A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets

July 28, 2018 updated by: Rehana Bashir, Institute of Dental Science and Technologies
Aim: The aim of the study was to evaluate and compare the extent of root resorption in the maxillary and mandibular anterior teeth during orthodontic treatment with the use of different types of brackets. Materials and methods: The study consisted of 21 patients (11 males and 10 females) within the age group of 16-25 years, having bimaxillary protrusion. They were divided into three groups. In Group 1- Conventional brackets, Group 2- Self-ligation brackets:Smart Clip (Passive), and in Group 3 Self-ligation brackets: Empower (Active) were bonded. Computed Tomography scans and Orthopantomograms were taken before start of treatment and after six months of retraction. Root resorption is computed as the difference between the pre treatment total tooth length and the post treatment total tooth length.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Ghāziābād, Uttar Pradesh, India, 201201
        • Institute of Dental Studies & Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients having complete root formation at start of treatment,

Exclusion Criteria:

  • Patients with skeletal or dental anomalies .
  • Patients having history of root resorption
  • Patients having any systemic or metabolic anomalies,
  • Patients with trauma of anterior teeth
  • Patients with periapical inflammation of the anterior teeth
  • Patients with impacted teeth
  • Patients with tumors and cysts in the examined area
  • Patients having undergone orthodontic treatment previously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional brackets
Conventional brackets with Mac Laughin bennette Trevisi (MBT) prescription
Device: conventional brackets
conventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
ACTIVE_COMPARATOR: Smart clip passive self ligating brackets
Smart clip passive self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription
Device: smart clip passive self ligating brackets
smart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
ACTIVE_COMPARATOR: Empower active self ligating brackets
Empower active self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription
Device: Empower active self ligating brackets
Empower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
root resorption
Time Frame: 6 months
Computed Tomography scans were taken before start of treatment and after six months of retraction.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Dental Science and Technologies

Investigators

  • Study Chair: Puneet Batra, MDS, IDST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 15, 2018

First Submitted That Met QC Criteria

July 28, 2018

First Posted (ACTUAL)

August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDST/ERBC/2013/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will decide on case by case basis and as if our institution allows so

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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