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

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.

Conditions

• Dental Pulp Necrosis

Interventions

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1 ml of levofloxacin will be withdrawn in a 3ml plastic syringe followed by 1 ml of fluconazole and 1 ml of dexamethasone sodium phosphate, the whole solution is then passively delivered into the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at room temperature and monitored using a digital liquid thermometer till the temperature reaches 2.5°c. 4ml are then withdrawn in a 5ml plastic syringe and delivered inside the canal in 1 minute.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.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Maged M Negm, Professor in Endodontics · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2025-01-30

Completion

2025-02-09

Countries

• Egypt

Study Locations