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

Primary Purpose

Orthodontics, Orthodontic Appliance

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Tooth positioner

About this trial

This is an interventional treatment trial for Orthodontics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tooth positioner treatment group

Arm Description

The participants that meet the inclusion criteria will be treated with tooth positioner.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03332082

First Posted

October 26, 2017

Last Updated

March 25, 2019

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03332082

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Withdrawn

Why Stopped

losing of funding for the study

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthodontics, Orthodontic Appliance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

20 patients will be recruited and treated with a commercially available tooth positioner. The results will be compared with the other group from previously treated patients who were in the alignment phase of Orthodontics.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tooth positioner treatment group

Arm Type

Experimental

Arm Description

The participants that meet the inclusion criteria will be treated with tooth positioner.

Intervention Type

Procedure

Intervention Name(s)

Tooth positioner

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Little's Index

Description

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

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Permanent dentition Class I malocclusion with crowding or spacing of less than 6 mm for mandibular or maxillary incisors, lower number 1's through 3's Predicted compliance with device use, as determined by the investigator orthodontist Good oral hygiene, as determined by the investigator orthodontist At least average intelligence, as determined by investigator orthodontist Exclusion Criteria: Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study Patient is currently using any investigational drug or any other investigational device Patient plans to relocate or move within six months of enrollment Allergic to acetaminophen (use of aspirin or non-steroidal anti-inflammatory drugs is excluded for patients while on the study) Use of bisphosphonates, such as osteoporosis drugs, during the study Pregnancy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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