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

Study Overview
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Brief Summary
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- 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
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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.

Official Title
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Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances

Conditions
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Orthodontic Appliances

Intervention / Treatment
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* Other: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022 Roth prescription brackets
* Other: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022 Roth prescription brackets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional fixed appliance<br>A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022 Roth prescription brackets) on one side of lower arch. | Other: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022 Roth prescription brackets<br>* A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022 Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016 NiTi arch wire until 0.016X0.022 NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8).<br>|
| Experimental: Self ligating fixed appliance<br>Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022 Roth prescription brackets) on the other side. | Other: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022 Roth prescription brackets<br>* Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022 Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016 NiTi arch wire until 0.016X0.022 NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulpal blood flow changes by the use of Laser Doppler Flowmeter | millimeter per second | 20 minutes ,48 hours, 72 hours and 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpal blood flow, self ligating brackets, orthodontics