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Response of Individuals With Class II Malocclusion

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 3, 2005
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IOANNA GIDARAKOU, Aristotle University Of Thessaloniki
This investigation aims at distinguishing the subjects that react in a favorable way to the treatment protocol we propose for the Class II treatment

Condition Intervention Phase
CLASS II DIVISION 1 MALOCCLUSION Device: Mandibular Advancement Via A Functional Appliance Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cephalometric Indicators of Biological Responsiveness to Orthodontic Treatment of Class II/I in Growing Patients

Further study details as provided by IOANNA GIDARAKOU, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Achievement of Class I relationship [ Time Frame: 18 months ]

Enrollment: 63
Study Start Date: October 2005
Study Completion Date: April 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Mandibular Advancement Via A Functional Appliance
    Functional appliance
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.


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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion criteria:

  • Hormonal imbalances
  • TMJ symptoms
  • Craniofacial abnormalities
  • Arthritis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248014

Orthodontic Clinic of Auth
Thessaloniki, Macedonia, Greece, 54124
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

Responsible Party: IOANNA GIDARAKOU, Dr Ioanna Gidarakou, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00248014     History of Changes
Other Study ID Numbers: ORTHODONTICS 1
First Submitted: November 1, 2005
First Posted: November 3, 2005
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by IOANNA GIDARAKOU, Aristotle University Of Thessaloniki:

Additional relevant MeSH terms:
Malocclusion, Angle Class II
Tooth Diseases
Stomatognathic Diseases