NCT02314975

Brief Summary

The aim of this study is to compare the clinical efficiency of conventional fixed appliance orthodontic treatment with that supplemented by the daily application of cyclic forces to the dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root length.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-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

June 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

3.4 years

First QC Date

November 25, 2014

Last Update Submit

December 9, 2014

Conditions

Dental CrowdingVibrational ForceFixed Orthodontic Appliances

Outcome Measures

Primary Outcomes (1)

  • Orthodontic tooth movement (incisor alignment)

    Irregularity (crowding) of the mandibular (lower) dental arch will be measured as total contact point displacement between the six canine and incisor teeth using digital calipers (150mm ISO 9001 electronic calliper, Tesa Technology, Renens, Switzerland; resolution ± 0.01mm) from stone dental casts. Initial crowding will be measured at T1 prior to the start of treatment. Irregularity will then be measured at T2 (at first archwire change) and the initial rate of orthodontic tooth movement calculated. Irregularity will then be measured at T3 (final alignment of the teeth) to calculate overall rate of alignment.

    2-12 months from start

Secondary Outcomes (3)

  • Discomfort during initial orthodontic tooth movement

    1 week from start

  • Orthodontic space closure

    6-30 months from start

  • Root resorption

    6-12 months from start

Study Arms (3)

AcceleDent vibrational device

EXPERIMENTAL

Fixed appliances with supplementary vibrational force

Device: AcceleDent vibrational device

Sham AcceleDent device

SHAM COMPARATOR

Fixed appliances with supplementary sham device

Device: Sham AcceleDent device

Fixed appliance only

ACTIVE COMPARATOR

Fixed appliances only

Other: Fixed appliance only

Interventions

AcceleDent vibrational deviceDEVICE

Supplementary vibrational force with fixed appliances

AcceleDent vibrational device
Sham AcceleDent deviceDEVICE

Supplementary sham-vibrational device with fixed appliances

Sham AcceleDent device
Fixed appliance onlyOTHER

Fixed appliance treatment only

Fixed appliance only

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects will be recruited from a sample of consecutive cases attending for routine fixed appliance orthodontic treatment with conventional pre-adjusted edgewise brackets that satisfy the following criteria: in the permanent dentition; a requirement for extraction of a premolar unit in each quadrant; incisor irregularity between 5-12 mm.

You may not qualify if:

  • no medical contraindications; no craniofacial anomalies or cleft lip/palate;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 29602338DERIVED

  • DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Cobourne MT. Effect of supplemental vibrational force on orthodontically induced inflammatory root resorption: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):918-927. doi: 10.1016/j.ajodo.2016.06.025.

    PMID: 27894540DERIVED

  • Woodhouse NR, DiBiase AT, Johnson N, Slipper C, Grant J, Alsaleh M, Donaldson AN, Cobourne MT. Supplemental vibrational force during orthodontic alignment: a randomized trial. J Dent Res. 2015 May;94(5):682-9. doi: 10.1177/0022034515576195. Epub 2015 Mar 10.

    PMID: 25758457DERIVED

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 11, 2014

Study Start

June 1, 2011

Primary Completion

November 1, 2014

Last Updated

December 11, 2014

Record last verified: 2014-12