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

Jordan University of Science and Technology

Status: Completed

Conditions: Orthodontic Appliances

Treatments: Other: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets; Other: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets

Study type: Interventional

Funder types: Other

Identifiers

NCT03780764

236/2016

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 16 to 22 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Conventional fixed appliance

Active Comparator group

Description:

A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch.

Treatment:

Other: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets

Self ligating fixed appliance

Experimental group

Description:

Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side.

Treatment:

Other: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets