Class II Division 1 Malocclusion Clinical Trial
Official title:
Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates: a Clinical Study Using Cone Beam Computed Tomography
The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with miniplate anchorage.
Premolar extraction treatment with multibracketed system and reinforced anchorage has been a
common modality for correcting maxillary incisor crowding or Class II malocclusion in
nongrowing patients. Treatment of Class II malocclusion without extraction frequently
requires distalization of maxillary molars into Class I relation by means of extraoral or
intraoral forces. Previously, it had been difficult to move maxillary molars distally after
full eruption of maxillary 2nd molars. Extraoral headgear traction restricting the forward
growth of maxilla and /or distalizing the maxillary dentition has been the most commonly used
and oldest method to correct a Class II buccal segment molar relationship.This distalizes not
only 1st molar but also maxillary 1st and 2nd premolars via transeptal fibers. Headgear is
seldom an option in adults due to aesthetics and compliance concerns. The disadvantages of
extraoral appliances have motivated many investigators to develop the mechanics of intraoral
molar distalization.
Various intraoral non compliance appliances like nickel-titanium spring , magnets , distal
jet , pendulum appliances have been used to distalize maxillary molars. However, in these
appliances, anchorage loss characterized by protrusion of maxillary incisors and an increase
in overjet is seen. Also considerable amount of relapse occurred when the distalized molars
were used as anchorage for the retraction of anteriors and premolar teeth.
Absolute skeletal anchorage available 24 hours a day is an alternative method for molar
distalization. It provides stationary anchorage for various tooth movements without the need
for active patient compliance and with no undesirable side effects. Miniscrews, which are
generally placed between the roots, limit the amount of distalization possible as they come
in contact with surrounding roots during tooth movement. Also, proximity of miniscrews to the
roots may lead to failure of screw anchorage .These disadvantages can be overcome by the use
of miniplates which are fixed at a distance from the root apices, and therefore do not
interfere in tooth movement.
Until now, there have been only a few clinical studies on group distalization of posterior
teeth. Thus, little information is available regarding the type of tooth movement that occurs
and the limitations of distal movement. An attempt was also not made to study the root
resorption and the amount of distal movement or tipping of maxillary 2nd molars since lateral
cephalometric radiographs do not provide a clear view of this region.
To the best of our knowledge, no previous study has been conducted on Cone Beam Computed
Tomography to evaluate the amount of distal movement of entire maxillary dentition using
miniplates placed in zygomatic region and assess the root resorption in all the roots of
maxillary molars. The purpose of this study is to evaluate distal movement of maxillary
dentition using Cone Beam Computed Tomography to overcome the shortcomings of the previous
studies.
MATERIALS AND METHOD Ours is a prospective clinical study to evaluate the distal movement of
maxillary dentition achieved in three dimensions with miniplates placed in zygomatic region
for the purpose of anchorage. The present study will be conducted in the Department of
Orthodontics and Dentofacial Orthopaedics, in conjunction with Department of Oral and
Maxillofacial Surgery, P.G.I.D.S., Pt. B.D.Sharma University of Health Sciences, Rohtak. The
study will be carried out after the institutional approval obtained from the ethical
committee.
SOURCE OF DATA The sample size consists of 20 subjects selected from the patients attending
the regular Out Patient Department at the Department of Orthodontics and Dentofacial
Orthopaedics for orthodontic treatment.
TARGET SAMPLE SIZE A sample size of 17 for the present study was calculated at 90% power.To
compensate for 10% dropouts the final sample size was calculated to be 20.
INTERVENTION AND DESIGN OF STUDY The main intervention in this clinical trial is surgical
placement of zygomatic miniplates after initial leveling and alignment of maxillary dental
arch. After selection of subjects (patients meeting selection criteria), treatment with
0.022" MBT preadjusted edgewise appliance was started. Maxillary arch will be stabilized with
the help of 0.019" × 0.025" stainless steel wire. Pre-treatment diagnostic records and Cone
Beam Computed Tomography will be taken before placing miniplates . Maxillary 3rd molars will
be extracted, if present . L shaped 2mm titanium miniplates (OrthoMax,Vadodara , India) will
be surgically placed under local anaesthesia in aseptic conditions at zygomatic region
bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed
coil spring/Elastomeric chain will be used to apply a force on both sides (calibrated using
Dontrix Gauge ) from miniplates to soldered hooks. Patient will be recalled at 4 weeks
interval. Records including Cone Beam Computed Tomography will be taken on achievement of
Class I molar relation bilaterally. Lateral cephalograms and CBCT will be taken 2 years post
retention.
DATA COLLECTION AND CONE BEAM COMPUTED TOMOGRAPHY ANALYSIS The investigator will record the
patients' name, address, contact number and other relevant case history records will be
taken. Cephalometric radiographs and Cone Beam Computed Tomography and will be recorded
before placement of zygomatic miniplates, on achievement of Class I molar relation
bilaterally and 2 years post retention for assessment of distalization. These records will be
analyzed. The relevant values will be entered in a predesigned format. Soft tissue profile
changes between pretreatment and post treatment will be assessed on lateral cephalogram and
the raters- orthodontist, laypersons,patients,parents and general dentists will assess
changes in facial appearance on a visual analog scale with profile photographs. Patient
perception will be assessed using questionnaire rating by patient regarding various
parameters at 1 week, 2 weeks, 1 month and 6 months after the placement of miniplate in
zygomatic region. Changes in the upper-airway size will be measured by using lateral
cephalometric radiographs taken before and after distalization.
INFORMED CONSENT OF THE PATIENT A valid, informed written consent of the patient or parent/
guardian will be obtained from the patient before registering the patient in this clinical
study . Patient will be informed about all the theoretical risks and benefits of the
intervention under test .Risks and hazards of radiation during CBCT will also be explained to
the patient. The patient will be given 72 hours to discuss the study with his/her family and
take the decision regarding participation in the study
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