Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Level of post-operative pain after 72 hours
Study Overview
Brief Summary
The aim of this prospective, randomized clinical study is to compare the frequency and intensity of post-operative pain after root canal treatment with ultrasonically-activated or laser-activated irrigation.
Detailed Description
Patients older than 18 years who require root canal treatment of an asymptomatic tooth with vital or necrotic pulp are included. Those teeth are subjected to root canal treatment using hand and rotating/reciprocating instruments, in combination with irrigation (3% NaOCl, 17% EDTA). After chemomechanical preparation, the teeth are randomly allocated to one of the following groups, according to the final irrigant activation:
- Ultrasonically activated irrigation (UAI), with an Irrisafe file (Satelec Acteon, Mérignac, France) held 1-3mm from working length, driven by an ultrasonic device, activated for 3 x 20 seconds. In between each 20-second cycle, each canal is rinsed with 1 mL NaOCl and finally with 2 mL.
- Laser-activated irrigation (LAI), with the tip of a pulsed Er:YAG laser (2940 nm, Fidelis II, Fotona) held above the canal entrance, activated for 2 x 30s. Settings are 20 Hz, 50 μs, 20 mJ. In between each 30-second cycle, each canal is rinsed with 1 mL NaOCl and finally with 2 mL.
The canals are then dried using paper points and obturated with gutta percha and an epoxy resin sealer using warm vertical condensation. Finally, the endodontic access is sealed with a provisional or permanent filling.
The patient is asked to keep a pain diary after the treatment, indicating postoperative pain on a visual analogue scale at 6, 24, 48 and 72 hours after treatment. Pain medication (Ibuprofen 400mg) is prescribed, and the intake of analgesic tablet is recorded at the same times.
Pre-Treatment Procedure
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
- •subject must be able to undergo primary endodontic treatment
Exclusion Criteria
- •analgesic intake over the last 12h
- •immunocompromised patients
- •pregnant women
- •tooth with incompletely formed apex/apices
- •subjects with more than one tooth in need of RCT
- •previously root canal treated teeth
- •subjects with intolerance on NSAID's
Arms & Interventions
Root canal treatment with laser-activated irrigation
In these patients, the root canals of the tooth are chemomechanically prepared. After shaping, irrigant activation is performed by means of a pulsed erbium laser. The canals are then dried and obturated.
Intervention: Laser-activated irrigation with a pulsed Er:YAG laser (Device)
Root canal treatment with laser-activated irrigation
In these patients, the root canals of the tooth are chemomechanically prepared. After shaping, irrigant activation is performed by means of a pulsed erbium laser. The canals are then dried and obturated.
Intervention: Orthograde root canal treatment (Procedure)
Root canal treatment with ultrasonically activated irrigation
In these patients, the root canals of the tooth are chemomechanically prepared. After shaping, irrigant activation is performed by means of an ultrasonically driven instrument. The canals are then dried and obturated.
Intervention: Ultrasonically activated irrigation (Device)
Root canal treatment with ultrasonically activated irrigation
In these patients, the root canals of the tooth are chemomechanically prepared. After shaping, irrigant activation is performed by means of an ultrasonically driven instrument. The canals are then dried and obturated.
Intervention: Orthograde root canal treatment (Procedure)
Outcomes
Primary Outcomes
Level of post-operative pain after 72 hours
Time Frame: 72 hours after intervention
Self-reported pain intensity at 72h after intervention, indicated on a 100mm Visual Analogue Scale. The VAS is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable.
Level of post-operative pain after 24 hours
Time Frame: 24 hours after intervention
Self-reported pain intensity at 24h after intervention, indicated on a 100mm Visual Analogue Scale. The VAS is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable.
Level of post-operative pain after 6 hours
Time Frame: 6 hours after intervention
Self-reported pain intensity at 6h after intervention, indicated on a 100mm Visual Analogue Scale. The VAS is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable.
Level of post-operative pain after 48 hours
Time Frame: 48 hours after intervention
Self-reported pain intensity at 48h after intervention, indicated on a 100mm Visual Analogue Scale. The VAS is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable.
Secondary Outcomes
- Analgesic intake(6, 24, 48, 72 hours after intervention)