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Intermittent Vibrational Force and Orthodontic Tooth Movement

NCT ID: NCT02314975

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Crowding Vibrational Force Fixed Orthodontic Appliances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AcceleDent vibrational device

Fixed appliances with supplementary vibrational force

Group Type EXPERIMENTAL

AcceleDent vibrational device

Intervention Type DEVICE

Supplementary vibrational force with fixed appliances

Sham AcceleDent device

Fixed appliances with supplementary sham device

Group Type SHAM_COMPARATOR

Sham AcceleDent device

Intervention Type DEVICE

Supplementary sham-vibrational device with fixed appliances

Fixed appliance only

Fixed appliances only

Group Type ACTIVE_COMPARATOR

Fixed appliance only

Intervention Type OTHER

Fixed appliance treatment only

Interventions

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AcceleDent vibrational device

Supplementary vibrational force with fixed appliances

Intervention Type DEVICE

Sham AcceleDent device

Supplementary sham-vibrational device with fixed appliances

Intervention Type DEVICE

Fixed appliance only

Fixed appliance treatment only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* no medical contraindications; no craniofacial anomalies or cleft lip/palate;
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 29602338 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27894540 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25758457 (View on PubMed)

Other Identifiers

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11/LO/0056

Identifier Type: -

Identifier Source: org_study_id