Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248014
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2005-11-01
Brief Title:
Response of Individuals With Class II Malocclusion
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Cephalometric Indicators of Biological Responsiveness to Orthodontic Treatment of Class III in Growing Patients
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Div1 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 III 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 025 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 T2the 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
The purpose of our prospective study is to clarify the specific cephalometric indicators of biological responsiveness that lead to a successful Class II Div1 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 III 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 025 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 T2the 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None