NCT03613285

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

July 15, 2018

Last Update Submit

July 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • root resorption

    Computed Tomography scans were taken before start of treatment and after six months of retraction.

    6 months

Study Arms (3)

conventional brackets

ACTIVE COMPARATOR

Conventional brackets with Mac Laughin bennette Trevisi (MBT) prescription

Device: conventional brackets

Smart clip passive self ligating brackets

ACTIVE COMPARATOR

Smart clip passive self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription

Device: smart clip passive self ligating brackets

Empower active self ligating brackets

ACTIVE COMPARATOR

Empower active self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription

Device: Empower active self ligating brackets

Interventions

conventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

conventional brackets

smart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

Smart clip passive self ligating brackets

Empower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

Empower active self ligating brackets

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Patients having complete root formation at start of treatment,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Dental Studies & Technologies

Ghaziabad, Uttar Pradesh, 201201, India

Location

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • Puneet Batra, MDS

    IDST

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2018

First Posted

August 3, 2018

Study Start

October 1, 2013

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2018

Record last verified: 2018-07

Locations