Distalization by MiniscrewsPhase 1AUNCT02427282
Distalization by Miniscrew
A Phase 1 study testing miniscrew-supported Frog molar distalizing appliance and Standard Frog molar distalizing appliance in people with Distalization by Miniscrews, run by Ain Shams University.
Trial summary
This study aimed to compare the effectiveness and efficiency of miniscrew-supported and standard frog molar distalizing appliances. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Distalization by Miniscrews
- What is being tested?
- miniscrew-supported Frog molar distalizing appliance and Standard Frog molar distalizing appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Mar 2015
- Phase
- Phase 1
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
- All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
- All the subjects had bilateral Class II molar relationship.
- All subjects were free from any dental anomalies.
- All subjects had good oral hygiene.
Who cannot join
- Missing permanent teeth with exception of 3rd molar.
- Previous orthodontic treatment.
- Systemic disease that may influence orthodontic treatment and drug intake.
- Periodontal disease.
- Functional mandibular deviations and facial asymmetry.
- History of parafunctional habits.
About this study
Official title: Miniscrew-supported Versus Standard Frog Molar Distalizing Appliances (Clinical Study)
This study aimed to compare the effectiveness and efficiency of miniscrew-supported and standard frog molar distalizing appliances.
Read the detailed description
A prospective randomized clinical trial study was carried out on twenty healthy Egyptian subjects, each required molar distalization as part of their comprehensive orthodontic treatment. The subjects were selected and treated at the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Ain-Shams University.
The inclusion criteria in this subject selection in this study was as follows;
- All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
- All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
- All the subjects had bilateral Class II molar relationship.
- All subjects were free from any dental anomalies.
- All subjects had good oral hygiene. The exclusion criteria in this study was as follows; 1- Missing permanent teeth with exception of 3rd molar. 2- Previous orthodontic treatment. 3- Systemic disease that may influence orthodontic treatment and drug intake. 4- Periodontal disease. 5- Functional mandibular deviations and facial asymmetry. 6- History of parafunctional habits.
The subjects were equally and randomly divided into two groups; group A and group B which included ten subjects per group. These groups were classified according to the type of distalizer utilized:
- Group A: included ten subjects utilizing the conventional frog molar distalizing appliance (CF).
- Group B: included ten subjects utilizing the Miniscrews-supported frog molar distalizing appliance (MSF)
The pretreatment and post-distalization Database Records All subjects had the following records; a clinical diagnostic sheet, orthodontic study cast (according to ABO index), extraoral and intraoral photographs, and CBCT.
These records were obtained at T1 before distalization and at T2 after distalization.
The study protocol was approved by the local ethics committee, faculty of dentistry, Ain-Shams University. Before commencing with treatment, all the subjects and their guardians received a full explanation of the treatment protocol. After which they were asked to sign a detailed written consent.
- Conditions
- Distalization by Miniscrews
- Being tested
- miniscrew-supported Frog molar distalizing appliance, Standard Frog molar distalizing appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniscrew-supported Frog molar distalizing applianceDevice
Also called Skeletal Frog
miniscrew 10mm length and 1.7mm diameter FORESTADENT company
Standard Frog molar distalizing applianceDevice
Also called Conventional Frog
Nance buttons attached to first premolars band
| Study group | Role | What they receive |
|---|---|---|
| MS. Frog | Active comparator | miniscrew-supported frog molar distalizing appliance Receives: Device: miniscrew-supported Frog molar distalizing appliance |
| Stand. Frog | Experimental | Standard Frog appliance Receives: Device: Standard Frog molar distalizing appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography
pretreatment and postdistalization records as cone beam computerized tomography and cast analysis
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distalization by MiniscrewsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riyadh Abdullah Iskander, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427282
- Sponsor's protocol ID
- 999
- Acronym
- AU
- Status last verified
- Apr 2015
- First submitted
- 19 Apr 2015
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miniscrew-supported Versus Standard Frog Molar Distalizing Appliances (Clinical Study)
- ClinicalTrials.gov ID
- NCT02427282
- Acronym / sponsor ID
- AU / 999
- Conditions
- Distalization by Miniscrews
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Apr 2015 (estimated)
- 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 aimed to compare the effectiveness and efficiency of miniscrew-supported and standard frog molar distalizing appliances.
Detailed description
A prospective randomized clinical trial study was carried out on twenty healthy Egyptian subjects, each required molar distalization as part of their comprehensive orthodontic treatment. The subjects were selected and treated at the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Ain-Shams University.
The inclusion criteria in this subject selection in this study was as follows;
- All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
- All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
- All the subjects had bilateral Class II molar relationship.
- All subjects were free from any dental anomalies.
- All subjects had good oral hygiene. The exclusion criteria in this study was as follows; 1- Missing permanent teeth with exception of 3rd molar. 2- Previous orthodontic treatment. 3- Systemic disease that may influence orthodontic treatment and drug intake. 4- Periodontal disease. 5- Functional mandibular deviations and facial asymmetry. 6- History of parafunctional habits.
The subjects were equally and randomly divided into two groups; group A and group B which included ten subjects per group. These groups were classified according to the type of distalizer utilized:
- Group A: included ten subjects utilizing the conventional frog molar distalizing appliance (CF).
- Group B: included ten subjects utilizing the Miniscrews-supported frog molar distalizing appliance (MSF)
The pretreatment and post-distalization Database Records All subjects had the following records; a clinical diagnostic sheet, orthodontic study cast (according to ABO index), extraoral and intraoral photographs, and CBCT.
These records were obtained at T1 before distalization and at T2 after distalization.
The study protocol was approved by the local ethics committee, faculty of dentistry, Ain-Shams University. Before commencing with treatment, all the subjects and their guardians received a full explanation of the treatment protocol. After which they were asked to sign a detailed written consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS. Frog | Active comparator | Device: miniscrew-supported Frog molar distalizing applianceminiscrew-supported frog molar distalizing appliance |
| Stand. Frog | Experimental | Device: Standard Frog molar distalizing applianceStandard Frog appliance |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
- All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
- All the subjects had bilateral Class II molar relationship.
- All subjects were free from any dental anomalies.
- All subjects had good oral hygiene.
Key exclusion criteria (6 listed)
- Missing permanent teeth with exception of 3rd molar.
- Previous orthodontic treatment.
- Systemic disease that may influence orthodontic treatment and drug intake.
- Periodontal disease.
- Functional mandibular deviations and facial asymmetry.
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 |
|---|---|---|
| miniscrew-supported Frog molar distalizing applianceAlso: Skeletal Frogminiscrew 10mm length and 1.7mm diameter FORESTADENT company | Device | MS. Frog |
| Standard Frog molar distalizing applianceAlso: Conventional FrogNance buttons attached to first premolars band | Device | Stand. Frog |
Primary outcome
mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography
Time frame: 6months
pretreatment and postdistalization records as cone beam computerized tomography and cast analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
Related trials for Distalization by Miniscrews
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"Sliding Jigs vs Retraction Hooks for Maxillary Dentition Distalization Using IZC Miniscrews"
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Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer
Tooth Movement Techniques, Distalization by Miniscrews
Recruiting
Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.
Distalization, Class II Malocclusion
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing miniscrew-supported Frog molar distalizing appliance and Standard Frog molar distalizing appliance in people with Distalization by Miniscrews, run by Ain Shams University.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography (time frame: 6months). 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 4 May 2015.