NCT06851624

Brief Summary

six months follow-up of two and four mini-screw supported hyrax for maxillary expansion in non-growing patients: A randomized controlled clinical trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

Study Start

First participant enrolled

February 2, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

February 12, 2025

Last Update Submit

February 27, 2025

Conditions

Transverse Maxillary Deficiency

Keywords

expansion,posterior crossbite

Outcome Measures

Primary Outcomes (1)

  • Skeletal effects

    To compare the amount of skeletal expansion using linear (mm) measurement extracted from cone beam computed tomography pre and post-expansion

    6-8 months

Secondary Outcomes (2)

  • Dento-alveolar effects

    6-8 months

  • Dento-alveolar effects

    6-8 months

Study Arms (2)

Group one

EXPERIMENTAL

two mini screws supported hyrax was used

Device: MARPE

Group two

EXPERIMENTAL

four minis crews supported hyrax was used

Device: MARPE

Interventions

MARPEDEVICE

treating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax

Group oneGroup two

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults male or female aged from 18-30 years with skeletal Maxillary constriction.
  • unilateral or bilateral Dental posterior cross-bite.
  • mid-palatal suture maturation (Grade C, D) according to F Angileri classification.
  • good oral hygiene,

You may not qualify if:

  • no functional crossbite due to premature contacts.
  • no previous orthodontic treatment.
  • no buccal crossbite.
  • no craniofacial anomalies or syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11,ElSaraya street ,Almanyal ,CAIRO ,EGYPT

Cairo, Egypt

Location

Study Officials

  • fady hussein fahim, PhD

    Associate proff

    STUDY DIRECTOR

  • nada omar elzawahry, PhD

    lecturer

    STUDY DIRECTOR

  • elzubair osman salih, MSc

    MSc candidates

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two experimental groups ,two screw supported and four screw supported hyrax
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc candidate, Cairo university, department of Orthodontics

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 28, 2025

Study Start

February 2, 2023

Primary Completion

December 5, 2024

Study Completion

January 5, 2025

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)