Invisalign Wear Protocols for Orthodontic Treatment

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Orthognathic surgery, Extractions, Poor hygiene, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the Invisalign 3-day wear protocol treatment differ from other orthodontic treatments?

The Invisalign 3-day wear protocol is unique because it allows for faster aligner changes compared to traditional 7-day or longer protocols, potentially reducing overall treatment time. This approach is part of clear aligner therapy, which is known for being more comfortable and less visible than traditional braces. ^{1 2 3 4 5}

Research Team

Sarah Abu Arqub, DDS

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for healthy individuals aged 18-30 with moderate crowding of lower front teeth, needing Invisalign aligners. They must have good oral hygiene and no periodontal disease. People with previous orthognathic surgery, extraction treatment plans, poor oral hygiene, or craniofacial anomalies cannot participate.

Inclusion Criteria

I am between 18 and 30 years old.

I am physically healthy and have no significant allergies or medical issues.

Class I crowded dentition primarily for the lower anterior teeth (moderate crowding - 4-6 mm - according to Little's Irregularity Index)

Exclusion Criteria

I am undergoing or have undergone jaw surgery.

Patients with syndromes or craniofacial anomalies

The use of any other orthodontic appliance than clear aligners' (Invisalign)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Invisalign aligners with either a 3-day or 7-day wear protocol to assess orthodontic tooth movement

8 weeks

Regular visits for aligner fitting and monitoring

Extended Treatment

Continued treatment to assess occlusal outcomes and number of refinements needed

14 months

Periodic visits for assessment and adjustments

Follow-up

Participants are monitored for final outcomes and predictability of tooth movement

4 weeks

Treatment Details

Interventions

• Invisalign 3-day wear protocol
• Invisalign 7-day wear protocol

Trial Overview The study tests if a new 3-day wear protocol for Invisalign aligners can move teeth more predictably and quickly than the standard 7-day protocol by applying less movement per aligner to maintain constant force on the teeth.

Participant Groups

Group I: Group 2 (Experimental) Experimental Treatment 1 Intervention

Group II: Group 1 (Control) Active Control 1 Intervention

Invisalign 3-day wear protocol is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Invisalign for:

• Mild to moderate malocclusions
• Crowding
• Spacing
• Anterior crossbite

Approved in Canada as Invisalign for:

• Mild to moderate malocclusions
• Crowding
• Spacing
• Anterior crossbite

Approved in European Union as Invisalign for:

• Mild to moderate malocclusions
• Crowding
• Spacing
• Anterior crossbite

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Align Technology, Inc.

Industry Sponsor

Trials

10

Recruited

1,100+

Findings from Research

In a study involving 80 patients, the 7-day aligner change protocol resulted in treatment durations that were nearly half as long as the 14-day protocol (5 months vs 9 months), while achieving clinically similar accuracy in tooth movement outcomes.

Although the 14-day protocol showed greater accuracy in certain posterior movements, the differences were not clinically significant, suggesting that the 7-day protocol is an effective and time-efficient option for orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of clear aligner wear protocol on the efficacy of tooth movement. Al-Nadawi, M., Kravitz, ND., Hansa, I., et al.[2022]

In a study of 40 patients using the OrthoPulse® device alongside Invisalign® clear aligners, it was found that the device significantly reduced the need for additional finishing aligners, enhancing treatment predictability.

Patients using OrthoPulse® required only 66.5% of the initially planned aligners for finishing, compared to 103.4% in a control group, indicating that OrthoPulse® can improve the efficiency of orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictability of Invisalign® Clear Aligners Using OrthoPulse®: A Retrospective Study. Levrini, L., Carganico, A., Deppieri, A., et al.[2022]

The use of a high frequency acceleration device (HFA) during aligner orthodontic treatment significantly reduced treatment time and the number of aligners needed, with subjects using HFA exchanging aligners every five days compared to every 14 days for controls.

None of the subjects using the HFA required refinements in their treatment, while six out of eight control subjects needed one or more refinements, indicating that HFA may enhance the effectiveness of aligner therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High Frequency Acceleration Device on Aligner Treatment-A Pilot Study. Shipley, TS.[2020]

A survey of 172 orthodontists revealed that removable appliances are commonly prescribed for active orthodontic treatment, with Schwartz plates used in 43.7% and functional orthopedic appliances in 37.6% of cases.

Most orthodontists (60%) specify particular times for wear, with average prescribed wear times of 15 hours for functional appliances and 16 hours for plates, which aligns with the minimum necessary wear times for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recommended times for wearing removable appliances--the results of a survey]. Witt, E., Bartsch, A., Sahm, G.[2019]

Teenage patients who were aware that their retainer usage was being monitored wore their retainers significantly more hours per day compared to those who were unaware of the monitoring, highlighting the importance of awareness in improving compliance.

Patients who reported full usage of their retainers actually wore them an average of 4.3 hours more per day than those who did not, and those who misrepresented their usage wore the retainers 12.4 hours less than honest patients, indicating a gap between reported and actual compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttreatment compliance with removable maxillary retention in a teenage population: a short-term randomized clinical trial. Ackerman, MB., Thornton, B.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of clear aligner wear protocol on the efficacy of tooth movement. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Predictability of Invisalign® Clear Aligners Using OrthoPulse®: A Retrospective Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of High Frequency Acceleration Device on Aligner Treatment-A Pilot Study. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Recommended times for wearing removable appliances--the results of a survey]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Posttreatment compliance with removable maxillary retention in a teenage population: a short-term randomized clinical trial. [2015]