Apical PeriodontitisNCT07883486
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
A study testing sonically activated irrigation, laser activated irrigation and conventional needle irrigation in people with Apical Periodontitis and Post Operative Pain, Acute, run by University Ghent at 2 sites in Belgium.
Trial summary
When a tooth's nerve dies, inflammation can develop at the tip of the tooth's root. Root canal treatment is carried out to allow this inflammation to heal. Sometimes, inflammation persists in a tooth that has already undergone root canal treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis, Post Operative Pain, Acute
- What is being tested?
- sonically activated irrigation, laser activated irrigation and conventional needle irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Mature permanent tooth
- Pulpal diagnosis: pulp necrosis, previously initiated treatment, root filled
- Apical diagnosis: asymptomatic apical periodontitis
- Pre-operative pain of 0 on the Visual Analogue Scale (VAS)
Who cannot join
- Permanent teeth with immature roots or open apices
- Teeth not eligible for orthograde (re)treatment
- Teeth with acute pain
- Teeth with periodontal pockets ≥ 5 mm
- Teeth with persistent intracanal drainage
- Non-restorable teeth
Show all 14Show fewer
- Pregnant women
- Patients who took drugs with possible influence on the pain sensation within 12 hours before treatment
- Patients with pain from one or multiple teeth
- Patients with contra-indications for the use of NSAID
- Patients with a known or suspected malignancy
- Patients with a history of chemotherapy within five years
- Patients with a history of radiation therapy in the head and neck region
- Patients with a history of metabolic bone diseases
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
Endo Point
Antwerp, 2000
Maarten Meire, Prof. dr., +3233347077, Maarten.Meire@UGent.be
UZ Gent
Ghent, 9000
Mieke De Bruyne, Prof. dr., +3293324020, Mieke.DeBruyne@uzgent.be
About this study
Official title: Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation: a Multi-centre Randomised Controlled Clinical Trial
When a tooth's nerve dies, inflammation can develop at the tip of the tooth's root. Root canal treatment is carried out to allow this inflammation to heal. Sometimes, inflammation persists in a tooth that has already undergone root canal treatment. In such cases, the root canals may be re-treated to allow the inflammation to heal.
During root canal treatment, the root canals inside the tooth are cleaned and then filled. Various instruments are used to clear the root canal along its entire length, so that the entire canal can be disinfected using antiseptic products. To allow these products to work more effectively, they can be activated. This activation can be achieved, amongst other methods, using vibrations caused by a plastic tip vibrating at a sonic frequency within the liquid. Another method of activation involves the use of a laser, which delivers pulsed energy. This creates shock waves in the liquid. Previous research has shown that root canals can be cleaned more effectively through the use of activation techniques.
This study aims to investigate whether the inflammation present at the root tip heals more effectively following the use of activation methods for the disinfectant. The use of the laser is compared with that of the sonic vibration instrument, and with a group in which the disinfectant is not activated. The effect of the activation method on post-treatment pain is also investigated.
- Conditions
- Apical Periodontitis, Post Operative Pain, Acute
- Being tested
- sonically activated irrigation, laser activated irrigation, conventional needle irrigation
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonically activated irrigationDevice
The irrigant is activated after mechanical preparation with a plastic Eddy-tip (f = 6000 Hz) inserted up to 1 - 3 mm short of the working length. Three 20 s activation cycles are performed per canal, with 2 mL irrigation in each root canal between the cycles.
laser activated irrigationDevice
The irrigant is activated after mechanical preparation with a pulsed Er:YAG laser (Fotona Fidelis III, PIPS, E = 20 mJ, f = 20 Hz, t = 50 μs). These settings result in a power of 0.4 W. Due to the high absorption of the Er:YAG wavelength in the irrigant, mechanical effects occur (cavitation), rather than thermal effects. As a result, the risk of thermal damage is negligible. The tip of the laser is kept at the canal orifice, but not inserted into the root canal. During activation, irrigant is continuously added to the pulp chamber, so the root canals and pulp chamber are consistently immersed in irrigating solution. Three 20 s activating cycles per orifice are executed, with intermittent flushing of the root canal with 2 mL irrigant.
conventional needle irrigationOther
The root canals are irrigated with 3% NaOCl, using a 27G notched needle, adapted to a 3 mL syringe and inserted up to 2 - 3 mm short of working length. Two millilitres of irrigant are used between the different instruments.
| Study group | Role | What they receive |
|---|---|---|
| conventional needle irrigation | Active comparator | Not described Receives: Other: conventional needle irrigation |
| sonically activated irrigation | Experimental | Not described Receives: Device: sonically activated irrigation |
| laser activated irrigation | Experimental | Not described Receives: Device: laser activated irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
The post-operative pain immediately after completion of treatment is scored on the Visual Analogue Scale (VAS), with a score between 0 (no pain) and 10 (worst pain imaginable). Patients are asked to fill out a pain diary 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment with a pain score on the VAS.
Measured: Post-operative pain is scored immediately after the treatment and 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment.
tooth survival
presence of the treated tooth inside the mouth
Measured: up to 2 years post-treatment
apical healing
The pre-operative and recall periapical radiographs are compared for the periapical index (PAI). On the radiographs, the apical periodontitis lesion is outlined and the surface of the lesion is calculated using software. The surface of the apical periodontitis lesion on the follow-up radiograph is compared to the pre-operative radiograph. Teeth are categorized into the following three outcome categories based on analysing the change in the PAI:
- Strict radiographic success (healed teeth): absence of clinical signs or symptoms, and PAI-score of 1 or 2 at follow-up.
