Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires

Orthodontic Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549948
• Other study ID #: 436/2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Treatment

Intervention

Procedure:
• 0.017X0.025 Stainless steel
Leveling curve of Sppe using 0.017X0.025 SS archwire
• 0.019X0.025 Stainless steel
Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire
• 0.021X0.025 B-Titanium archwire
Leveling curve of Sppe using 0.019X0.025 B-Titanium archwire

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Curve of Spee depth changes during leveling	The change in Curve of Spee in millimetres	4 to 6 months
Secondary	Pain perception	A10-point visual analogue scale of 10 cm length where 0 indicate no pain and 10 indicate intolerable pain	one week
Secondary	Root Resorption	change in root length in millimeters	6 months
Secondary	Pulpal blood flow	Change in blood flow using laser flowmetry	one month