The Effectiveness of Vibrational Applications On Orthodontic Treatment: A Randomized-Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Akdeniz University
- Enrollment
- 19
- Primary Endpoint
- canine retraction rate
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
One investigator assigned the patients to study or control group and conducted the linear measurements with 3D Trios System, other investigator treated the samples
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients who were planned first premolar extractions
- •demonstrated good oral hygiene
Exclusion Criteria
- •patients with poor oral hygiene and have periodontal problem
Arms & Interventions
Acceledent group
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.
Intervention: Acceledent (Device)
Control group
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.
Outcomes
Primary Outcomes
canine retraction rate
Time Frame: 6 months
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.
Secondary Outcomes
- the compliance data on device use(6 months)
Investigators
Baris Can Telatar
Principal investigator
Akdeniz University