Class II Division 1 Malocclusion Clinical Trial
Official title:
"Evaluation of Treatment Effects of Two Different Fixed Functional Appliances in Patients With Class II Div 1 Malocclusion Using CBCT- A Randomized Controlled Clinical Study"
The main objective of this prospective, controlled clinical study is:
1. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device in
patients with Class II divison1 malocclusion.
2. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device with
the control group.
The null hypothesis for this study is that Forsus and PowerScope2 are equally effective in
the treatment of ClassII div1 malocclusion.
Class II malocclusion is one of the most frequent problems in orthodontics ,as it affects one
third of patients seeking orthodontic treatment. McNamara reported mandibular retrusion as
the most common characteristic of Class II malocclusion rather than maxillary prognathism.
Functional orthopaedic appliances are widely used to treat Class II malocclusion in growing
patients .Contrary to removable appliances, fixed devices do not require patient
collaboration and can be worn in association with multibracket therepy, so that class II
malocclusion can be corrected in a single phase treatment.
.Most popular flexible devices are the Jasper Jumper, Eureka spring, and the Forsus device
(FRD)Forsus Fatigue Resistant Device [FRD]is a three piece (L pin module) or two-piece (EZ2
module) system, composed of a telescoping spring that attaches at upper first molar and a
push rod linked to lower archwire, distal to either the canine or first premolar bracket. The
FRD spring and rod create an equal and opposite force to maxillary and mandibular
dentition.1The clinical application of the FRD was described by Vogt in 2006.PowerScope is
one of the latest innovation in Class II correction developed by Dr. Andy Hayes. Inventors
claims the following advantages of powerscope over other functional appliances. It is
delivered as a one-size-fits-all appliance pre-assembled with attachment nuts for quick and
easy chairside application .
The appliance is a wire-to-wire installation with attachments placed mesial to the first
molar in the maxillary arch and distal to the canine of the mandibular arch. Internal NiTi
spring mechanism delivers 260 gms of force for continous activation during treatment.
The dental, skeletal and soft tissue short-term effects of comprehensive fixed appliance
treatment combined with ForsusTM in ClassII patients have been evaluated previously. However
no previous study compared the posttreatment effects of PowerScope2TM and ForsusTM.The
purpose of this controlled clinical study is to evaluate the treatment and posttreatment
effects induced by PowerScope2 in growing patients with ClassII malocclusion and to compare
it with Forsus(FRD) on CBCT.
The majority of the studies examined the changes of the upper airway through lateral
cephalometric radiography. This method limited the accuracy of airway measurement since the
two-dimensional (2D) images only allowed an anteroposterior dimension measurement in sagittal
plane, and failed to provide a full-scaled view of the upper airway. Therefore, 3D evaluation
of the upper airway in growing patients during fixed functional appliance treatment needs to
be established .Cone beam computed tomography (CBCT) is an acceptable technique for 3D
volumetric depiction and morphological evaluation of the upper airway using a lower-radiation
method with a greater spatial resolution . It allows 3D registration of pre- and
post-treatment data through identification of specific structures in the cranial base.
Therefore, the changes of the upper airway before and after mandibular advancement can be
precisely evaluated. As the patients involved in our research were underage, their normal
development may affect on the upper airway morphology during the treatment period. Thus, an
untreated control group is needed. In the present study, the control group was selected from
records of patients with the same diagnosis who just began orthodontic treatment, and matches
well with the post-treatment patients of fixed functional appliance group through age, sex
and development condition strategy, so that effects of fixed functional appliance on the
upper airway morphology can be evaluated.
MATERIALS AND METHODS- Ours is a prospective, non-pharmacological, double blind, randomized
controlled clinical study to compare the treatment effects of two different fixed functional
appliances, Forsus and PowerScope2. The present study will be conducted in the Department of
Orthodontics and Dentofacial Orthopedics, PGIDS, Pt. B.D. Sharma University of Health
Sciences, Rohtak.
Ethical clearance- The study will be carried out after the institutional approval for use in
humans.
Source of data:- The sample size consists of 63 subjects who were selected from the patients
attending regular OPD at the Department of Orthodontics and Dentofacial Orthopedics for
orthodontic treatment.
TARGET SAMPLE SIZE Nearly 21 subjects per group and 63 in total should be an ideal sample
size including 10% dropout for the proposed study to have a power of 90% and a standard error
of significance to be 0.05.
INFORMED CONSENT OF THE PATIENT AND AGREEMENT TO BE RANDOMISED A valid, informed written
consent of the patient or parent/ guardian and an agreement to be randomized was obtained
from the patient before registering the patient in this clinical study. Patient or parent/
guardian was informed about all the theoretical risks and benefits of the intervention under
test. Risks and hazards of radiation during CBCT were also explained to the patient.
INTERVENTION AND DESIGN OF STUDY
The main intervention in this clinical study is placement of 2 different fixed functional
appliances after initial levelling and alignment of dental arches. The study consists of 3
groups with equal allocation of subjects in each group-
G1- This group received Powerscope2 appliance bilaterally G2-This group received Forsus
bilaterally (as per size suitable for the individual.
G3-The control group wiil be selected from patients with same diagnosis who just began
orthodontic treatment, and matches well with the post treatment patients of Powerscope2 and
Forsus through age, sex and development condition.
Selection of subjects in intervention groups (patients meeting selection criteria)
Treatment with 0.022 MBT preadjusted edgewise appliance
Maxillary and mandibular arches will be stabilized with the help of 0.019" × 0.025" stainless
steel wire, reverse torque will be introduced in the lower anterior segment and wires will be
cinched back distal to 2ndmolars.
Patient were randomly allocated into 2 groups.
1 PowerScope2 (G1) 2. Forsus (G2)
Pretreatment diagnostic records including lateral cephalogram were taken. CBCT was taken
before insertion and after removal of the fixed functional appliance.
Insertion of fixed functional appliance as per the group allocated. Regular follow up till
the completion of functional phase of treatment will be done. Patients will undergo
functional appliance phase till Class I molar relationship is achieved.
RANDOMISATION & ALLOCATION CONCEALMENT The subjects were randomly allocated by a sealed
opaque envelope method. The study subjects were blinded regarding intervention group.
Allocated appliance was inserted on the patient.
DATA COLLECTION AND CBCT ANALYSIS
The investigator recorded the patients' name, address and contact number. CBCT will be
recorded before placement of fixed functional appliance and immediately after its removal in
order to evaluate changes caused by the functional appliances.
To check patient comfort, all patients were given a questionnaire to investigate the
patient's experiences with PowerScope2 and Forsus. The questionnaire was designed in English
and then verbally translated into the patients and parents native language at the
installation appointment though all the patients and their parents could read and understand
it in English.
Prefunctional and postfunctional profile photographs of the treatment groups (G1 and G2)
patients and those of control will be presented to 5 orthodontists, 5 patients, 5 parents and
5 laypersons.The raters will assess changes in facial appearance on a visual analog scale.
CBCT Data Acquisition The pre-treatment and post-treatment CBCT scans of two intervention
groups (G1 & G2) and the CBCT of control group (G3) will be collected and analysed.
During CBCT scan, patients will be instructed to maintain an upright posture and natural head
position. The CBCT scans will be performed at rest position of the tongue (tongue in contact
with anterior palate without touching the anterior teeth) and maximum intercuspation. All of
the scans will be performed by the same researcher.
DATA COLLECTION & INTERPRETATION Data will be collected, properly arranged and a CONSORT flow
chart will be made to derive final sample size and calculate number of exclusions.
Statistical analysis:-The data recorded will be processed by standard statistical analysis.
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