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

Orthodontic Appliances Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780764
• Other study ID #: 236/2016
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: December 2018
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliances

Intervention

Other:
• A 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).
• Self- 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.

Locations

Country	Name	City	State
Jordan	Jordan University of science and technology Dental Teaching Clinics	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulpal blood flow changes by the use of Laser Doppler Flowmeter	millimeter per second	20 minutes ,48 hours, 72 hours and 1 month