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
Qualifiers
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
Treatments tested in this trial
- Invisalign Palatal Expander (IPE)
- Rapid Palatal Expander (RPE)