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CLASS II DIVISION 1 MALOCCLUSIONPhase 2NCT00248014

Response of Individuals With Class II Malocclusion

A Phase 2 study testing Mandibular Advancement Via A Functional Appliance in people with CLASS II DIVISION 1 MALOCCLUSION, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This investigation aims at distinguishing the subjects that react in a favorable way to the treatment protocol we propose for the Class II treatment Read more about this study

Who is it for?
Ages 8 to 15 yearsHealthy volunteers can take part
Conditions the study is for
CLASS II DIVISION 1 MALOCCLUSION
What is being tested?
Mandibular Advancement Via A Functional Appliance
Type of treatment
Medical device
How many people
63 participants
Where
1 siteGreece
Study dates
Oct 2005to Apr 2009
Phase
Phase 2
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 8 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Class II Division 1 malocclusion
  • Crowding no more than 4 mm per side
  • Healthy subjects

Who cannot join

  • Hormonal imbalances
  • TMJ symptoms
  • Craniofacial abnormalities
  • Arthritis

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Orthodontic Clinic of Auth

    Thessaloniki, Macedonia, 54124

Other trials in Greece

About this study

Official title: Cephalometric Indicators of Biological Responsiveness to Orthodontic Treatment of Class II/I in Growing Patients

This investigation aims at distinguishing the subjects that react in a favorable way to the treatment protocol we propose for the Class II treatment

Read the detailed description

Class II Division 1 is a prevalent malocclusion. Many methods have been utilized to correct it.

The purpose of our prospective study is to clarify the specific cephalometric indicators of biological responsiveness that lead to a successful Class II Div.1 treatment in growing individuals. These indicators will hopefully assist in the differential diagnosis of a "true" and a "pseudo" Class II, that is a masked Class I, that we presume will be relatively easy to treat and stable a treatment result.

70 -100 subjects with a Class II/I malocclusion will be recruited and treated with the exact mode of treatment. As Class II we consider the one that is a t least half molar cusp Class II. Patients will already erupted lower first premolars will be included as we presume this is the approximate time of the maximum growth spurt which we want to exploit using the functional appliance. Crowding in both arches should not exceed 4 mm so as to exclude any denoalveolar changes due to alignment. Any tooth agenesis, besides the third molars, will exclude the subject from the study. The medical history of the patient should be non-contributory regarding any hormonal abnormalities, arthritis and pain from the TMJ. Syndromic patients and those exhibiting craniofacial abnormalities will be excluded.

The skeletal age of each patient will be assessed by observing the cervical column.

Every patient will have his records taken, the latter including a lateral ceph and a panoramic x-ray. Standard intra- and extra oral pictures will be taken as well (T0).

The treatment protocol includes a first phase of 3-4 months of slow palatal expansions utilizing a removable palatal plate with a 0.25 mm jackscrew in the middle (T1). The screw will be turned once a week for two weeks and then twice a week until the upper posterior teeth are over-expanded 2 mm per side. During phase II (T2)the patient will be asked to wear the same appliance adjusted as such to incorporate a tongue crib that will force the mandible into a Class I relationship acthing the way the know functional appliances work (eg activator). The crib will incorporate 4 loops in the canine area and will be placed so as not to impinge in the lower lingual gingival region but it will be long enough so as the patient will not be able to shift the mandible back. If the initial overjet exceeds 5 mm the mandibular advancement will be gradual. Further adjustments will be made so as to maintain the Class I relationship. The patient will wear the appliance for 8-12 months (T3). New records will be taken at that time. If braces are needed, the patient will continue with fixed appliances.

Being tested
Mandibular Advancement Via A Functional Appliance
Keywords
CLASS II, FUNCTIONAL APPLIANCE, MANDIBULAR ADVANCEMENT STABILITY
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.

  • Mandibular Advancement Via A Functional ApplianceDevice

    Functional appliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of Class I relationship

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionNov 2008
  4. Study completionApr 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248014
Sponsor's protocol ID
ORTHODONTICS 1
Status last verified
Jan 2012
First submitted
1 Nov 2005
Last updated
19 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mandibular Advancement Via A Functional Appliance in people with CLASS II DIVISION 1 MALOCCLUSION, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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 3 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: finished, as of the sponsor's last update on 19 Jan 2012. 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 Greece. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Achievement of Class I relationship (time frame: 18 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 19 Jan 2012.

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