Response of Individuals With Class II Malocclusion
Condition: CLASS II DIVISION 1 MALOCCLUSION
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 2

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
    

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.
    

Intervention name(s): Mandibular Advancement Via A Functional Appliance
Intervention type(s): Device
Intervention description(s): Functional appliance
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLASS II; FUNCTIONAL APPLIANCE; MANDIBULAR ADVANCEMENT STABILITY