Study: NCT05739682

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
Description: Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
Description: Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Tooth isolation
Description: Rubber dam application to the affected tooth

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Tooth isolation
Description: Rubber dam application to the affected tooth

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Access cavity preparation
Description: Complete removal of caries, undermined tooth structure, and defective restoration. Access cavity preparation with complete removal of the pulp chamber roof using a sterile bur other than the ones used for caries removal.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Access cavity preparation
Description: Complete removal of caries, undermined tooth structure, and defective restoration. Access cavity preparation with complete removal of the pulp chamber roof using a sterile bur other than the ones used for caries removal.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Root canal shaping and cleaning
Description: Working length determination using an electronic apex locator and then canal instrumentation using Hyflex CM rotary files up to size 40.04 with irrigation using 2.5% NaOCl between files.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Root canal shaping and cleaning
Description: Working length determination using an electronic apex locator and then canal instrumentation using Hyflex CM rotary files up to size 40.04 with irrigation using 2.5% NaOCl between files.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Final irrigation with antimicrobial-corticosteroid mixture
Description: 1 ml of levofloxacin will be withdrawn in a 3ml plastic syringe followed by 1 ml of fluconazole and 1 ml of dexamethasone sodium phosphate, the whole solution is then passively delivered into the canal using a 30-gauge side vented needle reaching 1 mm shorter than the working length. The solution will be left inside the canal for 5 minutes

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Final irrigation with cold saline
Description: Frozen sterile saline will be brought at room temperature and monitored using a digital liquid thermometer till the temperature reaches 2.5°c. 4ml are then withdrawn in a 5ml plastic syringe and delivered inside the canal in 1 minute. The process is then repeated 5 times so that the canal receives 20 ml of 2.5°c cold saline for 5 minutes.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Temporary restoration and patient's instructions
Description: The canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Temporary restoration and patient's instructions
Description: The canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Root canal obturation
Description: After the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Root canal obturation
Description: After the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation.