Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires

Curve of Spee: Speed of Leveling Using Different Orthodontic Archwire Size and Material - A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Treatment
• Intervention / Treatment: Procedure: 0.017X0.025 Stainless steel; Procedure: 0.019X0.025 Stainless steel; Procedure: 0.021X0.025 B-Titanium archwire

Detailed Description

Fifty one subjects with an excessive COS were included in this study. The subjects will be randomly divided into three groups; Group one (17 patients): leveling of COS using 0.017X0.025-inch stainless steel archwire. Group two (17 patients): leveling of COS using 0.019X0.025-inch stainless steel archwire. Group three (17 patients): leveling of COS using 0.021X0.025-inch Titanium molybdenum archwire.

In the three groups, a 5mm depth reverse COS will be inserted. Records consisted of lateral cephalograms (pre-treatment, at T0 and post-treatment), peri-apical radiographs (at T0 and at T5), study casts (pre-treatment and at each time point during the tudy). Patients will be followed up on monthly visits without removing leveling archwires where alginate impressions were taken for the lower arch. Pain scores during the first week of leveling will be recorded using visual analogue scale (VAS).The amount of COS correction in mm, changes in intercanine in mm, intermolar and arch length in mm, pain scores and lower incisors root resorptions in mm will be measured.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Jordan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.017X0.025 Stainless Steel Archwire; 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; Leveling curve of Sppe using 0.017X0.025 SS archwire
EXPERIMENTAL: 0.019X0.025 Stainless Steel Archwire; 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; Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire
EXPERIMENTAL: 0.021X0.025 TMA archwire; 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; Leveling curve of Sppe using 0.019X0.025 B-Titanium archwire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curve of Spee depth changes during leveling	The change in Curve of Spee in millimetres	4 to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	A10-point visual analogue scale of 10 cm length where 0 indicate no pain and 10 indicate intolerable pain	one week
Root Resorption	change in root length in millimeters	6 months
Pulpal blood flow	Change in blood flow using laser flowmetry	one month

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Elham S A Abu Alhaija, PhD, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: pain; root resorption; pulpal blood flow
• Other Study ID Numbers: 436/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No