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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

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ClinicalTrials.gov Identifier: NCT03579745
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Kandil, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bimaxillary Proclination Procedure: Lingual orthodontics Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

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 Name: 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 Name: Conventional lingual mechanics




Primary Outcome Measures :
  1. Nasolabial angle [ Time Frame: 12 months ]
    Soft tissue lateral cephalometric radiograph measurement

  2. Profile convexity reduction [ Time Frame: 12 months ]
    N'-sn -Pog' soft tissue angle


Secondary Outcome Measures :
  1. Torque control [ Time Frame: 12 months ]
    U1 - Palatal plane angle



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579745


Contacts
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Contact: Ahmed Kandil Al Asfar, Masters 01008087762 ext 20 Kandilahmed04@gmail.com
Contact: Sherif Kordy, PhD 01224015821 ext 20 sherif-kordi@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Amr Abuelezz, Professor Cairo University

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Responsible Party: Ahmed Kandil, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03579745     History of Changes
Other Study ID Numbers: AKandil
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Kandil, Cairo University:
lingual orthodontics
Lever arm
En masse retraction