NCT04331977

Brief Summary

This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

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 2, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

March 30, 2020

Last Update Submit

February 11, 2023

Conditions

Cleft Lip and PalateMaxillary Expansion

Outcome Measures

Primary Outcomes (2)

  • Maxillary Expansion

    Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.

    6 months

  • Maxillary Expansion

    mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.

    6 months

Study Arms (2)

Quadhelix Group

EXPERIMENTAL
Device: Maxillary Expansion

Hyrax Group

ACTIVE COMPARATOR
Device: Maxillary Expansion

Interventions

Maxillary ExpansionDEVICE

2 appliances to expand the maxillary arch

Hyrax GroupQuadhelix Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mixed dentition stage;
  • Both males and females;
  • Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
  • Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
  • Permanent first maxillary molars present;
  • Good periodontal health;
  • No previous orthodontic treatment; and

You may not qualify if:

  • Presence of a syndrome in companion with the present cleft defect.
  • Previous secondary alveolar bone grafting.
  • Taking medications affecting growth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Giza Governorate, 00202, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

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 2, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

EG(1)