Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2019
CompletedFirst Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedMarch 16, 2021
April 1, 2020
12 months
May 27, 2019
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
24 hours after intervention
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.
6 hours after intervention
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.
48 hours after intervention
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.
72 hours after intervention
Secondary Outcomes (1)
Analgesic intake
6, 24, 48, 72 hours after intervention
Study Arms (2)
Root canal treatment with laser-activated irrigation
EXPERIMENTALIn 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
ACTIVE COMPARATORIn 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.
Interventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
- subject must be able to undergo primary endodontic treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- University Ghentcollaborator
Study Sites (1)
Universitair Ziekenhuis Gent
Ghent, East Flanders, 9000, Belgium
Related Publications (1)
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.
PMID: 33595920DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2019
First Posted
June 10, 2019
Study Start
March 25, 2019
Primary Completion
March 13, 2020
Study Completion
March 13, 2020
Last Updated
March 16, 2021
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share