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Completed

NCT Number: NCT04549948

Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires

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.

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Key information

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.017X0.025 Stainless steel

Procedure

Leveling curve of Sppe using 0.017X0.025 SS archwire

0.019X0.025 Stainless steel

Procedure

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

0.021X0.025 B-Titanium archwire

Procedure

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

Primary outcomes

  1. Curve of Spee depth changes during leveling

    Time frame: 4 to 6 months

    The change in Curve of Spee in millimetres

Secondary outcomes

  1. Pain perception

    Time frame: one week

    A10-point visual analogue scale of 10 cm length where 0 indicate no pain and 10 indicate intolerable pain

  2. Root Resorption

    Time frame: 6 months

    change in root length in millimeters

  3. Pulpal blood flow

    Time frame: one month

    Change in blood flow using laser flowmetry

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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