Comparison between two screws for maxillary expansion: a multicenter randomized controlled trial on patient's...

Area of Science:

• Orthodontics
• Biomaterials Science
• Patient-Reported Outcomes

Background:

• Rapid maxillary expansion (RME) is a common orthodontic procedure to correct transverse discrepancies.
• Conventional RME screws deliver intermittent, heavy forces, which can cause patient discomfort and pain.
• Novel devices aim to improve patient experience by modifying force delivery during RME.

Purpose of the Study:

• To compare patient-reported outcomes between a novel expansion screw (Leaf group) delivering moderate, continuous forces and a conventional RME screw (RME group).
• To assess pain, difficulty with speech and oral hygiene, patient satisfaction, and complications during the initial 12 weeks of RME treatment.

Main Methods:

• A superiority, multicenter, two-arm parallel balanced randomization trial was conducted.
• Patients with transverse discrepancies (≥3 mm) in mixed dentition were randomized into the Leaf group (Ni-Ti springs) or RME group (conventional screw).
• Pain was measured using the Visual Analogue Scale (VAS); other outcomes included speech, hygiene, satisfaction, and complications.

Main Results:

• No dropouts occurred in either group (n=28 per group).
• The Leaf group reported significantly lower mean VAS pain scores (-0.3; P=0.017) compared to the RME group.
• Pain reduction was most pronounced in the first week, with the Leaf group experiencing significantly less pain (difference -1.5; P=0.019).

Conclusions:

• The Leaf expansion screw, utilizing moderate continuous forces, leads to reduced pain during the initial phase of rapid maxillary expansion.
• No significant differences were observed between the two groups for other evaluated patient-reported outcomes.
• This suggests that continuous force delivery may enhance patient comfort during RME treatment.