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

Orthodontics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03332082
• Other study ID #: IRB-300000946
• Status: Withdrawn
• Phase: N/A
• Start date: January 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance
• Orthodontics

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.