Invisalign Expander for Palate Expansion

Overseen By Heeyeon Suh

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of the Pacific

Disqualifiers: General health problems, Craniofacial anomalies, Skeletal Class III, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12-18 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the Invisalign Palatal Expander system against a traditional expander in promoting upper jaw growth in young patients. It targets those with dental issues such as a crossbite or a narrow upper jaw. Participants should have a mix of adult and baby teeth and no major dental work on specific molars. The goal is to determine if this new system performs as well as or better than the usual treatment. As an unphased trial, it allows participants to contribute to innovative dental solutions that could benefit future patients.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the Invisalign Palatal Expander System is safe for palate expansion?

Research has shown that the Invisalign Palatal Expander System is safe and effective for widening the upper jaw in children. The FDA has approved this treatment, indicating it has passed safety checks for this specific use. The system's removable design offers convenience for patients.

Studies have found that this expander works well without causing major side effects. Reports of unexpected health problems remain rare, suggesting it is well-tolerated by patients. Overall, the evidence supports its safety in aiding jaw expansion for young patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Invisalign Palatal Expander System because it offers a less invasive and more aesthetically pleasing alternative to traditional palate expanders, like the Hyrax-type maxillary expander. Unlike the standard metal devices, the Invisalign system uses clear aligner technology, which is more comfortable for patients and nearly invisible when worn. This system also allows for greater precision and customization in adjusting the palate, potentially leading to more efficient treatment outcomes.

What evidence suggests that the Invisalign Palatal Expander System is effective for palate expansion?

Research has shown that the Invisalign Palatal Expander System, one of the treatments studied in this trial, effectively widens the upper jaw in growing children. Studies have found that it successfully expands the midline of the palate, helping to make the upper jaw wider. This system offers a less invasive option compared to traditional expanders like the Hyrax-type, which is another treatment arm in this trial and uses metal parts and screws. Early results suggest that Invisalign can be a safer and effective choice for expanding the dental arch, especially when the upper jaw is narrow. Overall, the Invisalign Palatal Expander System promises jaw expansion without the discomfort of traditional methods. ^{2 5 6 7 8}

Who Is on the Research Team?

Heeyeon Suh

Principal Investigator

University of the Pacific

Are You a Good Fit for This Trial?

This trial is for patients with a narrow upper jaw presenting as unilateral or bilateral posterior crossbite, who are in the mixed or early permanent dentition phase without fully erupted second molars. Participants must have stable teeth and be willing to consent. Those with craniofacial anomalies, Class III skeletal profile, or significant health issues affecting treatment are excluded.

Inclusion Criteria

Unilateral or bilateral posterior cross bite patients

Subjects willing to consent to the trial

Patients with Class I or Class II skeletal relationship

Exclusion Criteria

Any craniofacial anomalies

Skeletal Class III patients

I have health issues that could affect my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Invisalign Palatal Expander System or the Hyrax-type maxillary expander

12-18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Invisalign Palatal Expander System

Trial Overview The study evaluates the Invisalign Palatal Expander system's effectiveness in growing patients compared to conventional palatal expansion techniques. It's a randomized controlled trial which means participants will be randomly assigned to receive either the new Invisalign system or standard treatment.

How Is the Trial Designed?

Group I: Invisalign® Palatal Expander System Experimental Treatment 1 Intervention

Invisalign® Palatal Expander System will be delivered.

Group II: Hyrax-type maxillary expander Active Control 1 Intervention

Hyrax-type maxillary expander will be delivered. The Hyrax-type maxillary expander will include a midline self-locking screw, which is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician

Invisalign Palatal Expander System is already approved in European Union for the following indications:

Approved in European Union as Invisalign Palatal Expander System for:

• Skeletal and dental expansion in growing patients
• Orthodontic treatment of malocclusion

Who Is Running the Clinical Trial?

University of the Pacific

Lead Sponsor

Trials

16

Recruited

1,000+

Published Research Related to This Trial

Palatal expansion is easier and more effective in children and adolescents, but becomes more complex after growth is complete, necessitating advanced techniques like surgically assisted rapid palatal expansion.

A customized bone-borne expansion device was used in a clinical case, providing improved predictability and stability through multiple support points, which may lead to better long-term results in maxillary compression correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically assisted rapid palatal expansion using customized bone-borne devices. Bilbao, A., Pérez-Varela, JC., Pérez-López, D., et al.[2020]

The acrylic TAD-supported palate lateral wall expander is a reliable and cost-effective option for treating transverse malocclusions in adolescents and young adults (ages 13 to 21), offering both nonsurgical and surgically assisted expansion options.

This type of expander can help prevent more complex dental issues in the future, making it a versatile tool in orthodontic treatment for maxillary transverse deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtually Guided Palate Lateral Wall, TAD-Supported Expansion in Craniofacial Skeletally Mature Adolescents and Young Adults. Hirschhaut, M., Leon, N., Pereira, A., et al.[2023]

Rapid palatal expansion using an appliance can lead to complications, such as necrosis of the palatal gingiva, highlighting the need for careful monitoring during the procedure.

This case emphasizes the importance of caution in pediatric dentistry, as palatal expansion is commonly performed on younger patients, and adverse effects can have significant implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gingival necrosis in relation to palatal expansion appliance: an unwanted sequelae. Sardessai, G., Fernandesh, AS.[2019]

The placement of rapid palatal expanders (RPEs) initially caused a deterioration in speech acceptability among 22 patients, but their speech improved over time and returned to baseline levels after the RPEs were removed.

