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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03780764
Enrollment
22
Registered
2018-12-19
Start date
2017-06-01
Completion date
2018-05-01
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliances

Keywords

Pulpal blood flow, self ligating brackets, orthodontics

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.

Interventions

OTHERA Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022 Roth prescription brackets

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).

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

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.

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
16 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pulpal blood flow changes by the use of Laser Doppler Flowmeter20 minutes ,48 hours, 72 hours and 1 monthmillimeter per second

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026