Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorMahidol University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 8 and 12 years
Patients in the mixed dentition or early permanent stage have at least three stable teeth per quadrant, good oral hygiene, and healthy periodontal tissues
Patients with maxilla-mandibular discrepancies; skeletal class III is indicated by an ANB angle < 0 degrees or a Wits appraisal value that is negative, and Maxillary constriction is characterized by posterior crossbite teeth or having a maxillary width below the norm value.
Disqualifiers
Patients with craniofacial anomalies such as cleft lip and palate
Patient with a prior history of maxillary expansion.
Patients who have systemic conditions that contraindicate orthodontic treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Invisalign Palatal Expander (IPE)
DeviceParticipants 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.
Rapid Palatal Expander (RPE)
DeviceParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Invisalign Palatal Expander (IPE) groupExperimental treatment 1 intervention
Group B: Rapid Palatal Expander (RPE) groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maxillary skeletal change
* Anterior and posterior midpalatal suture width * Anterior apical base width inferior * Anterior apical base width superior * Posterior apical base width * Anterior width at mid-alveolar level * Posterior width at alveolar crest level
Time frame
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 protraction2
Maxillary dental change
* Intermolar width at occlusal surface * Intermolar width at palatal root apices * Right first molar angulation * Left first molar angulation
Time frame
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 protractionSecondary outcomes
1
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.
Time frame
Single assessment at 28 days (± 5 days) after appliance insertionSponsors and contacts
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Source ClinicalTrials.gov
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