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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether changing the frequency of switching Invisalign aligners improves teeth straightening results. Specifically, it compares the current 7-day wear protocol to a new 3-day wear protocol to determine if it makes teeth move more predictably and effectively. The trial seeks participants with moderate crowding in their lower front teeth who are generally healthy and maintain good oral hygiene. Participants must use Invisalign aligners and not require other orthodontic devices or surgeries. As an unphased trial, this study offers a unique opportunity to contribute to innovative orthodontic research that could enhance future treatment options.

Will I have to stop taking my current medications?

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

What prior data suggests that these Invisalign wear protocols are safe for orthodontic treatment?

Research has shown that Invisalign aligners, whether worn for 3 days or 7 days at a time, are generally safe and well-tolerated. Studies have found that clear aligners offer a convenient and effective way to straighten teeth. However, some concerns exist about the materials used. For instance, the plastic may release a small amount of chemicals, but overall, aligners are considered safe.

For the 7-day wear schedule, some reports suggest that wearing aligners for longer periods might affect gum health, possibly leading to issues like gum inflammation (gingivitis). Despite this, many people complete their treatment without major problems.

In summary, both the 3-day and 7-day schedules are widely used and generally safe, with only minor concerns about gum health and the materials used. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Invisalign wear protocols because they aim to find out if shorter wear times can be just as effective as traditional methods. Traditional Invisalign treatments usually require wearing aligners for 7 to 14 days before switching to the next set, but this trial is exploring a faster 3-day wear protocol. If the 3-day protocol proves effective, it could significantly speed up orthodontic treatment, offering quicker results for patients. This could mean less time in treatment and more convenience for those looking to improve their smiles.

What evidence suggests that the Invisalign wear protocols could be effective for orthodontic treatment?

Research shows that Invisalign aligners effectively straighten teeth when used as directed. Studies indicate that Invisalign can achieve over 90% success if patients follow their dentist's advice. In this trial, participants will follow different schedules for wearing the aligners: the 3-day wear protocol or the 7-day wear protocol. Research finds both 3-day and 7-day plans effective. However, wearing them for 3 days at a time might make tooth movement more predictable and faster. Both schedules control tooth position well and lead to satisfying results. Overall, Invisalign is a dependable choice for orthodontic treatment when used properly. ^{4 6 7 8 9}

Who Is on the Research Team?

Sarah Abu Arqub, DDS

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 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)

Any ethnic group

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8028485/

Effect of clear aligner wear protocol on the efficacy of tooth ... To compare the efficacy of orthodontic tooth movement with three aligner wear protocols: 7 day, 10 day, and 14 day.

2. fallspointedentistry.com fallspointedentistry.com/does-invisalign-really-work-unpacking-the-clear-aligner-success-rate/

Does Invisalign Really Work? Truth About Clear Aligners Clinical studies and patient outcomes have shown that Invisalign can achieve success rates exceeding 90% when patients follow their dentist's ...

3. nature.com nature.com/articles/s41598-025-86345-9

The effectiveness of orthodontic treatment with clear ... This study aimed to evaluate the effectiveness, pain, and satisfaction levels of patients treated with different thicknesses of clear aligners.

4. aligntech.com aligntech.com/about/clinical_evidence

The science behind the Invisalign® smile The Invisalign® aligner group showed a statistically significant intrusion of the mandibular incisors, with excellent control in the proclination of incisors ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1073874625000350

Clear aligner therapy and its effectiveness in the ... This article aims to highlight the current literature on clear aligner therapy's (CAT) effectiveness in achieving these objectives.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8871989/

Cleaning and Disinfection Protocols for Clear Orthodontic ... Each participant had to perform 3 different cleaning/disinfection protocols for their aligners successively: - 15 s rinsing under tap water ( ...

7. invisalign.com invisalign.com/frequently-asked-questions

Invisalign® Aligners FAQs | Dental Questions Have questions about Invisalign® treatment? Find answers on our FAQ page about aligners, treatment time, and its process.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10597356/

Clear Aligner Therapy: Up to date review article - PMC Clear Aligner Therapy is a safe, effective, and convenient orthodontic treatment option that offers patients a virtually invisible way to achieve a straighter, ...

9. mdpi.com mdpi.com/2079-4983/16/5/173

Do Clear Aligners Release Toxic Chemicals? Our results suggest that clear aligners are generally safe, but concerns remain regarding the chemical leaching of thermoplastic materials.