Changes in Pulpal Blood Flow Between Conventional and Self-ligating Fixed Orthodontic Brackets During Leveling and Alignment Stage

Not Applicable

Completed

• Conditions: Orthodontic Appliances

• Registration Number: NCT03780764
• Lead Sponsor: Jordan University of Science and Technology

Brief Summary

- Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.

Detailed Description

Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.

Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-05-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Both male and female subjects
• 6 or more years old
• Class I skeletal malocclusion
• mild lower arch crowding.

Exclusion Criteria

• Poor oral hygiene
• Previous orthodontic treatment
• Active periodontal disease
• Missing teeth, deep carious teeth
• Teeth with root resorption
• Endodontically treated teeth
• History of previous trauma
• Restoration on measured teeth
• Medical conditions affecting blood vessels and
• smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulpal blood flow changes by the use of Laser Doppler Flowmeter	20 minutes ,48 hours, 72 hours and 1 month	millimeter per second

Trial Locations

Locations (1)

Jordan University of science and technology Dental Teaching Clinics; 🇯🇴 Irbid, Jordan