Orthodontic Appliance Complication, Angle Class II Patients, DistalizationNCT05245929
En Masse Distaliaztion Via Skeletal Anchorage
A study testing Distalization in people with Orthodontic Appliance Complication, Angle Class II Patients, Distalization, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication, Angle Class II Patients, Distalization
- What is being tested?
- Distalization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to Jan 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full set of permanent teeth present, except for third molar
- Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
- No systemic conditions interfering with treatment, as reported by patient
- No previous Orthodontic treatment
- Good Oral Hygiene
- No use of any for of anti-inflammatory drugs
Who cannot join
- Patient who required surgery to correct skeletal discrepancies
- Patient with congenital dentoskeletal disorders
- Missed or Mutilated teeth in Maxillary arch
- Patients with poor oral hygiene
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University, faculty of dental medicine orthodontic clinic
Cairo, Nasr City
Ramadan Abu Shahba, Professor, 01012624339, ramadan.abushahba@su.edu.eg
About this study
Official title: Evaluation of Two Bone Anchored Appliances for en Masse Distalization of Maxillary Buccal Segment in Class II Patients: A Comparative Clinical Study
Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.
- Being tested
- Distalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistalizationDevice
Distalizing the posterior maxillary segment
| Study group | Role | What they receive |
|---|---|---|
| Skeletally anchored Distal Jet appliance | Active comparator | Not described Receives: Device: Distalization |
| Skeletally anchored Hyrax screw distalizer | Active comparator | Not described Receives: Device: Distalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of distalization
difference in initial and final position of maxillary posterior segment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start5 Jan 2021
- Primary completionMay 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance Complication, Angle Class II Patients, DistalizationStudies 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
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kadry Ahmed Algariah, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245929
- Sponsor's protocol ID
- Dist007
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 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 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Bone Anchored Appliances for en Masse Distalization of Maxillary Buccal Segment in Class II Patients: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT05245929
- Acronym / sponsor ID
- Dist007
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Feb 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.
Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skeletally anchored Distal Jet appliance | Active comparator | Device: Distalization |
| Skeletally anchored Hyrax screw distalizer | Active comparator | Device: Distalization |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Full set of permanent teeth present, except for third molar
- Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
- No systemic conditions interfering with treatment, as reported by patient
- No previous Orthodontic treatment
- Good Oral Hygiene
Key exclusion criteria (4 listed)
- Patient who required surgery to correct skeletal discrepancies
- Patient with congenital dentoskeletal disorders
- Missed or Mutilated teeth in Maxillary arch
- Patients with poor oral hygiene
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 |
|---|---|---|
| DistalizationDistalizing the posterior maxillary segment | Device | Skeletally anchored Distal Jet appliance, Skeletally anchored Hyrax screw distalizer |
Primary outcome
Amount of distalization
Time frame: 6 months
difference in initial and final position of maxillary posterior segment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Undecided
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.
Al-Azhar University, faculty of dental medicine orthodontic clinic
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distalization in people with Orthodontic Appliance Complication, Angle Class II Patients, Distalization, 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 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 18 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of distalization (time frame: 6 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 18 Feb 2022.