NCT04191070

Brief Summary

The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with infrazygomatic miniscrews in comparison with zygomatic miniplate anchorage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

December 3, 2019

Last Update Submit

June 9, 2020

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (5)

  • distal movement of maxillary molars and central incisors measured in mm at crown and root levels

    . distal movement of maxillary molars and central incisors measured in mm at crown and root levels achieved with infrazygomatic crest miniscrew in comparison with zygomatic miniplates on Cone Beam Computed Tomography

    28 months

  • root resorption of maxillary teeth

    root resorption of maxillary incisors, canines, premolars and molars evaluated on Cone Beam Computed Tomography before and after distalization with infrazygomatic crest miniscrew in comparison with zygomatic miniplates

    28 months

  • patient experiences and quality of life with zygomatic miniplates and infrazygomatic crest miniscrews

    patient experiences and quality of life with zygomatic miniplates and infrazygomatic crest miniscrew assessed using questionnaires given to patients for evaluating patient attitude,pain perception and quality of life at different time intervals.

    34 months

  • soft tissue profile 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

  • occlusal status comparison

    occlusal status changes pre and post treatment will be assessed using PAR index(peer assessment rating between 2 groups)

    34 months

Secondary Outcomes (4)

  • mandibular plane angle

    28 months

  • movement of maxillary central incisors and molars in vertical plane

    28 months

  • transverse changes

    28 months

  • airway changes

    28 months

Study Arms (2)

Class II correction using infrazygomatic crest miniscrews

EXPERIMENTAL

class II correction by distalization using infrazygomatic crest miniscrews (G1)

Device: infrazygomatic miniscrew

Class II correction using zygomatic miniplates

EXPERIMENTAL

class II correction by distalization using zygomatic miniplates (G2)

Device: zygomatic miniplate

Interventions

infrazygomatic miniscrewDEVICE

class II correction by distalization using infrazygomatic crest miniscrew

Class II correction using infrazygomatic crest miniscrews
zygomatic miniplateDEVICE

class II correction by distalization using zygomatic miniplate

Class II correction using zygomatic miniplates

Eligibility Criteria

Age17 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non growing patients
  • Bilateral Class II molar relationship, defined by at least end-to-end molar relationship.
  • No or minor crowding in the mandible.
  • Treatment completion without any permanent teeth extracted (excluding third molars).
  • Both 1st and 2nd maxillary molars present on the side with a Class II relationship.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 9, 2019

Study Start

January 1, 2019

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

IN(1)