Optimizing Aligner Wear Time and Change Frequency: A Single-Blind, Randomized Control Trial

Harvard School of Dental Medicine0 sites85 target enrollmentMarch 1, 2020

ConditionsAdjunctive Usage of Vibrational Therapy Dental Monitoring Accuracy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adjunctive Usage of Vibrational Therapy
Sponsor: Harvard School of Dental Medicine
Enrollment: 85
Primary Endpoint: Time to complete 10 trays to determine the average aligner change frequency measured at the completion of the study
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study aims to help improve individualization and optimization of clear aligner therapy through the use of new technologies in orthodontics. The study will compare 12-hour and 22-hour tray wear time and evaluate the adjunctive use of Vpro+. The study clinicians will use Dental Monitoring to monitor study participants throughout the trial and will use the Dental Monitoring system to instruct patients to continue or stay on their clear aligners. The outcome of the study will be the time it takes to complete 10 trays.

Registry

clinicaltrials.gov

Start Date

March 1, 2020

End Date

March 1, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Harvard School of Dental Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
•Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
•Periodontal probing depths (PD) \< 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
•Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
•Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
•Participants must be able to master the use of the Dental Monitoring Application

Exclusion Criteria

•Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
•Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
•Periodontal probing depths (PD) \< 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
•Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
•Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
•Participants must be able to master the use of the Dental Monitoring Application
•Subjects who have within the last 6 mo taken any antibiotic medications or have had any periodontal treatments
•Subjects who have taken/are taking medications that affect bone remodeling: anti-resorptive medications, medications that may affect hormone levels, thyroid replacement medications, corticosteroids, and daily nonsteroidal anti-inflammatory medications
•Subjects who have had chemotherapy or radiation therapy in the last 6 mo
•Subjects who present with severe class II/III malocclusions