2 Clinical Trials for Various Conditions
Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.
The goal of this clinical trial is to determine whether an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can reduce pain during orthodontic alignment and leveling in adolescents and adults. The study aims to compare the effectiveness of the TENS device in reducing pain on one side of the mouth, where the device is used, to the other side, where a non-functioning (placebo) device is applied. The primary questions this study aims to answer are: Does the TENS device effectively reduce pain during orthodontic treatment compared to the placebo? How do patients pain levels differ between the treated and untreated sides of the mouth? Participants will: Have an orthodontic appliance placed on their teeth. Experience the TENS device being applied to one side of their mouth for 2.5 minutes immediately after the appliance placement (brackets and wires). Report their pain levels at various intervals after the procedure (immediately, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours). This study includes up to 150 participants who are undergoing routine orthodontic treatment. The findings will help researchers understand whether the TENS device can effectively reduce discomfort during orthodontic procedures, potentially leading to better patient care and comfort.