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

A Clinical Trial on the Use of a Commercial Available Tooth Positioner for the Treatment of Simple Orthodontic Relapse

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.

Study Overview

• Status: Withdrawn
• Conditions: Orthodontics; Orthodontic Appliance
• Intervention / Treatment: Procedure: Tooth positioner

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tooth positioner treatment group; The participants that meet the inclusion criteria will be treated with tooth positioner.	Procedure: Tooth positioner; Orthodontic Tooth positioners treatment have been used in the Orthodontic Industry for many years. These positioners are used for small minor movements to complete the final smile. These positioners are made from a biocompatible and FDA approved clear silicone material after the teeth have been set to the final position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Little's Index	The Little's Index of Displacement score will be the primary clinical endpoint used to judge patient success (i.e., effectiveness).	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.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: IRB-300000946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No