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

Primary Purpose

Root Resorption

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

conventional brackets

smart clip passive self ligating brackets

Empower active self ligating brackets

About this trial

This is an interventional treatment trial for Root Resorption

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institute of Dental Studies & Technologies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

conventional brackets

Smart clip passive self ligating brackets

Empower active self ligating brackets

Arm Description

Conventional brackets with Mac Laughin bennette Trevisi (MBT) prescription

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

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

Outcomes

Primary Outcome Measures

root resorption

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03613285

First Posted

July 15, 2018

Last Updated

July 28, 2018

Sponsor

Institute of Dental Science and Technologies

1. Study Identification

Unique Protocol Identification Number

NCT03613285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

October 1, 2013 (Actual)

Primary Completion Date

November 1, 2015 (Actual)

Study Completion Date

December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Dental Science and Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Root Resorption

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

conventional brackets

Arm Type

Active Comparator

Arm Description

Conventional brackets with Mac Laughin bennette Trevisi (MBT) prescription

Arm Title

Smart clip passive self ligating brackets

Arm Type

Active Comparator

Arm Description

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

Arm Title

Empower active self ligating brackets

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

conventional brackets

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

smart clip passive self ligating brackets

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Empower active self ligating brackets

Intervention Description

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

Primary Outcome Measure Information:

Title

root resorption

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Puneet Batra, MDS

Organizational Affiliation

IDST

Official's Role

Study Chair

Facility Information:

Facility Name

Institute of Dental Studies & Technologies

City

Ghāziābād

State/Province

Uttar Pradesh

ZIP/Postal Code

201201

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Learn more about this trial

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

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