Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment

NCT ID: NCT03981237

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-03-13

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Root canal treatment with laser-activated irrigation

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.

Group Type: EXPERIMENTAL

Laser-activated irrigation with a pulsed Er:YAG laser

Intervention Type: DEVICE

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.

Orthograde root canal treatment

Intervention Type: PROCEDURE

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.

Root canal treatment with ultrasonically activated irrigation

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.

Group Type: ACTIVE_COMPARATOR

Ultrasonically activated irrigation

Intervention Type: DEVICE

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 treatment

Intervention Type: PROCEDURE

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.

Interventions

Laser-activated irrigation with a pulsed Er:YAG laser

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.

Intervention Type: DEVICE

Ultrasonically activated irrigation

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).

Intervention Type: DEVICE

Orthograde root canal treatment

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
• subject must be able to undergo primary endodontic treatment

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Gent

Ghent, East Flanders, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 33595920 (View on PubMed)

Other Identifiers

B670201939441

Identifier Type: -

Identifier Source: org_study_id