Acoustic analysis showed that vowel and fricative sounds were distorted when the RPEs were first placed, but these distortions normalized after the appliances were taken out, indicating that while RPEs affect speech temporarily, patients can adapt over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a rapid palatal expander on speech articulation. Stevens, K., Bressmann, T., Gong, SG., et al.[2011]

A new rigid palatal distractor device was developed for maxillary expansion, which effectively corrects cross-bites and improves dental occlusion without complications, based on reported cases.

This device offers significant advantages over traditional palatal distractors, including better bodily maxillary movement, reduced risk of relapse, and a straightforward anchorage method that accommodates orthodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New palatal distraction device by both bone-borne and tooth-borne force application in a paramedian bone anchorage site: surgical and occlusal considerations on clinical cases. Cortese, A., Savastano, G., Amato, M., et al.[2018]

The study evaluated 167 patients treated with Invisalign® and found that the system is effective for orthodontic expansion, with a statistically significant difference in efficacy between upper and lower arches (p<0.00005).

In terms of predictability, the Invisalign® system achieved 98-100% accuracy at the coronal level and 85-90% at the gingival level, with moderate expansions being the most predictable, especially in the lower arch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and predictability of maxillary and mandibular expansion with the Invisalign® system. Vidal-Bernárdez, ML., Vilches-Arenas, Á., Sonnemberg, B., et al.[2022]

Invisalign First System (IFS) significantly increased intercanine width (ICW) by 3.10 mm and intermolar width (IMW) by 1.95 mm in 23 mixed dentition patients, but these increases were smaller compared to those achieved with slow maxillary expansion (SME).

IFS did not significantly affect palatal dimensions or molar inclinations, showing that while it can expand the upper arch, it does so less effectively than SME and does not alter molar positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dimensional changes in the palate associated with Invisalign First System: a pilot study. Wang, J., Bukhari, A., Tai, SK., et al.[2023]

In a study involving 40 patients (20 with permanent molars and 20 with deciduous molars), a digitally designed palatal expander showed that using second deciduous molars resulted in less dental torque augmentation compared to using first permanent molars.

Both groups experienced significant changes in the transverse diameter of the palate over time, but there were no significant differences between the two groups in terms of these modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Torque changes of anchorage units in preadolescent patients treated with a digitally designed tooth-borne expander anchored to deciduous vs. permanent molars. Drago, S., Campobasso, A., Battista, G., et al.[2023]

In a study of 36 subjects aged around 12 years, the computer-guided miniscrew-supported rapid palatal expansion appliance resulted in a greater and statistically significant increase in transversal skeletal width compared to the traditional tooth-borne hyrax appliance.

The tooth-borne expander caused more buccal inclination of the maxillary first molars and greater dentoalveolar transverse diameters, indicating that the skeletal expander minimizes unwanted dental side effects while effectively expanding the nasal-maxillary structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of changes in skeletal, dentoalveolar, periodontal, and nasal structures after tooth-borne or bone-borne rapid maxillary expansion: A parallel cohort study. Altieri, F., Cassetta, M.[2022]

A study involving 24 patients, divided into two age groups (≤16 years and >16 years), demonstrated that a bone-borne palatal expander effectively widened the maxilla in both growing and young adult patients.

There were no significant differences in skeletal or dental changes between the two age groups, indicating that this treatment is equally effective regardless of age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skeletal and dental changes after maxillary expansion with a bone-borne appliance in young and late adolescent patients. Annarumma, F., Posadino, M., De Mari, A., et al.[2021]

Most patients experienced initial discomfort, speech issues, and chewing difficulties after receiving palatal expanders, but these problems typically resolved within the first week.

The type of expander used and the age of the patients did not significantly affect the level of discomfort or adaptation, suggesting that discomfort should not be the primary factor in choosing an appliance for palatal expansion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of palatal expanders on oral comfort, speech, and mastication. De Felippe, NL., Da Silveira, AC., Viana, G., et al.[2015]

Citations

1. ajodo.org ajodo.org/article/S0889-5406(24)00144-6/fulltext

Efficacy of clear aligners vs rapid palatal expanders on ... This study aimed to evaluate the efficacy of Invisalign First Phase I treatment compared with tooth-borne rapid maxillary expansion (RME) in mixed dentition ...

2. invisalign.com invisalign.com/provider/invisalign-solutions/for-orthodontists/for-kids/invisalign-palatal-expander

Invisalign Palatal Expander System Safe and clinically effective treatment ... Invisalign Palatal Expander treatment delivers on your clinical goals to achieve mid-palatine suture expansion 3.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06662279

Hyrax Vs. Invisalign Palatal Expander Clinical Study A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

4. investor.aligntech.com investor.aligntech.com/news-releases/news-release-details/invisalignr-palatal-expander-system-align-technology-now-4

Invisalign® Palatal Expander System by ... Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10463527/

Treatment effects after maxillary expansion using invisalign ... RME shows significant better efficiency of dental arch expansion than First, recommended for patients with severe MTD. Trial registration. This ...

6. invisalign.com invisalign.com/palatal-expander

Invisalign® Palatal Expander Clinically proven to be safe and effective. The Invisalign Palatal Expander System is the only FDA-cleared, removable palatal expander that's just as effective ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232887.pdf

K232887 - Sindhura Gaddamanugu - accessdata.fda.gov The Invisalign Palatal Expander System is for orthodontic treatment of malocclusion, used for rapid expansion of the upper jaw in children and ...

8. investor.aligntech.com investor.aligntech.com/news-releases/news-release-details/invisalignr-palatal-expander-system-align-technology-now-1

Invisalign® Palatal Expander System by ... Invisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.