- Loose radiographic success (healing teeth): absence of clinical signs or symptoms, and a lower PAI-score (or smaller surface of the lesion) compared to the pre-operative radiograph.
- Failure (non-healing): clinical signs or symptoms (including pain, swelling, sinus tract), or asymptomatic with an unchanged PAI-score (or surface of the lesion), or increase in PAI-score (or surface of the lesion) at follow-up.
Measured: up to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University 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
- Investigator, Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883486
- Sponsor's protocol ID
- ONZ-2026-0189
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation: a Multi-centre Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07883486
- Acronym / sponsor ID
- ONZ-2026-0189
- Conditions
- Apical Periodontitis, Post Operative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 20 Oct 2026 (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.
When a tooth's nerve dies, inflammation can develop at the tip of the tooth's root. Root canal treatment is carried out to allow this inflammation to heal. Sometimes, inflammation persists in a tooth that has already undergone root canal treatment. In such cases, the root canals may be re-treated to allow the inflammation to heal.
During root canal treatment, the root canals inside the tooth are cleaned and then filled. Various instruments are used to clear the root canal along its entire length, so that the entire canal can be disinfected using antiseptic products. To allow these products to work more effectively, they can be activated. This activation can be achieved, amongst other methods, using vibrations caused by a plastic tip vibrating at a sonic frequency within the liquid. Another method of activation involves the use of a laser, which delivers pulsed energy. This creates shock waves in the liquid. Previous research has shown that root canals can be cleaned more effectively through the use of activation techniques.
This study aims to investigate whether the inflammation present at the root tip heals more effectively following the use of activation methods for the disinfectant. The use of the laser is compared with that of the sonic vibration instrument, and with a group in which the disinfectant is not activated. The effect of the activation method on post-treatment pain is also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional needle irrigation | Active comparator | Other: conventional needle irrigation |
| sonically activated irrigation | Experimental | Device: sonically activated irrigation |
| laser activated irrigation | Experimental | Device: laser activated irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years
- Mature permanent tooth
- Pulpal diagnosis: pulp necrosis, previously initiated treatment, root filled
- Apical diagnosis: asymptomatic apical periodontitis
- Pre-operative pain of 0 on the Visual Analogue Scale (VAS)
Key exclusion criteria (14 listed)
- Permanent teeth with immature roots or open apices
- Teeth not eligible for orthograde (re)treatment
- Teeth with acute pain
- Teeth with periodontal pockets ≥ 5 mm
- Teeth with persistent intracanal drainage
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 |
|---|---|---|
| sonically activated irrigationThe irrigant is activated after mechanical preparation with a plastic Eddy-tip (f = 6000 Hz) inserted up to 1 - 3 mm short of the working length. Three 20 s activation cycles are performed per canal, with 2 mL irrigation in each root canal between the cycles. | Device | sonically activated irrigation |
| laser activated irrigationThe irrigant is activated after mechanical preparation with a pulsed Er:YAG laser (Fotona Fidelis III, PIPS, E = 20 mJ, f = 20 Hz, t = 50 μs). These settings result in a power of 0.4 W. Due to the high absorption of the Er:YAG wavelength in the irrigant, mechanical effects occur (cavitation), rather than thermal effects. As a result, the risk of thermal damage is negligible. The tip of the laser is kept at the canal orifice, but not inserted into the root canal. During activation, irrigant is continuously added to the pulp chamber, so the root canals and pulp chamber are consistently immersed in irrigating solution. Three 20 s activating cycles per orifice are executed, with intermittent flushing of the root canal with 2 mL irrigant. | Device | laser activated irrigation |
| conventional needle irrigationThe root canals are irrigated with 3% NaOCl, using a 27G notched needle, adapted to a 3 mL syringe and inserted up to 2 - 3 mm short of working length. Two millilitres of irrigant are used between the different instruments. | Other | conventional needle irrigation |
Primary outcome
post-operative pain
Time frame: Post-operative pain is scored immediately after the treatment and 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment.
The post-operative pain immediately after completion of treatment is scored on the Visual Analogue Scale (VAS), with a score between 0 (no pain) and 10 (worst pain imaginable). Patients are asked to fill out a pain diary 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment with a pain score on the VAS.
tooth survival
Time frame: up to 2 years post-treatment
presence of the treated tooth inside the mouth
apical healing
Time frame: up to 2 years post-treatment
The pre-operative and recall periapical radiographs are compared for the periapical index (PAI). On the radiographs, the apical periodontitis lesion is outlined and the surface of the lesion is calculated using software. The surface of the apical periodontitis lesion on the follow-up radiograph is compared to the pre-operative radiograph. Teeth are categorized into the following three outcome categories based on analysing the change in the PAI: * Strict radiographic success (healed teeth): absence of clinical signs or symptoms, and PAI-score of 1 or 2 at follow-up. * Loose radiographic success (healing teeth): absence of clinical signs or symptoms, and a lower PAI-score (or smaller surface of the lesion) compared to the pre-operative radiograph. * Failure (non-healing): clinical signs or symptoms (including pain, swelling, sinus tract), or asymptomatic with an unchanged PAI-score (or surface of the lesion), or increase in PAI-score (or surface of the lesion) at follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sonically activated irrigation, laser activated irrigation and conventional needle irrigation in people with Apical Periodontitis and Post Operative Pain, Acute, run by University Ghent at 2 sites 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mieke De Bruyne, Prof. dr. (+3293324020, Mieke.DeBruyne@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: Post-operative pain is scored immediately after the treatment and 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.