Post-operative pain remains a frequent complication after root canal treatments. This clinical trial evaluates the post-operative outcome following endodontic treatments using four irrigation approaches: conventional needle irrigation, GentleWave®, EdgePRO™, and Fotona LightWalker®. The study will assess patients' post-operative pain and other symptoms following treatment, as well as healing of the tissues around the treated tooth over time.
Adults older than 18 years of age who need root canal treatment.
The intake of analgesics within the previous 8h, substance abuse, additional pulpal pathology on the same side, systemic conditions classified as ASA III or higher.
Adults unable to consent, minors less than 18 years of age, pregnant women, and prisoners
Parallel
GentleWave®
DeviceAn advanced endodontic irrigation system that utilizes a vortex of fluids and acoustic energy that cleans the deepest, most complex portions of the root canal system. Regulatory approval status: FDA cleared Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
EdgePRO™
DeviceAn advanced endodontic irrigation system that delivers Laser Light Sound Energy at a specific wavelength and frequency to the irrigants in the canal to form Cavitation Waves throughout the root canal system. This allows optimal cleaning, debridement, and disinfection of the root canal system. Regulatory approval status: FDA cleared Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
Fotona LightWalker®
DeviceAn advanced endodontic irrigation system that combines Er:YAG and Nd:YAG wavelengths to optimize pulse control, intuitive interface, and minimally invasive approach to enhance patient outcomes, improve efficiency, and expand clinical capabilities. Regulatory approval status: FDA cleared Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
Conventional Needle Irrigation
DeviceConventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy. Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
Post-operative pain intensity as assessed by the Numeric Rating Scale (NRS, 0-10)
Pain intensity self-reported on an 11-point Numeric Rating Scale where 0 = no pain and 10 = worst possible pain. The metric is the mean NRS score per group, reported separately at each time point. Higher scores indicate worse pain.
Number of teeth with radiographic periapical healing as assessed by the Periapical Index (PAI)
Periapical status scored on the 5-point PAI (1 = normal periapical structures; 2 = small bone-structure changes; 3 = bone-structure changes with mineral loss; 4 = well-defined apical radiolucency; 5 = severe periodontitis with exacerbating features) on periapical radiographs by two calibrated, blinded, independent assessors, with a third assessor arbitrating disagreements. For multirooted teeth the highest root score is recorded. Based on the change in PAI between baseline and follow-up, each tooth is classified into one of three categories: 1. Healing (complete healing): final PAI ≤ 2 with no clinical signs or symptoms (complete radiographic resolution). 2. Incomplete healing: final PAI reduced compared with baseline but still \> 2, with no clinical signs or symptoms (lesion reduced in size but not fully resolved). 3. Unhealed: PAI unchanged or increased, and/or presence of clinical signs/symptoms (pain, swelling, sinus tract). Reported as the proportion (number/total) of teeth.
Number of teeth meeting clinical success criteria (absence of pain, swelling, sinus tract, and normal function)
Clinical success defined as a tooth with no spontaneous or provoked pain, no tenderness to percussion/palpation, no swelling, no sinus tract, and normal function. Reported as the proportion (number/total) of teeth meeting all criteria per group.
Analgesic consumption
Binary: present/absent
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