NCT06015386

Brief Summary

the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 22, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 23, 2023

Last Update Submit

August 28, 2023

Conditions

Anterior Crossbite

Keywords

clear aligner , anterior crossbite , inclined plane

Outcome Measures

Primary Outcomes (1)

  • (OHRQoL (Oral Health-related Quality of Life)

    CPQ8-10 scores at two different points in time.

    4 month

Secondary Outcomes (2)

  • cephalometric analysis of data

    4 month

  • 3D model measurements

    4 month

Study Arms (2)

inclined plane

EXPERIMENTAL

group treated with inclined plane

Other: inclined plane

clear aligner

EXPERIMENTAL

group treated with clear aligner

Other: clear aligner

Interventions

inclined planeOTHER

2 parallel groups one treated with clear aligner and other treated using inclined plane

inclined plane
clear alignerOTHER

2 parallel groups one treated with clear aligner and other treated using inclined plane

clear aligner

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Systemic conditions that may interfere with the treatment.
  • Bad habits that might jeopardize the appliance.
  • Transverse discrepancy.
  • Previous orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Al Mansurah, 35511, Egypt

RECRUITING

Related Publications (1)

  • Salem AS, Albelasy NF, El-Bialy AA. Effectiveness of clear aligner versus removable inclined plane in treatment of anterior crossbite in mixed dentition: A randomized clinical trial. J World Fed Orthod. 2025 Jun;14(3):125-130. doi: 10.1016/j.ejwf.2024.11.001. Epub 2024 Dec 19.

    PMID: 39706691DERIVED

MeSH Terms

Interventions

Orthodontic Appliances, Removable

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Central Study Contacts

asmaa Mohammed, BDS

CONTACT

1142820091asmaasalah@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 29, 2023

Study Start

June 22, 2023

Primary Completion

May 30, 2024

Study Completion

July 30, 2024

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)