NCT04549987

Brief Summary

The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 9, 2020

Last Update Submit

September 19, 2020

Conditions

Orthodontic Appliance

Keywords

Tooth movementFrictionRate

Outcome Measures

Primary Outcomes (1)

  • The amount of space closure per month

    the width of upper extraction space in milimeters

    3 months

Secondary Outcomes (2)

  • ion concentration in saliva

    through study completion, an average of 1 year

  • Frictional resistance

    At the end of the study

Study Arms (2)

Without changing working archwire

EXPERIMENTAL

Extraction space closed using the same working archwire throughout 3 visits after insertion

Device: Space closure without changing working archwire monthly

With changing working archwire

EXPERIMENTAL

The extraction space closed having the working archwire changed monthly.

Device: Space closure withchanging working archwire monthly

Interventions

Space closure without changing working archwire monthlyDEVICE

Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month

Without changing working archwire
Space closure withchanging working archwire monthlyDEVICE

Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month

With changing working archwire

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age ≥ 16 years
  • Proclined upper and lower incisors (Ui/max \>115 o, Li/mand \>99o)
  • Mild upper and lower arch crowding (\<4mm) or no crowding
  • Need for upper and lower first premolars extraction
  • Skeletal I malocclusion (1\<ANB \<5)
  • Average lower facial height and maxillomandibular plane angle (22 o \<MM\<32 o)
  • Class I canine relationship
  • Good oral hygiene and healthy periodontium

You may not qualify if:

  • Poor oral hygiene
  • Diseases and medications that were likely to affect bone biology
  • Previous orthodontic treatment
  • Evidence of bone loss
  • Active periodontal disease
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics

Irbid, Jordan

Location

Study Officials

  • Elham S A Alhaija, PhD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The intervention was randomly allocated to either the right or left side using the permuted random block size of 2 with 1:1 allocation ratio. The random sequences for each intervention to either right or left sides was concealed in opaque envelopes and shuffled before the intervention to increase the unpredictability of the random allocation sequence. Each patient was asked to pick a sealed envelope to assign the intervention to either the right or left side. Allocation concealment was aimed to prevent selection bias and to protect the assignment sequence until allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Working archwire status
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

December 1, 2018

Primary Completion

September 1, 2019

Study Completion

August 31, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)