Evaluation of Profile Changes and Torque Control in Dental Bimaxillary Proclination Cases Using Lingual Lever Arm Mechanics vs Conventional Lingual Orthodontic Mechanics A Randomized Controlled Trial

June 26, 2018 updated by: Ahmed Kandil, Cairo University
This study evaluates the profile changes and torque control using lingual lever arm vs conventional lingual mechanics. Half of the patients will receive lever arms and the other half will receive conventional lingual orthodontics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Conventional lingual orthodontic biomechanics leads to torque loss during en masse retraction of the anterior segment in the bimaxillary proclination cases treated by first premolar extraction. Torque loss affects the final outcome of the treatment negatively.

Adding a lever arm to the lingual wire will transmit the point of force application at or apical to the center of rotation which will reduce or eliminate toqrue loss during anterior segment retraction.

Study Type

Interventional

Enrollment (Anticipated)

24

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 Contact

Study Contact Backup

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female adult patients with age range 18-30 yrs old.
  • Class I bimaxillary dentoalveolar proclination.
  • Full permanent dentition.
  • Good oral hygiene.
  • Maximum anchorage is required.
  • Healthy bone around the first molars is needed.

Exclusion Criteria:

.Systemic disease.

  • Severe crowding.
  • Extracted or missing upper permanent tooth/teeth (except for third molars).
  • Signs, symptoms or previous history of temporomandibular disorders (TMD).
  • Previous orthodontic treatment.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional lingual mechanics
Procedure: Lingual orthodontics
A coil spring will be attached from the lever arm to the first molar tube
Other Names:
  • Conventional lingual mechanics
Experimental: Lever arm lingual mechanics
Procedure: Lingual orthodontics
A coil spring will be attached from the lever arm to the first molar tube
Other Names:
  • Conventional lingual mechanics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasolabial angle
Time Frame: 12 months
Soft tissue lateral cephalometric radiograph measurement
12 months
Profile convexity reduction
Time Frame: 12 months
N'-sn -Pog' soft tissue angle
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Torque control
Time Frame: 12 months
U1 - Palatal plane angle
12 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Amr Abuelezz, Professor, Cairo University

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 (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AKandil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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