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The goal of this clinical trial is to compare two types of palatal expanders used with a facemask in children who have skeletal Class III and a narrow upper jaw. The study will compare the Invisalign Palatal Expander (IPE) and the Rapid Palatal Expander (RPE). Researchers want to learn how these devices affect jaw bones and tooth position. They also want to learn about children's and parents' experiences during treatment.
The main questions this study aims to answer are:
Do IPE and RPE widen the upper jaw differently?
Do they cause different changes in tooth position?
How do children and parents describe their treatment experience?
Participants will be children aged 8 to 12 years who have skeletal Class III and a narrow upper jaw. Children with craniofacial conditions, previous upper jaw expansion, or medical conditions that prevent orthodontic treatment will not take part. Parents and children must give consent before joining the study.
Participants will:
Be assigned to receive either IPE or RPE
Expand the upper jaw to 7 mm (0.25 mm per day)
After expansion, wear a facemask for at least 12 hours per day for 6 to 8 months
Have cone-beam computed tomography (CBCT) scans taken before expansion, after expansion, and after facemask treatment
Take part in an interview with a parent after expansion
Researchers will use CBCT images to measure changes in jaw bones and tooth position. The main outcomes are changes in jaw bones and tooth position. Secondary outcomes include children's and parents' experiences during treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invisalign Palatal Expander (IPE) group | Experimental |
| |
| Rapid Palatal Expander (RPE) group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invisalign Palatal Expander (IPE) | Device | Participants will be treated with an Invisalign palatal expander. Participants will be instructed to wear the appliance full-time, except when brushing and flossing their teeth, and to change the device daily (0.25 mm) until the planned transverse width (7 mm.) is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Maxillary skeletal change |
| T0: Baseline (Day 0) - before initiation of maxillary expansion T1: Post-expansion - after completion of 7 mm expansion with RPE or IPE T2: Post-protraction - after 6 months of active maxillary protraction |
| Maxillary dental change |
| T0: Baseline (Day 0) - before initiation of maxillary expansion T1: Post-expansion - after completion of 7 mm expansion with RPE or IPE T2: Post-protraction - after 6 months of active maxillary protraction |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and perceptual experiences and parental involvement associated with the use of Rapid Palatal Expander (RPE) and Invisalign Palatal Expander (IPE). | The functional and perceptual experiences of pediatric patients and their parents, as well as parental involvement in appliance management, will be evaluated through semi-structured face-to-face interviews. Interviews will take place at the Orthodontic Clinic, Faculty of Dentistry, Mahidol University, using a topic guide developed from the study conceptual framework. The interviews will explore appliance-related factors, functional impacts on the child (pain, speech, mastication, and oral hygiene), emotional and perceptual responses of both children and parents, parental involvement in appliance management, treatment compliance, and perceived treatment outcomes. Each interview will last approximately 30 minutes, with audio recording and field notes used for qualitative analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mahidol University | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21889081 | Background | Weissheimer A, de Menezes LM, Mezomo M, Dias DM, de Lima EM, Rizzatto SM. Immediate effects of rapid maxillary expansion with Haas-type and hyrax-type expanders: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2011 Sep;140(3):366-76. doi: 10.1016/j.ajodo.2010.07.025. |
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IPD will not be shared due to information that could compromise the privacy of research participants.
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|
| Rapid Palatal Expander (RPE) | Device | Participants will be treated with a bonded RPE. Their parents are instructed to activate the screw once per day (0.25 mm) until the expansion screw reaches 7 mm. |
|
| Single assessment at 28 days (± 5 days) after appliance insertion |