NCT05193513

Brief Summary

in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

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
20

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 10, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2023

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

January 3, 2022

Last Update Submit

January 3, 2022

Conditions

Cross Bite

Outcome Measures

Primary Outcomes (1)

  • change in maxillary width

    millimeter

    12 weeks following end of treatment

Study Arms (2)

group (1)

EXPERIMENTAL

tow perpendicular miniscrews supported hybrid expanders

Device: hybrid expanders

group (2)

EXPERIMENTAL

tow angulated miniscrews supported hybrid expanders

Device: hybrid expanders

Interventions

hybrid expandersDEVICE

tow maxillary hybrid expanders supported anteriorly with tow miniscrews

group (1)group (2)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Medically free male or female patients
  • Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
  • The patient should have no missing teeth except third molars.
  • Age ranged from 12 to 18 years old.
  • The patient should have a good gingival condition.
  • The patient should have a good periodontal condition.

You may not qualify if:

  • hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al azhar university

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparison of tow maxillary hybrid expanders -perpendicular screw Supported versus lateral angulated one; a prospective randomized clinical study

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 18, 2022

Study Start

July 10, 2021

Primary Completion

June 10, 2023

Study Completion

October 14, 2023

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

EG(1)