The Effectiveness of Vibrational Applications on Orthodontic Treatment

NCT04206267 | Completed

• 1 other identifier: 709045004/134
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Control Group; Acceledent Group

Keywords

Tooth movement; AcceleDent; distalizing

Outcome Measures

Primary Outcomes (1)

• canine retraction rate

  İnitial 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 Outcomes (1)

• the compliance data on device use

  6 months

Study Arms (2)

Acceledent group

EXPERIMENTAL

Patients up to 18 years old who were planned first premolar extractions assigned to study group. AcceleDent Aura appliance was applied for 20 minutes per day. during canine retraction.

Device: Acceledent

Control group

NO INTERVENTION

Patients up to 18 years old who were planned first premolar extractions assigned to control group. The canine retractions were performed without any additional vibrational device.

Interventions

Acceledent DEVICE

Device for accelerating tooth movement

Acceledent group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• patients who were planned first premolar extractions
• demonstrated good oral hygiene

You may not qualify if:

• patients with poor oral hygiene and have periodontal problem

Sponsors & Collaborators

• Akdeniz University: lead

Related 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.

  PMID: 25758457 BACKGROUND

Study Officials

• Baris Telatar

  Akdeniz University Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: One investigator assigned the patients to study or control group and conducted the linear measurements with 3D Trios System, other investigator treated the samples
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Subjects were randomly allocated to either the AcceleDent group or the control group. The randomization was achieved by coin-tossing by one investigator. This method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = control group, Tails = AcceleDent group.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: March 15, 2016
• Primary Completion: August 15, 2016
• Study Completion: November 11, 2016
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share