Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates Using Cone Beam Computed Tomography

NCT03467555 | Completed DMC

• 1 other identifier: sonal tulika
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (4)

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

  distal movement of maxillary molars and central incisors before and after intervention measured in mm at crown and root levels on Cone Beam Computed Tomography

  24 months

• root resorption of maxillary teeth

  root resorption of maxillary incisors, canines, premolars and molars evaluated by measuring the root lengths along the long axis of the roots from cemento- enamel junction to the root tips in mm on Cone Beam Computed Tomography before and after intervention

  24 months

• patient experiences with zygomatic miniplates

  questionaires given to patients for evaluating patient attitude and pain perception (using Visual Analog Scale) at different time intervals.

  20 months

• soft tissue profile changes

  soft tissue profile changes after intervention 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

  30 months

Secondary Outcomes (4)

• mandibular plane angle

  24 months

• the movement of maxillary central incisors and molars in vertical plane

  24 months

• transverse changes

  24 months

• Airway changes

  24 months

Study Arms (1)

distalization group

EXPERIMENTAL

Class II correction using zygomatic miniplates

Device: Class II correction using miniplates in zygomatic region

Interventions

Class II correction using miniplates in zygomatic region DEVICE

distalization group

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sonal Chowdhary

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 16, 2018
• Study Start: December 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

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

Locations

IN (1)