The Effectiveness of Vibrational Applications on Orthodontic Treatment

Control Group Clinical Trial

Official title:

The Effectiveness of Vibrational Applications On Orthodontic Treatment: A Randomized-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206267
• Other study ID #: 709045004/134
• Status: Completed
• Phase: N/A
• Start date: March 15, 2016
• Est. completion date: November 11, 2016

Study information

• Verified date: June 2020
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether vibrational applications, as an adjunct to orthodontic forces, increases the rate of tooth movement in patients with fixed orthodontic appliances.

Description:

Nineteen patients who had class 2 division 1 malocclusion or severe crowding and needed first premolar extractions as a treatment modality were included to the study. The patients were divided into two groups, 8 in control and 11 in the study. The subjects assigned to study group were applied suplementary vibrational forces for 20 min/daily. 3-dimensional digital models were generated just before canine distalization and after space closure by 3Shape TRİOS R700 (3Shape Inc., Copenhagen, Denmark) device. The linear measurements between molars and canines were evaluated. The results were assessed with SPSS 23.0 programme (lBM SPSS Statistics for Windows, NY, USA). The amount of tooth movement for all samples were measured twice by the responsible investigator at one week interval. Interclass correlation coefficient-ICC was used to asses intraobserver accuracy and reliability.Mann- Whitney U test was used to assess treatment effect in terms of time to reach canine distalization. Correlation between measurements were described with Spearman Correlation Coefficient. Interclass correlation was 95%, which is in the range of excellent measurement agreement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 11, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• patients who were planned first premolar extractions

• demonstrated good oral hygiene

Exclusion Criteria:

• patients with poor oral hygiene and have periodontal problem

Related Conditions & MeSH terms

• Acceledent Group
• Control Group

Intervention

Device:
• Acceledent
Device for accelerating tooth movement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	canine retraction rate	Initial measurements were conducted after levelling stage and prior to retraction of the canine tooth. Linear measurements were performed between mesial edges of molar tubes and distal edges of canine brackets. Due to using TADs as direct anchorage it is considered that the molars remained constant during the retraction process. After retraction stage, measurements were performed between the mesial edges of the molar tubes and the distal edges of the canine brackets, and the monthly tooth movement rates were detected according to the difference between initial and second measurements.	6 months
Secondary	the compliance data on device use	it was collected by downloading the tracking information on the device	6 months