Abstract
INTRODUCTION: The rubber dam isolation technique is widely used in endodontics to improve visibility and access, yet it often causes patient discomfort, especially for those with difficulty breathing through their nose. To address this, a new patented mouth breathing device (MBD) was developed to enhance patient comfort by facilitating easier mouth breathing during rubber dam isolation. This study aims to evaluate the breathing convenience and clinical acceptance of the MBD. METHODS: In a randomized clinical trial, 36 patients undergoing endodontic procedures with rubber dam isolation were recruited. Participants were randomly assigned to either the experimental group (MBD) or the control group (no device). A custom-developed questionnaire was used to assess patient comfort, ease of breathing, and overall satisfaction with the procedure. Clinicians also provided feedback on the device's impact on treatment efficiency, patient cooperation, and clinical outcomes. Data were analyzed using statistical tests to compare the results between the two groups. RESULTS: The study evaluated 36 participants, evenly divided into two groups with a significant age difference (p = 0.04). Group A (Test) showed improved outcomes, including reduced blood pressure (SBP: 14.12 mmHg, DBP: 16.76 mmHg) and increased oxygen saturation (SpO2: +5.71 %, p < 0.001). In contrast, Group B (Control) showed worsened outcomes with increased blood pressure and decreased SpO2 (-6.12 %, p < 0.001). CONCLUSION: The patented mouth breathing device offers significant benefits in terms of breathing convenience and patient comfort during rubber dam isolation. The device appears to be a promising adjunct to improve clinical outcomes by reducing patient anxiety and discomfort.