Class II Division 1 MalocclusionNCT05171738
Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations
A study testing skeletally anchored distal jet in people with Class II Division 1 Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- skeletally anchored distal jet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Nov 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients should satisfy the following criteria:-
- Age range from 13-17 years.
- Bilateral Class II molar relationship.
- Skeletal Class I or mild Class II relationship.
- Normodivergent skeletal pattern
- No posterior crowding or diastemas.
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- Fully erupted maxillary first and second molars.
- Congenitally missing or extracted third molars.
- Good oral and general health.
- No systemic disease/medication that could interfere with OTM.
- No previous orthodontic treatment.
Who cannot join
- Patient diagnosed to have an indication for non-extraction approach.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
- Previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appraisal of Two Different Approaches of Micro-osteoperforations During Maxillary Molar Distalization Via Skeletally-anchored Distaljet Appliance
study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization.
Read the detailed description
Maxillary molar distalization via skeletally anchored distal jet appliance randomly divided into two equal groups
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- skeletally anchored distal jet
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skeletally anchored distal jetDevice
used from day one and activated every month
| Study group | Role | What they receive |
|---|---|---|
| group(1) | Active comparator | Group I: will include ten patients undergo maxillary molar distalization using skeletally anchored distal jet appliance with MOPs that will be performed buccally on repeated basis on two sides before and during maxillary molar distalization Receives: Device: skeletally anchored distal jet |
| group(2) | Active comparator | Group II:will include ten patients undergo maxillary molar distalization using skeletally anchored distal jet appliance with MOPs that will be performed both buccally and palatally on repeated basis on two sides before and during maxillary molar distalization. Receives: Device: skeletally anchored distal jet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in molar postion
using cephalometric x_ray for measurment
Measured: from start of treatment until study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Sep 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled abd el khaliq hendy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171738
- Sponsor's protocol ID
- 788/309
- Status last verified
- Apr 2022
- First submitted
- 29 Nov 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appraisal of Two Different Approaches of Micro-osteoperforations During Maxillary Molar Distalization Via Skeletally-anchored Distaljet Appliance
- ClinicalTrials.gov ID
- NCT05171738
- Acronym / sponsor ID
- 788/309
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 29 Dec 2021 (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.
study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization.
Detailed description
Maxillary molar distalization via skeletally anchored distal jet appliance randomly divided into two equal groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group(1) | Active comparator | Device: skeletally anchored distal jetGroup I: will include ten patients undergo maxillary molar distalization using skeletally anchored distal jet appliance with MOPs that will be performed buccally on repeated basis on two sides before and during maxillary molar distalization |
| group(2) | Active comparator | Device: skeletally anchored distal jetGroup II:will include ten patients undergo maxillary molar distalization using skeletally anchored distal jet appliance with MOPs that will be performed both buccally and palatally on repeated basis on two sides before and during maxillary molar distalization. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- All patients should satisfy the following criteria:-
- Age range from 13-17 years.
- Bilateral Class II molar relationship.
- Skeletal Class I or mild Class II relationship.
- Normodivergent skeletal pattern
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| skeletally anchored distal jetused from day one and activated every month | Device | group(1), group(2) |
Primary outcome
change in molar postion
Time frame: from start of treatment until study completion, an average of 1 year
using cephalometric x_ray for measurment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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 skeletally anchored distal jet in people with Class II Division 1 Malocclusion, 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 11 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. 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?
change in molar postion (time frame: from start of treatment until study completion, an average of 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 25 Apr 2022.