Evaluation of Treatment Changes in Class II Div 1 Malocclusion With Bilateral Extraction of Maxillary First Premolars vs Full Arch Distalization: A Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Soft tissue changes
Study Overview
Brief Summary
Rationale: Class II Division 1 malocclusion is characterized by upper anterior teeth protrusion resulting in upper lip protrusion and convex facial profile, which are considered esthetically unfavorable. Treatment of class II malocclusion due to maxillary protrusion can be done with bilateral maxillary first premolar extraction followed by en-masse retraction of upper anterior teeth using mini implants placed between maxillary 2nd premolar & 1st molar.
Treatment of class II malocclusion due to maxillary protrusion without premolar extraction frequently requires distalization of maxillary molars into Class I molar relation by means of extra-oral or intraoral forces. Absolute skeletal anchorage, available 24 hours a day is an alternative method for molar distalization. Zygomatic miniplates fixed at a distance from the root apices, allows distalization of entire dentition as there is no interference between the fixation device and roots of the teeth.
Aims and Objectives: To evaluate dental, skeletal & soft tissue changes achieved with maxillary premolar extraction vs full arch distalization.
Method of study: Patients will be allocated randomly to 2 groups-G1 and G2. Patients in G1 will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling & alignment. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Hooks will be soldered on archwire used for stabilizing dentition. Mini implants will be placed under local anaesthesia between maxillary 2nd premolar & 1st molar. Ni-Ti closed coil spring will be used to apply a force for en masse retraction of maxillary anterior teeth .
In G2, treatment will be initiated by bonding 0.022" slot MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Zygomatic miniplates will be placed bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply a force .
Detailed Description
The present study is a prospective, non-pharmacological, single blind, randomized clinical study to evaluate the skeletal, dental and soft tissue changes with distalization of entire maxillary dentition using bilateral maxillary 1st premolar extraction in comparison with zygomatic miniplates in class II division 1 patients. The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, in conjunction with the 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 study sample consists of 34 subjects selected from the patients attending the regular OPD at the Department of Orthodontics and DentofacialOrthopaedics for orthodontic treatment.
INCLUSION CRITERIA
- Non growing patients
- Complete bilateral Class II molar relationship at pre-treatment
- All permanent teeth upto the second molars should be present
- No or minor crowding in the maxillary arch
- Horizontal to average growth pattern.
EXCLUSION CRITERIA
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non growing patients
- •Complete bilateral Class II molar relationship at pre-treatment
- •All permanent teeth upto the second molars should be present
- •No or minor crowding in the maxillary arch
- •Horizontal to average growth pattern.
Exclusion Criteria
- •Subjects with a history of fixed orthodontic treatment.
- •Vertical growth pattern
- •Any systemic disease affecting bone and general growth
- •Poor oral hygiene
- •Cleft patients
- •Patients who fail to follow up or undergo complete treatment
Outcomes
Primary Outcomes
Soft tissue changes
Time Frame: 34 months
soft tissue profile changes after distalization evaluated 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
overjet & overbite measured in mm
Time Frame: 28 months
Pre \& Post after space closure in group 1 \& achieving Class I molar relation in group 2
skeletal angular changes
Time Frame: 28 months
SNA angle Pre \& Post after space closure in group 1 \& achieving Class I molar relation in group 2
Maxillary dentoalveolar changes
Time Frame: 28 months
maxillary incisor to NA angle Pre \& Post after space closure in group 1 \& achieving Class I molar relation in group 2
Secondary Outcomes
- mandibular plane angle([Time Frame: 28 months])
- airway changes([Time Frame: 28 months])