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

NCT03780764 | Completed

• 1 other identifier: 236/2016
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliances

Keywords

Pulpal blood flow; self ligating brackets; orthodontics

Outcome Measures

Primary Outcomes (1)

• Pulpal blood flow changes by the use of Laser Doppler Flowmeter

  millimeter per second

  20 minutes ,48 hours, 72 hours and 1 month

Study Arms (2)

Conventional fixed appliance

ACTIVE COMPARATOR

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

Self ligating fixed appliance

EXPERIMENTAL

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

Interventions

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

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).

Conventional fixed appliance

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

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.

Self ligating fixed appliance

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Both male and female subjects
• or more years old
• Class I skeletal malocclusion
• mild lower arch crowding.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of science and technology Dental Teaching Clinics

Irbid, Jordan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor- Main investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 19, 2018
• Study Start: June 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: May 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

JO (1)