Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires

NCT ID: NCT04549948

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Orthodontic Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

0.017X0.025 Stainless steel

Intervention Type: PROCEDURE

Leveling curve of Sppe using 0.017X0.025 SS archwire

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.

Group Type: EXPERIMENTAL

0.019X0.025 Stainless steel

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

0.021X0.025 B-Titanium archwire

Intervention Type: PROCEDURE

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

Interventions

0.017X0.025 Stainless steel

Leveling curve of Sppe using 0.017X0.025 SS archwire

Intervention Type: PROCEDURE

0.019X0.025 Stainless steel

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

Intervention Type: PROCEDURE

0.021X0.025 B-Titanium archwire

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Elham Abu Alhaija

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elham S A Abu Alhaija, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology

Irbid, , Jordan

Countries

Jordan

References

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.

Reference Type: DERIVED

PMID: 36773128 (View on PubMed)

Other Identifiers

436/2018

Identifier Type: -

Identifier Source: org_study_id