Dental IntrusionNCT05433051
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
A study testing buccal miniscrew and TPA and vertical holding appliance in people with Dental Intrusion and Mandibular Rotation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Dental Intrusion, Mandibular Rotation, ANB , SNA, SNB
- What is being tested?
- buccal miniscrew and TPA and vertical holding appliance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to 30 Oct 2024
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients suffering class I or II with AOB.
- AOB ranged between 3-7 mm assessed from cephalometry.
- Patients with excess in posterior dentoalveolar height according to Burrstone .
- Patients with good oral hygiene and general health.
- Patients with no previous orthodontic treatment.
- Good quality of lateral cephalometry.
Who cannot join
- Skeletal open bite
- previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial
this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.
- Conditions
- Dental Intrusion, Mandibular Rotation, ANB , SNA, SNB, Openbite Teeth | Teeth and Gum | Dental
- Being tested
- buccal miniscrew and TPA, vertical holding appliance
- Keywords
- TPA, Miniscrew, intrusion, vertical holding appliance, cephalometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal miniscrew and TPABiological
intrusion of molars
vertical holding applianceBiological
intrusion of molars
| Study group | Role | What they receive |
|---|---|---|
| Buccal miniscrews with TPA | Active comparator | active comparator double center Receives: Biological: buccal miniscrew and TPA |
| vertical holding appliance | Active comparator | active comparator double center Receives: Biological: vertical holding appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of dental
rate of maxillary molar intrusion by cephalometry
Measured: Post-intervention at 6 months
amount of skeletal changes
amount of vertical overlap by cephalometry
Measured: Post-intervention at 6 months
amount of skeletal changes
amount of mandibular rotation by cephalometry
Measured: Post-intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start10 Apr 2022
- Primary completion10 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental IntrusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelrhman Shendy Abdelrhman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433051
- Sponsor's protocol ID
- 807/220
- Status last verified
- May 2024
- First submitted
- 22 Jun 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05433051
- Acronym / sponsor ID
- 807/220
- Conditions
- Dental Intrusion, Mandibular Rotation, ANB , SNA, SNB, Openbite Teeth | Teeth and Gum | Dental
- Keywords
- TPA, Miniscrew, intrusion, vertical holding appliance, cephalometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 27 Jun 2022 (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.
this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal miniscrews with TPA | Active comparator | Biological: buccal miniscrew and TPAactive comparator double center |
| vertical holding appliance | Active comparator | Biological: vertical holding applianceactive comparator double center |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients suffering class I or II with AOB.
- AOB ranged between 3-7 mm assessed from cephalometry.
- Patients with excess in posterior dentoalveolar height according to Burrstone .
- Patients with good oral hygiene and general health.
- Patients with no previous orthodontic treatment.
Key exclusion criteria (2 listed)
- Skeletal open bite
- previous orthodontic treatment
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 |
|---|---|---|
| buccal miniscrew and TPAintrusion of molars | Biological | Buccal miniscrews with TPA |
| vertical holding applianceintrusion of molars | Biological | vertical holding appliance |
Primary outcome
amount of dental
Time frame: Post-intervention at 6 months
rate of maxillary molar intrusion by cephalometry
amount of skeletal changes
Time frame: Post-intervention at 6 months
amount of vertical overlap by cephalometry
amount of skeletal changes
Time frame: Post-intervention at 6 months
amount of mandibular rotation by cephalometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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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 buccal miniscrew and TPA and vertical holding appliance in people with Dental Intrusion and Mandibular Rotation, run by Al-Azhar 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 2 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 22 May 2024. 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?
amount of dental (time frame: Post-intervention at 6 months). The study lists 3 primary outcomes in all. 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 22 May 2024.