Anterior Open Bite in Mixed DentitionNCT07379632
Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction
A study testing Zachrisson transpalatal arch and Vertical holding appliance in people with Anterior Open Bite in Mixed Dentition, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Open Bite in Mixed Dentition
- What is being tested?
- Zachrisson transpalatal arch and Vertical holding appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Systemic disease.
- Missing teeth.
- Previous orthodontic treatment.
- Presence of posterior crossbites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction During Mixed Dentition: A Randomized Controlled Trial
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.
- Conditions
- Anterior Open Bite in Mixed Dentition
- Being tested
- Zachrisson transpalatal arch, Vertical holding appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zachrisson transpalatal archDevice
transpalatal arch with 2 posterior loops and 1 anterior loop
Vertical holding applianceDevice
transpalatal arch with arcylic button
| Study group | Role | What they receive |
|---|---|---|
| vertical holding appliance | Active comparator | a transpalatal arch with acrylic button Receives: Device: Vertical holding appliance |
| Zachrisson transpalatal arch | Experimental | a transpalatal arch with 2 posterior loops and 1 anterior loop Receives: Device: Zachrisson transpalatal arch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical skeletal measurements using cephalometric analysis
Measured: 9 months
Secondary outcomes (1)
Overbite reduction
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Open Bite in Mixed DentitionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Alaa Yehia, Cairo University
- Investigators
- ola a yehia, master student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379632
- Sponsor's protocol ID
- 3-3-4
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction During Mixed Dentition: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07379632
- Acronym / sponsor ID
- 3-3-4
- Conditions
- Anterior Open Bite in Mixed Dentition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertical holding appliance | Active comparator | Device: Vertical holding appliancea transpalatal arch with acrylic button |
| Zachrisson transpalatal arch | Experimental | Device: Zachrisson transpalatal archa transpalatal arch with 2 posterior loops and 1 anterior loop |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Systemic disease.
- Missing teeth.
- Previous orthodontic treatment.
- Presence of posterior crossbites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zachrisson transpalatal archtranspalatal arch with 2 posterior loops and 1 anterior loop | Device | Zachrisson transpalatal arch |
| Vertical holding appliancetranspalatal arch with arcylic button | Device | vertical holding appliance |
Primary outcome
Vertical skeletal measurements using cephalometric analysis
Time frame: 9 months
1 secondary outcome
Overbite reduction
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ola a yehia, master student principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zachrisson transpalatal arch and Vertical holding appliance in people with Anterior Open Bite in Mixed Dentition, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ola a yehia, master (01015618886, ola.alaa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical skeletal measurements using cephalometric analysis (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.