Bilateral Premolar Extraction vs Distalization: A Randomised Clinical Trial

NCT04743258 | Unknown DMC

• 1 other identifier: SONAL SURJEET
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 .

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (4)

• skeletal angular changes

  SNA angle Pre \& Post after space closure in group 1 \& achieving Class I molar relation in group 2

  28 months

• Maxillary dentoalveolar changes

  maxillary incisor to NA angle Pre \& Post after space closure in group 1 \& achieving Class I molar relation in group 2

  28 months

• Soft tissue changes

  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

  34 months

• overjet & overbite measured in mm

  Pre \& Post after space closure in group 1 \& achieving Class I molar relation in group 2

  28 months

Secondary Outcomes (2)

• mandibular plane angle

  [Time Frame: 28 months]

• airway changes

  [Time Frame: 28 months]

Study Arms (2)

EXTRACTION

EXPERIMENTAL

treatment of class II div 1 malocclusion with bilateral maxillary premolar extraction

Procedure: MAXILLARY PREMOLAR EXTRACTION

DISTALIZATION

EXPERIMENTAL

treatment of class II div 1 malocclusion with distalization using zygomatic miniplates

Procedure: DISTALIZATION

Interventions

MAXILLARY PREMOLAR EXTRACTION PROCEDURE

Patients will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling \& alignment.

EXTRACTION

DISTALIZATION PROCEDURE

Maxillary arch will be distalized with the help Zygomatic miniplates will be placed bilaterally.

DISTALIZATION

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with a history of fixed orthodontic treatment.
• Crossbite
• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

SONAL CHOWDHARY, MDS

CONTACT

9992025599; sonalsingla@rediffmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: February 8, 2021
• Study Start: January 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IN (1)