IFPE (Invisalign First Palatal Expander)

NCT06230484 | Not Yet Recruiting FDA Device

• 1 other identifier: H23-00231
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Malocclusions with narrow upper arches are usually treated in the mixed dentition with a traditional bonded maxillary expander. Most recently, a new design of a removable expander by Align was brought to our attention. In this prospective clinical study, the investigators will compare the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions. With this study, the investigators will have a better understanding of this newly developed appliance and its application in early orthodontic treatment.

Conditions

Narrow Maxilla

Outcome Measures

Primary Outcomes (7)

• inter-canine, inter-molar, and palatal width

  measured by using Rhino3D v5.0 software in millimeters

  one year

• Qualitative measurements from questionnaire- level of pain and discomfort

  VAS = visual analogue scale, ranges from minimum score 0% (extremely uncomfortable) to 100% (very comfortable). Higher score is good (comfortable).

  one year

• molar inclination

  measured by using Rhino3D v5.0 software in degrees

  one year

• surface area

  measured by using Rhino3D v5.0 software in millimeters squared

  one year

• volume

  measured by using Rhino3D v5.0 software in millimeters cubed

  one year

• noncavitated carious lesions

  The buccal surfaces of the maxillary molars will be assessed for noncavitated carious lesions (white spot lesions) using the International Caries Detection and Assessment System (ICDAS) index. The higher the score the worse condition: 0 Sound 1. First visual change in enamel (seen only after prolonged air drying or restricted to the confines of a pit or fissure) 2. Distinct visual change in enamel 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) 4. Underlying dark shadow from dentin 5. Distinct cavity with visible dentin 6. Extensive distinct cavity with visible dentin

  one year

• Plaque

  Plaque index was assessed using color-based plaque staining. 0 - no visible plaque, 1-plaque visible only by scraping on the denture base with a blunt instrument, 2-moderate accumulation of visible plaque, and 3-abundance of plaque. By summing up the scores from the five areas, the plaque was recorded on a scale from 0 to 15 points.

  one year

Study Arms (2)

IFPE patients

ACTIVE COMPARATOR

patients receiving IFPE treatment

Device: Invisalign first palatal expander

(control group): RME patients

ACTIVE COMPARATOR

patients receiving conventional rapid maxillary expansion treatment

Device: Conventional rapid maxillary expansion

Interventions

Invisalign first palatal expander DEVICE

Most recently, a new design of a removable expander by Align was brought to our attention. In this prospective clinical study, the investigators will compare the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions. With this study, the investigators will have a better understanding of this newly developed appliance and its application in early orthodontic treatment.

IFPE patients

Conventional rapid maxillary expansion DEVICE

Malocclusions with narrow upper arches are usually treated in the mixed dentition with a traditional bonded maxillary expander.

(control group): RME patients

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients in mixed dentition with 6 present on both Right and Left in the upper arch
• Patients with transverse maxillary deficiency (presence of unilateral or bilateral crossbite, or intermolar width (as measured where the palatal groove meets the gingival margin of the first molar) of 33 mm or less)

You may not qualify if:

• multiple and/or advanced caries,
• missing teeth due to aplasia, trauma, or deep caries,
• supernumerary teeth,
• congenital craniofacial malformations or congenital or acquired systematic disease,
• previous orthodontic treatment

Sponsors & Collaborators

• University of British Columbia: lead

Central Study Contacts

Mirian Dang, DDS

CONTACT

6048222112; drzou@dentistry.ubc.ca

Bingshuang Zou, DDS

CONTACT

drzou@dentistry.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share