Clinical trial NCT04260633: Optimizing Aligner Wear Time and Change Frequency
Official title: Optimizing Aligner Wear Time and Change Frequency: A Single-Blind, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adjunctive Usage of Vibrational Therapy
Dental Monitoring Accuracy
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a prospective, randomized, controlled, single-blind, parallel group clinical trial.
Primary purpose: TREATMENT

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.


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:

Inclusion:

* 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:

* 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
* Subjects who present with class I malocclusions but have severe crowding (\> 7 mm) that requires extraction, \>4 mm positive overjet and \> 2 mm negative overjet, extreme deep bite ( \> 90%), severe open bite (\>2 mm)
* Women who are pregnant
* Patients that smoke
* Patients with active caries
* Patients that require interproximal reduction or attachments in the remaining prescription
* Patients who have temporary anchorage devices in place
* Patients who have vertigo or issues with their temporomandibular joint
* Patients with less than 3 mo. remaining in aligner treatment
* Patients who have documented bruxism

Primary outcomes:
measure: Time to complete 10 trays to determine the average aligner change frequency measured at the completion of the study
timeFrame: 70-140 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: