NCT03579745

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Status
unknown

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

First Submitted

Initial submission to the registry

June 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 9, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

June 26, 2018

Last Update Submit

June 26, 2018

Conditions

Bimaxillary Proclination

Keywords

lingual orthodonticsLever armEn masse retraction

Outcome Measures

Primary Outcomes (2)

  • Nasolabial angle

    Soft tissue lateral cephalometric radiograph measurement

    12 months

  • Profile convexity reduction

    N'-sn -Pog' soft tissue angle

    12 months

Secondary Outcomes (1)

  • Torque control

    12 months

Study Arms (2)

Conventional lingual mechanics

ACTIVE COMPARATOR
Procedure: Lingual orthodontics

Lever arm lingual mechanics

EXPERIMENTAL
Procedure: Lingual orthodontics

Interventions

Lingual orthodonticsPROCEDURE

A coil spring will be attached from the lever arm to the first molar tube

Also known as: Conventional lingual mechanics
Conventional lingual mechanicsLever arm lingual mechanics

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Amr Abuelezz, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Ahmed Kandil Al Asfar, Masters

CONTACT

01008087762Kandilahmed04@gmail.com

Sherif Kordy, PhD

CONTACT

01224015821sherif-kordi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 9, 2018

Study Start

October 1, 2018

Primary Completion

November 1, 2019

Study Completion

June 1, 2020

Last Updated

July 9, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share