Pulp Disease, Dental
Conditions
Brief summary
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.
Detailed description
Conventional 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. GentleWave®, EdgePRO™, and Fotona LightWalker® are advanced endodontic irrigation systems approved by the Federal Drug Administration as medical devices to prepare, clean, and irrigate root canal anatomy during endodontic therapy. The study compares the post-operative outcome between 4 groups: conventional needle irrigation, irrigation with GentleWave®, irrigation with EdgePRO™, and irrigation with Fotona LightWalker® in root canal treatments. Participants will be asked to report the level of post-operative pain by telephone at approximately 6, 24, 48, and 72 hours after treatment. Each pain assessment will take less than one minute. Participants will also be asked to return to the clinic for follow-up examinations at approximately 6 and 12 months after treatment. Each follow-up visit will take approximately 30 minutes.
Interventions
DEVICEGentleWave®
An 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.
DEVICEEdgePRO™
An 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.
DEVICEFotona LightWalker®
An 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 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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analyst/statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults older than 18 years of age who need root canal treatment.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain intensity as assessed by the Numeric Rating Scale (NRS, 0-10) | 6, 24, 48, and 72 hours post-treatment | 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) | 6- and 12-months post-treatment | 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) | 6 month and 12 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | At 6, 24, 48, and 72 hours post-treatment | Binary: present/absent |
Countries
United States
Contacts
CONTACTAnh M Bui, DMD
CONTACTQian Xie, BDS, MS, PhD
PRINCIPAL_INVESTIGATORQian Xie, BDS, MS, PhD
University of Illinois at Chicago
Outcome results
None listed