NCT04686617

Brief Summary

The aim of this study was to investigate the effect of mechanical vibration on root resorption with or without the application of orthodontic force. Twenty patients who required maxillary premolar extractions as part of their orthodontic treatment were randomly separated into two groups of 10: no-force group and force group. Using a split-mouth procedure, each patient's maxillary first premolar teeth were randomly assigned as either vibration or control side in both groups. Buccally directed vibration of 113 Hz, using an Oral-B HummingBird device with a modified tip, was applied to the maxillary first premolar for 10 mins/day during 12 weeks. After the force application period, the maxillary first premolars were extracted and scanned with micro-computed tomography. Fiji(ImageJ) which made slice-by-slice quantitative volumetric measurements was used for resorption crater calculation. Total crater volumes was compared with Wilcoxon and Mann-Whitney U tests.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

December 17, 2020

Last Update Submit

December 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Orthodontically induced inflammatory root resorption (OIIRR)

    Orthodontically induced inflammatory root resorption (OIIRR) or, as it is better known, root resorption, is an unavoidable pathologic consequence of orthodontic tooth movement. It is a certain adverse effect of an otherwise predictable force application.

    12 weeks

Study Arms (2)

No-force group

NO INTERVENTION

The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction on one side and the other side was used as the premolar tooth control group. Oral B HummingBird device (Procter\&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks. At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

Force Group

ACTIVE COMPARATOR

The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction to one side and the other side was used as the premolar tooth control group. As in no-force group, same device procedure was used for the application of vibration. Self-ligating Speed (Strite Industries, Cambridge, Ontario, Canada) tubes and brackets with 0.022×0.026 inch slots were bonded to the buccal surfaces of the right and left first molar teeth and first premolar teeth.150g of buccally directed forces, producing by a 0.017×0.025-in beta-titanium-molybdenum alloy (3M Unitek, Monrovia, Calif) cantilever spring, were applied to premolar teeth on both side.The force magnitude was measured with a strain gauge (Dentaurum). At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

Diagnostic Test: Mechanical Vibration

Interventions

Mechanical VibrationDIAGNOSTIC_TEST

Oral B HummingBird device (Procter\&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks.

Force Group

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage) and fixed appliance treatment
  • Permanent dentition
  • Completion of apexification
  • Similar minimal crowding on each side of the maxillary arch

You may not qualify if:

  • Previous orthodontic or orthopedic treatment
  • Unilateral or bilateral posterior crossbites
  • Craniofacial anomaly
  • History of trauma, bruxism, or parafunction
  • Past or present signs and symptoms of periodontal disease
  • Significant medical history that would affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • History of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Khaja Y, Cobourne MT. Effects of supplemental vibrational force on space closure, treatment duration, and occlusal outcome: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Apr;153(4):469-480.e4. doi: 10.1016/j.ajodo.2017.10.021.

    PMID: 29602338BACKGROUND
  • Liao Z, Elekdag-Turk S, Turk T, Grove J, Dalci O, Chen J, Zheng K, Ali Darendeliler M, Swain M, Li Q. Computational and clinical investigation on the role of mechanical vibration on orthodontic tooth movement. J Biomech. 2017 Jul 26;60:57-64. doi: 10.1016/j.jbiomech.2017.06.012. Epub 2017 Jun 21.

    PMID: 28743370BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 29, 2020

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

July 1, 2017

Last Updated

December 29, 2020

Record last verified: 2020-12