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

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.

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 data supports the effectiveness of the Invisalign Palatal Expander System treatment?

Research shows that the Invisalign system can effectively expand the upper and lower jaw, similar to other orthodontic expansion methods, which suggests it may also be effective for palate expansion. ^{1 2 3 4 5}

Is the Invisalign Expander for Palate Expansion safe for humans?

The research on palatal expanders, including those similar to the Invisalign Expander, suggests that they generally result in successful expansion without significant problems or complications. However, some studies mention potential discomfort, speech impairment, and chewing difficulty during initial adaptation. ^{1 2 5 6 7}

How is the Invisalign Palatal Expander System treatment different from other palate expansion treatments?

The Invisalign Palatal Expander System is unique because it likely offers a more discreet and comfortable option for palate expansion compared to traditional expanders, which can affect speech and require attachments cemented to the teeth. This system may use clear aligner technology, similar to other Invisalign products, providing a less invasive and more aesthetically pleasing alternative. ^{1 8 9 10 11}

Research Team

Heeyeon Suh

Principal Investigator

University of the Pacific

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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 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]

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 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]

References

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

Dimensional changes in the palate associated with Invisalign First System: a pilot study. [2023]

2. United States 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. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Surgically assisted rapid palatal expansion using customized bone-borne devices. [2020]

4. Spain pubmed.ncbi.nlm.nih.gov

Efficacy and predictability of maxillary and mandibular expansion with the Invisalign® system. [2022]

5. Italy 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. [2023]

6. United States 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. [2018]

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

Influence of palatal expanders on oral comfort, speech, and mastication. [2015]

8. Singapore pubmed.ncbi.nlm.nih.gov

Gingival necrosis in relation to palatal expansion appliance: an unwanted sequelae. [2019]

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

Virtually Guided Palate Lateral Wall, TAD-Supported Expansion in Craniofacial Skeletally Mature Adolescents and Young Adults. [2023]

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

Impact of a rapid palatal expander on speech articulation. [2011]

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

Skeletal and dental changes after maxillary expansion with a bone-borne appliance in young and late adolescent patients. [2021]