A Commercial Available Tooth Positioner for the Treatment of Simple Orthodontic Relapse

Not Applicable

Withdrawn

• Conditions: Orthodontics; Orthodontic Appliance
• Interventions: Procedure: Tooth positioner

• Registration Number: NCT03332082
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Orthodontic relapse occurs in almost 80% of Orthodontic Treatment. The only prevention to phenomenon is the use of fixed retainers or life time active retention. Unfortunately, patients do not comply and after a year of treatment, many stop wearing their retainers and Orthodontic relapse occurs.

The aim of this project is to prospectively analyze the treatment result of consecutive treated patients who have had active orthodontic relapse. 20 patients will be recruited through advertisement to the Department of Orthodontics at the University of Alabama at Birmingham (UAB). The sample will comprise of 20 patients with Class I malocclusions. The records to be collected will comprise of clinical pictures and pre and post study casts. The 3D study casts will be evaluated using the Little's Index. The results will be analyzed with the paired t-test and ANOVA, using the Statistical Analysis System (SAS/STAT®) software.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Permanent dentition
2. Class I malocclusion with crowding or spacing of less than 6 mm for mandibular or maxillary incisors, lower number 1's through 3's
3. Predicted compliance with device use, as determined by the investigator orthodontist
4. Good oral hygiene, as determined by the investigator orthodontist
5. At least average intelligence, as determined by investigator orthodontist

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Exclusion Criteria

1. Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study
2. Patient is currently using any investigational drug or any other investigational device
3. Patient plans to relocate or move within six months of enrollment
4. Allergic to acetaminophen (use of aspirin or non-steroidal anti-inflammatory drugs is excluded for patients while on the study)
5. Use of bisphosphonates, such as osteoporosis drugs, during the study
6. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tooth positioner treatment group	Tooth positioner	The participants that meet the inclusion criteria will be treated with tooth positioner.

Primary Outcome Measures

Name	Time	Method
The Little's Index	Movement will be recorded by capturing the start and end point of the 6 anterior teeth before and at the completion of the treatment respectively. The duration of the treatment will be up to 10 months.	The Little's Index of Displacement score will be the primary clinical endpoint used to judge patient success (i.e., effectiveness).