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

NCT ID: NCT03332082

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Orthodontics; Orthodontic Appliance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tooth positioner treatment group

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

Group Type: EXPERIMENTAL

Tooth positioner

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Chung How Kau

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB-300000946

Identifier Type: -

Identifier Source: org_study_id