NCT07379632

Brief Summary

The aim of the study is to assess the treatment effects of ZTPA versus VHA in the correction of anterior open bite in mixed dentition.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Anterior Open Bite in Mixed Dentition

Outcome Measures

Primary Outcomes (1)

  • Vertical skeletal measurements using cephalometric analysis

    9 months

Secondary Outcomes (1)

  • Overbite reduction

    9 months

Study Arms (2)

vertical holding appliance

ACTIVE COMPARATOR

a transpalatal arch with acrylic button

Device: Vertical holding appliance

Zachrisson transpalatal arch

EXPERIMENTAL

a transpalatal arch with 2 posterior loops and 1 anterior loop

Device: Zachrisson transpalatal arch

Interventions

Vertical holding applianceDEVICE

transpalatal arch with arcylic button

vertical holding appliance
Zachrisson transpalatal archDEVICE

transpalatal arch with 2 posterior loops and 1 anterior loop

Zachrisson transpalatal arch

Eligibility Criteria

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

You may qualify if:

  • Children with the age rage from 6-12 years old.
  • Both male and female.
  • Class I and II skeletal and dental.
  • Skeletal anterior open bite.
  • Maxillary and mandibular incisors and upper first molars erupted.
  • Good oral hygiene.

You may not qualify if:

  • Systemic disease.
  • Missing teeth.
  • Previous orthodontic treatment.
  • Presence of posterior crossbites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

RECRUITING

Study Officials

  • ola a yehia, master student

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ola a yehia, master

CONTACT

01015618886ola.alaa@dentistry.cu.edu.eg

yomna a yehia, master

CONTACT

01001459692yomna.alaa@dentistry.cu.edu.eg

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
Master student

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

EG(1)