An interventional study of sonically activated irrigation and laser activated irrigation in Apical Periodontitis and Post Operative Pain, Acute, sponsored by University Ghent. Not yet recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
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.
256 studies on the registry are indexed under Periapical Periodontitis; 65 are open to participants now.
This study's planned enrollment of 183 is above the median of 60 across 222 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →University Ghent is the lead sponsor of 349 studies on the registry; 86 are open to participants now.
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Exclusion criteria:
Other: conventional needle irrigation
Device: sonically activated irrigation
Device: laser activated irrigation
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.
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.
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.
post-operative pain
The post-operative pain immediately after completion of treatment is scored with the Visual Analogue Scale (VAS). 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.
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.
tooth survival
presence of the treated tooth inside the mouth
Time frame: 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.
Time frame: up to 2 years post-treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2029, 34 months later.
Of 151 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 34 months is above that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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