3D-Printed anterior repositioning splint versus stabilization splint for patients with anterior disc displacement with reduction: A randomized cross-over clinical trial.

Abstract

Aim: The aim of this study was to compare the improvement of pain between a digitally constructed stabilization splint (SS) and anterior repositioning splint (ARS) for patients with anterior disc displacement with reduction (DDWR).

Settings and design: The trial was a cross-over randomized control trial.

Materials and methods: Twenty patients were diagnosed using magnetic resonance imaging to have anterior disc displacement were included in the following trial. All included patients met the inclusion criteria and they were all suffering from pain and were classified as anterior DDWR. They were randomized using the sealed envelopes into two groups. Group A patients received ARS for 3 months and then SS for another 3 months after a 14-day wash out period, while in group B patients received SS for 3 months and then ARS for another 3 months after a wash out period of 14 days. All included patients received a primary impression followed by a centric relation record and a protrusive record for the fabrication of the splints. All splints were designed and then printed. Pain was evaluated using the Visual Analog Scale (VAS), an easy subjective proportion of pain intensity using a scale from 0 to 10, where 0 indicates no pain and 10 indicates high intensity.

Statistical analysis used: An independent t-test was performed for both groups at each fixed time interval.

Results: There was a statistically significant difference within absolute change in pain reduction for both groups over the 3-month follow-up period. During the 1st week, Group B showed a greater pain reduction compared to Group A (0.43 vs. 0.32, respectively; P = 0.0001). However, at the 2nd week, 1 month, 2 months, and 3 months, Group A demonstrated greater pain reduction than Group B, with the values of (0.87, 1.5, 1.54, and 1.82) for Group A and (0.81, 1.19, 1.43, and 1.78) for Group B, respectively (P = 0.0001).

Conclusion: Within the limitations of this study, both splints are considered reliable treatment options for patients with anterior disc displacement. The ARS initially demonstrated a greater improvement in pain compared to the SS. However, after the 3-month follow-up period, no significant difference was observed between the two splints.