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

• ClinicalTrials.gov Identifier: NCT03780764
• Recruitment Status: Completed
• First Posted: December 19, 2018
• Last Update Posted: December 20, 2018
• Sponsor: Jordan University of Science and Technology
• Information provided by (Responsible Party): Elham Abu Alhaija, Jordan University of Science and Technology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Orthodontic Appliances	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	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Conventional fixed appliance; 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; 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).
Experimental: Self ligating fixed appliance; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Pulpal blood flow changes by the use of Laser Doppler Flowmeter [ Time Frame: 20 minutes ,48 hours, 72 hours and 1 month ]
   millimeter per second

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 22 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Jordan

Jordan University of science and technology Dental Teaching Clinics

Irbid, Jordan

Sponsors and Collaborators

Jordan University of Science and Technology

More Information

• Responsible Party: Elham Abu Alhaija, Proffessor- Main investigator, Jordan University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03780764
• Other Study ID Numbers: 236/2016
• First Posted: December 19, 2018
• Last Update Posted: December 20, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elham Abu Alhaija, Jordan University of Science and Technology:

Pulpal blood flow; self ligating brackets; orthodontics