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Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Laser-activated irrigation with a pulsed Er:YAG laser
Ultrasonically activated irrigation
Orthograde root canal treatment
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring root canal treatment, root canal irrigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Gent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Root canal treatment with laser-activated irrigation

Root canal treatment with ultrasonically activated irrigation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Level of post-operative pain after 24 hours
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
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
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.
Level of post-operative pain after 72 hours
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.

Secondary Outcome Measures

Analgesic intake
Number of analgesic tablets (Ibuprofen 400mg) taken at 6, 24, 48 and 72h after intervention

Full Information

First Posted
May 27, 2019
Last Updated
March 15, 2021
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03981237
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
root canal treatment, root canal irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Root canal treatment with laser-activated irrigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Root canal treatment with ultrasonically activated irrigation
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Laser-activated irrigation with a pulsed Er:YAG laser
Intervention Description
The root canals and the pulp chamber are filled with NaOCl 3%. Per canal, the laser tip is placed above the root canal entrance and activated (frequency 20 Hz, pulse energy 20 mJ and pulse length 50 μs) for 30s. TThe canal is then rinsed with NaOCl using a 27G needle, followed by a second application of laser, identical to the first.
Intervention Type
Device
Intervention Name(s)
Ultrasonically activated irrigation
Intervention Description
The root canals and the pulp chamber are filled with NaOCl 3%. An Irrisafe file, driven by an ultrasonic unit according to the manufacturers' instructions, is held at 1-3 mm from WL (precurved if canal is curved) and activated for 30 s. The canal is then rinsed with NaOCl using a 27G needle. This cycle is repeated three times (i.e. 3*20s).
Intervention Type
Procedure
Intervention Name(s)
Orthograde root canal treatment
Intervention Description
After rubber dam isolation and field disinfection, the pulp chamber is accessed. The root canal(s) is/are located and shaped using manual and mechanical NiTi instruments in combination with NaOCl (3%) irrigant. The canals are dried using paper points and obturated with gutta percha and epoxy resin sealer. The tooth is sealed with a temporary or permanent filling.
Primary Outcome Measure Information:
Title
Level of post-operative pain after 24 hours
Description
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.
Time Frame
24 hours after intervention
Title
Level of post-operative pain after 6 hours
Description
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.
Time Frame
6 hours after intervention
Title
Level of post-operative pain after 48 hours
Description
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.
Time Frame
48 hours after intervention
Title
Level of post-operative pain after 72 hours
Description
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.
Time Frame
72 hours after intervention
Secondary Outcome Measure Information:
Title
Analgesic intake
Description
Number of analgesic tablets (Ibuprofen 400mg) taken at 6, 24, 48 and 72h after intervention
Time Frame
6, 24, 48, 72 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33595920
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.
Results Reference
derived

Learn more about this trial

Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment

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