Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment
- Conditions
- Post-operative Pain
- Interventions
- Procedure: Orthograde root canal treatmentDevice: Ultrasonically activated irrigation
- Registration Number
- NCT03981237
- Lead Sponsor
- University Hospital, Ghent
- 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
* Medical + dental history
* Clinical examination: sensibility tests, percussion, palpation, mobility, pockets measurement
* Radiographic examination
* Pulpal and periapical diagnosis
* Intensity of pre-op pain on 100mm VAS scale
* Patient information and informed consent
* Explanation on how to complete the pain diary and how and when to return it
Endodontic Protocol
* Anesthesia
* Rubber dam, disinfection of operative field
* Removal of caries and/or defective restorations
* Access cavity
* Build-up to provide a reservoir for the irrigation if necessary
* Crown-down preparation
* Length determination
* Apical enlargement
Irrigation protocol
* 3% NaOCl
* 17% EDTA when shaping completed
* Irrigation throughout the whole procedure with 27G notched-end needle 2 - 3 mm from WL
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
- subject must be able to undergo primary endodontic treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Root canal treatment with laser-activated irrigation Orthograde root canal treatment 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. Root canal treatment with ultrasonically activated irrigation Orthograde root canal treatment 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. Root canal treatment with ultrasonically activated irrigation 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.
- Primary Outcome Measures
Name Time Method Level of post-operative pain after 72 hours 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 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 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 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 Outcome Measures
Name Time Method Analgesic intake 6, 24, 48, 72 hours after intervention Number of analgesic tablets (Ibuprofen 400mg) taken at 6, 24, 48 and 72h after intervention
Trial Locations
- Locations (1)
Universitair Ziekenhuis Gent
🇧🇪Ghent, East Flanders, Belgium