Class II Division 1 MalocclusionNCT03839303
Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients
A study testing Infra-zygomatic Mini Implant Supported Appliance and high pull head gear in people with Class II Division 1 Malocclusion, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess) Read more about this study
- Who is it for?
- Ages 7 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Infra-zygomatic Mini Implant Supported Appliance and high pull head gear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Dec 2019
- 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 7 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Growing patients ( cervical vertebrae maturation stage cs2-cs3 )
- Maxillary excess
- Minimum overjet 4 mm
- class II canines or incisors
- Increased incisal show at rest and on smiling
- Normal and increased vertical growth pattern
- No previous orthodontic treatment
- No congenitally messing teeth except third molars
Who cannot join
- Inadequate incisal show
- Class II with deficient mandible and normal maxilla
- Patients with any syndrome
- Patients with horizontal growth pattern
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Cairo university, 0223642705 ext. 522
About this study
Official title: Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: A Randomized Clinical Trial
The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess)
Read the detailed description
In this randomized trial, 2 groups will be included. The first group will receive an Infra-zygomatic Mini implant supported appliance. In the second group, the patient will receive a removable high pull headgear. the follow-up period will be 8 months or till class I canine or incisors relation is obtained. the assessment will be through a lateral cephalogram
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Infra-zygomatic Mini Implant Supported Appliance, high pull head gear
- 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.
Infra-zygomatic Mini Implant Supported ApplianceDevice
- leveling and alignment of the four maxillary incisors
- infra zygomatic mini-implant will be placed bilaterally
- wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch
- a heavy arch wire engaging the 4 incisors will be attached to the wire frame work
- orthopedic force will be delivered from the mini-implants to the wire frame work
high pull head gearDevice
- acrylic maxillary splint is made with flying tubes
- high pull head gear is adapted to be inserted in the flying tubes
| Study group | Role | What they receive |
|---|---|---|
| Mini Implant Supported Appliance | Experimental | this group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month Receives: Device: Infra-zygomatic Mini Implant Supported Appliance |
| Headgear | Active comparator | this group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month Receives: Device: high pull head gear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteroposterior position changes of upper first molars.
Measurements on the lateral cephalogram
Measured: 8 months
Anteroposterior position changes of the maxilla
Measurements on the lateral cephalogram
Measured: 8 months
Secondary outcomes (4)
Vertical position changes in maxilla
Measurements on the lateral cephalogram
Measured: 8 months
Vertical position changes of upper first molars
Measurements on the lateral cephalogram
Measured: 8 months
Position changes of upper incisors
Measurements on the lateral cephalogram
Measured: 8 months
Anteroposterior skeletal changes in mandible
Measurements on the lateral cephalogram
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (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 Cairo 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khaled Mohamed Mohamed, Cairo University
- Investigators
- Ahmed Afifi, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839303
- Sponsor's protocol ID
- 18-11-1
- Status last verified
- May 2019
- First submitted
- 11 Feb 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03839303
- Acronym / sponsor ID
- 18-11-1
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 15 Feb 2019 (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 aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess)
Detailed description
In this randomized trial, 2 groups will be included. The first group will receive an Infra-zygomatic Mini implant supported appliance. In the second group, the patient will receive a removable high pull headgear. the follow-up period will be 8 months or till class I canine or incisors relation is obtained. the assessment will be through a lateral cephalogram
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Implant Supported Appliance | Experimental | Device: Infra-zygomatic Mini Implant Supported Appliancethis group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month |
| Headgear | Active comparator | Device: high pull head gearthis group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Growing patients ( cervical vertebrae maturation stage cs2-cs3 )
- Maxillary excess
- Minimum overjet 4 mm
- class II canines or incisors
- Increased incisal show at rest and on smiling
Key exclusion criteria (4 listed)
- Inadequate incisal show
- Class II with deficient mandible and normal maxilla
- Patients with any syndrome
- Patients with horizontal growth pattern
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 |
|---|---|---|
| Infra-zygomatic Mini Implant Supported Appliance1. leveling and alignment of the four maxillary incisors 2. infra zygomatic mini-implant will be placed bilaterally 3. wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch 4. a heavy arch wire engaging the 4 incisors will be attached to the wire frame work 5. orthopedic force will be delivered from the mini-implants to the wire frame work | Device | Mini Implant Supported Appliance |
| high pull head gear1. acrylic maxillary splint is made with flying tubes 2. high pull head gear is adapted to be inserted in the flying tubes | Device | Headgear |
Primary outcome
Anteroposterior position changes of upper first molars.
Time frame: 8 months
Measurements on the lateral cephalogram
Anteroposterior position changes of the maxilla
Time frame: 8 months
Measurements on the lateral cephalogram
4 secondary outcomes
Vertical position changes in maxilla
Time frame: 8 months
Vertical position changes of upper first molars
Time frame: 8 months
Position changes of upper incisors
Time frame: 8 months
Anteroposterior skeletal changes in mandible
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Class II Division 1 Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
CLASS II DIVISION 1 MALOCCLUSION
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LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Recruiting
EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
CLASS II DIVISION 1 MALOCCLUSION
Not yet recruiting
Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
Class II Malocclusion, Class II Malocclusion, Division 1
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.
Ahmed Afifi principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infra-zygomatic Mini Implant Supported Appliance and high pull head gear in people with Class II Division 1 Malocclusion, run by Cairo 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 8 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 21 May 2019. 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?
Contact Ahmed Afifi (+201007025732, Ahmed.Khaled@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anteroposterior position changes of upper first molars. (time frame: 8 months). The study lists 2 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 21 May 2019.