Anterior Openbite MalocclusionNCT06147739
Evaluation Treatment Outcomes of Anterior Open Bite Treated by Temporary Anchorage Devices
A study testing Temporary Anchorage Devices in people with Anterior Openbite Malocclusion, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The present study will be performed to Evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Openbite Malocclusion
- What is being tested?
- Temporary Anchorage Devices
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2021to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients age range 13-18 years old.
- Patients have anterior open bite.
- Normal healthy patient.
- Patient have healthy oral tissues.
- Patient have class I or II jaw relationship.
- Patient have complete set of permanent teeth except the wisdom tooth.
Who cannot join
- Uncooperative patient and parents.
- patient who had undergo previous orthodontic treatment.
- Patient with class III jaw relationship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Treatment Outcomes of Anterior Open Bite Treated With Maxillary Intrusive Force by Temporary Anchorage Devices
The present study will be performed to Evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws
- Conditions
- Anterior Openbite Malocclusion
- Being tested
- Temporary Anchorage Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Anchorage DevicesOther
intrusion
What is being measured
The primary outcome is the main question the study is designed to answer.
open bite closure
the change in amount of open bite detected by mm. which measured from the cast model and from cephalometric x ray.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start11 Aug 2021
- Primary completion11 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Openbite MalocclusionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bayan Saaidi, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147739
- Sponsor's protocol ID
- ORTHO-109-2-G
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Treatment Outcomes of Anterior Open Bite Treated With Maxillary Intrusive Force by Temporary Anchorage Devices
- ClinicalTrials.gov ID
- NCT06147739
- Acronym / sponsor ID
- ORTHO-109-2-G
- Conditions
- Anterior Openbite Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 11 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 28 Nov 2023 (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 present study will be performed to Evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients age range 13-18 years old.
- Patients have anterior open bite.
- Normal healthy patient.
- Patient have healthy oral tissues.
- Patient have class I or II jaw relationship.
Key exclusion criteria (3 listed)
- Uncooperative patient and parents.
- patient who had undergo previous orthodontic treatment.
- Patient with class III jaw relationship.
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 |
|---|---|---|
| Temporary Anchorage Devicesintrusion | Other | – |
Primary outcome
open bite closure
Time frame: 1 year
the change in amount of open bite detected by mm. which measured from the cast model and from cephalometric x ray.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Anterior Openbite Malocclusion
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Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
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Recruiting
Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite
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RecruitingObservational study
Stability of Orthodontic Treatment of Anterior Open-bite
Open Bite
Active, not recruiting
Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial.
Skeletal Open Bite, Open Bite
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Anchorage Devices in people with Anterior Openbite Malocclusion, run by Faculty of Dental Medicine for Girls 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 3 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
open bite closure (time frame: 1 year). 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 28 Nov 2023.