NCT04387578

Brief Summary

The present prospective clinical study was directed to evaluate the efficiency of three different aligning archwires during initial orthodontic leveling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 5, 2020

Last Update Submit

May 12, 2020

Conditions

Dental MalocclusionDental Crowding

Keywords

Orthodontic arch wirealignmentGummetal arch wiremultistrand arch wire

Outcome Measures

Primary Outcomes (4)

  • evaluation of the alignment efficiency

    evaluation of the alignment efficiency among the three investigated arch wires via the measurement of the scores of Little's Irregularity Index

    three months of leveling and alignment

  • comparison of the alignment efficiency

    comparison of the alignment efficiency among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index

    three months of leveling and alignment

  • evaluation of the alignment rate

    evaluation of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index

    three months of leveling and alignment

  • comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index

    comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index

    three months of leveling and alignment

Secondary Outcomes (2)

  • evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.

    three months of leveling and alignment

  • comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.

    three months of leveling and alignment

Study Arms (3)

Group A singlestrand NiTi arch wires

EXPERIMENTAL

in which 10 patients (5 males and 5 females) were treated with round singlestrand NiTi arch wires in a sequence of 0.012, 0.014, and 0.016 inch.

Device: fixed orthodontic appliance and arch wires

Group B Gummetal arch wires

EXPERIMENTAL

in which 10patients (6 males and 4 females) were treated with niobium-titanium-tantalum-Zirconium arch wires (Gummetal arch wires) in a sequence of 0.014, 0.016, and 0.018 inch.

Device: fixed orthodontic appliance and arch wires

Group C multistrand NiTi arch wires

EXPERIMENTAL

in which 10 patients (4males and 6females) were treated with multistrand NiTi arch wires in a sequence of 0.016, 0.018, and 0.020 inch.

Device: fixed orthodontic appliance and arch wires

Interventions

fixed orthodontic appliance and arch wiresDEVICE

leveling and aligning stages in orthodontics

Group A singlestrand NiTi arch wiresGroup B Gummetal arch wiresGroup C multistrand NiTi arch wires

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • An age range from 15 to 20 years
  • All permanent teeth have erupted (3rd molar not included)
  • Angle class I malocclusion with normal facial proportions.
  • Moderate crowding in the lower dental arch that required treatment with fixed appliance using the non-extraction approach.
  • Good oral hygiene with healthy periodontium, good general health without any systematic disease that could affect the treatment.

You may not qualify if:

  • Severe crowding that requires an extraction approach.
  • A blocked-out tooth that prevent the easy placement of the bracket at the initial bonding appointment.
  • Poor oral hygiene or periodontal compromised teeth.
  • Relevant medical history and/or regular medication that contraindicates and/or interferes with orthodontic treatment.
  • Craniofacial anomalies or previous history of trauma, bruxism, or parafunction.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

MalocclusionCrowding

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Ahmed T Ali, Demonstrator

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 14, 2020

Study Start

September 1, 2018

Primary Completion

September 10, 2019

Study Completion

September 20, 2019

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)