Clinical trial NCT03981237: Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment
Official title: Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Keywords: root canal treatment
root canal irrigation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2019-06-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Level of post-operative pain after 24 hours
timeFrame: 24 hours after intervention
measure: Level of post-operative pain after 6 hours
timeFrame: 6 hours after intervention
measure: Level of post-operative pain after 48 hours
timeFrame: 48 hours after intervention
measure: Level of post-operative pain after 72 hours
timeFrame: 72 hours after intervention
Secondary outcomes:
measure: Analgesic intake
timeFrame: 6, 24, 48, 72 hours after intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: East Flanders
Study officials:
References:
citation: Liapis D, De Bruyne MAA, De Moor RJG, Meire MA. Postoperative pain after ultrasonically and laser-activated irrigation during root canal treatment: a randomized clinical trial. Int Endod J. 2021 Jul;54(7):1037-1050. doi: 10.1111/iej.13500. Epub 2021 Mar 9.