NCT04549948

Brief Summary

The objectives if this study was to evaluate the efficacy of 3 different rectangular archwires in the correction of the curve of Spee (COS), to record the time needed to level excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes in intercanine and intermolar widths and arch length during leveling, to measure the arterio-posterior and vertical movement for the lower incisors and lower molars, to record pulpal blood flow and to detect the root resorption in the lower anterior teeth associated with leveling excessive COS using the 3 different archwires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2 months 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

10 months

First QC Date

September 9, 2020

Last Update Submit

September 19, 2020

Conditions

Orthodontic Treatment

Keywords

root resorptionpainpulpal blood flow

Outcome Measures

Primary Outcomes (1)

  • Curve of Spee depth changes during leveling

    The change in Curve of Spee in millimetres

    4 to 6 months

Secondary Outcomes (3)

  • Pain perception

    one week

  • Root Resorption

    6 months

  • Pulpal blood flow

    one month

Study Arms (3)

0.017X0.025 Stainless Steel Archwire

EXPERIMENTAL

Leveling of COS using 0.017X0.025 Stainless Steel (SS) Archwire A reverse COS using 0.017X0.025 SS was used to correct the excessive COS in the lower arch.

Procedure: 0.017X0.025 Stainless steel

0.019X0.025 Stainless Steel Archwire

EXPERIMENTAL

A reverse COS using 0.019X0.025 SS was used to correct the excessive COS in the lower arch.

Procedure: 0.019X0.025 Stainless steel

0.021X0.025 TMA archwire

EXPERIMENTAL

A reverse COS using 0.021X0.025 TMA archwire was used to correct the excessive COS in the lower arch.

Procedure: 0.021X0.025 B-Titanium archwire

Interventions

0.017X0.025 Stainless steelPROCEDURE

Leveling curve of Sppe using 0.017X0.025 SS archwire

0.017X0.025 Stainless Steel Archwire
0.019X0.025 Stainless steelPROCEDURE

Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire

0.019X0.025 Stainless Steel Archwire
0.021X0.025 B-Titanium archwirePROCEDURE

Leveling curve of Sppe using 0.019X0.025 B-Titanium archwire

0.021X0.025 TMA archwire

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 16 years and ≤ 30 years
  • Overbite covering more than half of the lower incisor height
  • Curve of Spee ≥ 4 millimeters
  • Mild crowding in lower arch where non-extraction treatment is indicated.
  • Normally inclined or retroclined lower incisors
  • Averaged or reduced lower vertical height
  • Good oral hygiene and healthy periodontium
  • All permanent teeth are present except for the third molars

You may not qualify if:

  • Severe crowding in lower arch where extraction treatment is indicated.
  • Missing permanent molars or Premolars
  • Poor oral hygiene and Periodontal disease
  • Systemic health problems and medications were taken
  • History of previous orthodontic treatment
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

Related Publications (1)

  • Ba-Hattab R, Abu Alhaija ES, Nasrawi YH, Taha N, Daher H, Daher S. Leveling the curve of Spee using different sized archwires: a randomized clinical trial of blood flow changes. Clin Oral Investig. 2023 Jun;27(6):2943-2955. doi: 10.1007/s00784-023-04894-7. Epub 2023 Feb 11.

    PMID: 36773128DERIVED

MeSH Terms

Conditions

Root ResorptionPain

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elham S A Abu 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 patient was blinded to the intervention used. However, it was not possible to blind the clinician during treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Leveling of the curve of Spee
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 30, 2019

Study Completion

June 30, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

JO(1)