OPENING (EDO)

Outcome Measures

Primary Outcomes (1)

  • change in 3D dimension of skull after and before expansion

    Full skull Cone Beam Computerized Tomography

    six month

Study Arms (1)

cleft lip and palate patient

EXPERIMENTAL

Clefts patient 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 patient
Petit Face MaskDEVICE

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

cleft lip and palate patient

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.
  • \. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .
  • \. Absent maxillary permanent first molars. 4. 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)

  • Garib D, Lauris RC, Calil LR, Alves AC, Janson G, De Almeida AM, Cevidanes LH, Lauris JR. Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):564-574. doi: 10.1016/j.ajodo.2016.05.006.

    PMID: 27692413BACKGROUND

  • Singh S, Batra P, Raghavan S, Sharma K, Srivastava A. Evaluation of Alt-RAMEC With Facemask in Patients With Unilateral Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT) and Finite Element Modeling-A Clinical Prospective Study. Cleft Palate Craniofac J. 2022 Feb;59(2):166-176. doi: 10.1177/10556656211000968. Epub 2021 Mar 23.

    PMID: 33754882BACKGROUND

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

  • maha m. mohamed, phd

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

    STUDY DIRECTOR

Central Study Contacts

sarah s. kahlil, master

CONTACT

+201128899261sarahabdelaal.p5821@azhar.edu.eg

mohamed m. elabd, master

CONTACT

+201064244061sarahlala83@gmail.com

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

July 16, 2021

First Posted

July 21, 2021

Study Start

July 15, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Evaluation of EDO ,Alt-RAMEC With Facemask in Patients With Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

Locations

EG(1)