Universitair Ziekenhuis Gent
Ghent, East Flanders, 9000, Belgium
NCT Number: NCT03981237
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ghent, East Flanders, 9000, Belgium
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:
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
Endodontic Protocol
Irrigation protocol
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: 6, 24, 48, 72 hours after intervention
Number of analgesic tablets (Ibuprofen 400mg) taken at 6, 24, 48 and 72h after intervention
University Hospital, Ghent
Other
Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment: a Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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