Post-operative PainNCT03981237
Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment
A study testing Laser-activated irrigation with a pulsed Er:YAG laser, Ultrasonically activated irrigation and Orthograde root canal treatment in people with Post-operative Pain, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Laser-activated irrigation with a pulsed Er:YAG laser, Ultrasonically activated irrigation and Orthograde root canal treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Mar 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
- subject must be able to undergo primary endodontic treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment: a Randomized Clinical Trial
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.
Read the 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
- Conditions
- Post-operative Pain
- Being tested
- Laser-activated irrigation with a pulsed Er:YAG laser, Ultrasonically activated irrigation, Orthograde root canal treatment
- Keywords
- root canal treatment, root canal irrigation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-activated irrigation with a pulsed Er:YAG laserDevice
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.
Ultrasonically activated irrigationDevice
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).
Orthograde root canal treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment with laser-activated irrigation | Experimental | 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. Receives: Device: Laser-activated irrigation with a pulsed Er:YAG laser; Procedure: Orthograde root canal treatment |
| Root canal treatment with ultrasonically activated irrigation | Active comparator | 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. Receives: Device: Ultrasonically activated irrigation; Procedure: Orthograde root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 hours after intervention
Secondary outcomes (1)
Analgesic intake
Number of analgesic tablets (Ibuprofen 400mg) taken at 6, 24, 48 and 72h after intervention
Measured: 6, 24, 48, 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start25 Mar 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981237
- Sponsor's protocol ID
- B670201939441
- Status last verified
- Apr 2020
- First submitted
- 27 May 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33595920
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03981237
- Acronym / sponsor ID
- B670201939441
- Conditions
- Post-operative Pain
- Keywords
- root canal treatment, root canal irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment with laser-activated irrigation | Experimental | Device: Laser-activated irrigation with a pulsed Er:YAG laser, Procedure: Orthograde root canal treatmentIn 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 comparator | Device: Ultrasonically activated irrigation, Procedure: Orthograde root canal treatmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
- subject must be able to undergo primary endodontic treatment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-activated irrigation with a pulsed Er:YAG laserThe 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. | Device | Root canal treatment with laser-activated irrigation |
| Ultrasonically activated irrigationThe 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). | Device | Root canal treatment with ultrasonically activated irrigation |
| Orthograde root canal treatmentAfter 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. | Procedure or surgery | Root canal treatment with laser-activated irrigation, Root canal treatment with ultrasonically activated irrigation |
Primary outcome
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.
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.
1 secondary outcome
Analgesic intake
Time frame: 6, 24, 48, 72 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Derived from this study: PubMed 33595920Liapis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-activated irrigation with a pulsed Er:YAG laser, Ultrasonically activated irrigation and Orthograde root canal treatment in people with Post-operative Pain, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of post-operative pain after 24 hours (time frame: 24 hours after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.