NCT05739682

Pain and Microbial Reduction of Antimicrobial Corticosteroid Mixture Versus Cryotherapy in Necrotic Teeth

The Effect of Final Irrigation Using Antimicrobial-corticosteroid Mixture Versus Cryotherapy on Post-instrumentation Pain and Microbial Reduction in Patients Having Single Canal - Teeth With Necrotic Pulps: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the effect of antimicrobial-corticosteroid mixture and cryotherapy as final root canal irrigating solutions on post-instrumentation pain in single-canal teeth with necrotic pulps.

Detailed description

The trial participants are patients with single-canal teeth with necrotic pulps undergoing root canal treatment on two visits. During the 1st visit, access cavity, root canal cleaning and shaping using rotary files and 2.5% NaOCl irrigation. After apical preparation, a final flush with either a levofloxacin-fluconazole-dexamethasone mixture or cold saline will be used then the tooth access cavity will be sealed with a temporary filling. After the first visit, the participants will be given a pain chart with a numerical rating scale to rate their pain levels from zero to 10 at 6, 12, 24, and 48 hours. Three microbial swabs will be collected for each participant: before instrumentation (S1), after instrumentation before final irrigation (S2), and after final irrigation (S3). After collecting data from all participants, statistical analysis will be conducted to compare the pain intensity and microbial load reduction percentages between the two groups.

Conditions

• Dental Pulp Necrosis

Interventions

Type	Name	Description
PROCEDURE	Local anaesthetic injection of 4% articaine with 1:100000 epinephrine	Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle
PROCEDURE	Tooth isolation	Rubber dam application to the affected tooth
PROCEDURE	Access cavity preparation	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.
PROCEDURE	Root canal shaping and cleaning	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.
PROCEDURE	Final irrigation with antimicrobial-corticosteroid mixture	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
PROCEDURE	Final irrigation with cold saline	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.
PROCEDURE	Temporary restoration and patient's instructions	The canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling.
PROCEDURE	Root canal obturation	After the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-01-30
• Completion: 2025-02-09
• First posted: 2023-02-22
• Last updated: 2025-06-05

Locations

1 site across 1 country: Egypt