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Response of Individuals With Class II Malocclusion

Primary Purpose

CLASS II DIVISION 1 MALOCCLUSION

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Mandibular Advancement Via A Functional Appliance
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for CLASS II DIVISION 1 MALOCCLUSION focused on measuring CLASS II, FUNCTIONAL APPLIANCE, MANDIBULAR ADVANCEMENT STABILITY

Eligibility Criteria

8 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orthodontic Clinic of Auth

Outcomes

Primary Outcome Measures

Achievement of Class I relationship

Secondary Outcome Measures

Full Information

First Posted
November 1, 2005
Last Updated
January 18, 2012
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT00248014
Brief Title
Response of Individuals With Class II Malocclusion
Official Title
Cephalometric Indicators of Biological Responsiveness to Orthodontic Treatment of Class II/I in Growing Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLASS II DIVISION 1 MALOCCLUSION
Keywords
CLASS II, FUNCTIONAL APPLIANCE, MANDIBULAR ADVANCEMENT STABILITY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Via A Functional Appliance
Intervention Description
Functional appliance
Primary Outcome Measure Information:
Title
Achievement of Class I relationship
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EFFI BASDRA, PHD
Organizational Affiliation
ASSISTANT PROFESSOR
Official's Role
Study Director
Facility Information:
Facility Name
Orthodontic Clinic of Auth
City
Thessaloniki
State/Province
Macedonia
ZIP/Postal Code
54124
Country
Greece

12. IPD Sharing Statement

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Response of Individuals With Class II Malocclusion

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