Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

Study Overview
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Brief Summary
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to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.

Detailed Description
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Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).

Official Title
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Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial

Conditions
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Orthodontic Appliance

Intervention / Treatment
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* Procedure: 0.014-inch NiTi on one side /0.018-inch NiTi on the other side
* Procedure: 0.016-inch NiTi on one side /0.018-inch NiTi on the other side


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-25 years Class I skeletal malocclusion Mild lower arches crowding. Contact point displacement less than 2 mm. No previous orthodontic treatment Exclusion Criteria: Missing teeth Poor oral hygiene deep carious teeth history of previous trauma any medical conditions affecting blood vessels smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 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. Each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group 1:- 0.014-inch and 0.018-inch NiTi Group 2:- 0.016-inch and 0.018-inch NiTi.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.014/0.018 NiTi arch wire<br>0.014-inch NiTi on one side /0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients | Procedure: 0.014-inch NiTi on one side /0.018-inch NiTi on the other side<br>* Where each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.<br>|
| Experimental: 0.016/0.018 NiTi arch wire<br>0.016-inch NiTi on one side / 0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients | Procedure: 0.016-inch NiTi on one side /0.018-inch NiTi on the other side<br>* Where each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulpal blood flow changes | Measurements were taken by the use of Laser Doppler Flowmeter mm/s | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpal blood flow, Pfixed appliance, Alignment arch wire