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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Pulp Necrosis
• Intervention / Treatment: Procedure: Local anaesthetic injection of 4% articaine with 1:100000 epinephrine; Procedure: Tooth isolation; Procedure: Access cavity preparation; Procedure: Root canal shaping and cleaning; Procedure: Final irrigation with antimicrobial-corticosteroid mixture; Procedure: Temporary restoration and patient's instructions; Procedure: Root canal obturation; Procedure: Final irrigation with cold saline

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12613
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients in good physical health; American Society of Anesthesiologists class I or II.
2. Patients whose age ranges between 18 and 50 years.
3. Male and female patients.
4. Patients having a single canal-tooth with necrotic pulp.
5. Patients who can understand the number rating scale (figure).
6. Patients who accept to participate in the trial and can sign the informed consent (figure).

Exclusion Criteria:

1. Pregnant females.
2. Patients with swelling.
3. Patients whose tooth is non-restorable.
4. Teeth with open apices.
5. Teeth with radiographic evidence of root resorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antimicrobial Corticosteroid mixture; Each canal will receive 5 minutes of final irrigation with the antimicrobial-corticosteroid solution of a freshly prepared mixture of: 1 ml of Levofloxacin (Tavanic, Sanofi Aventis, Egypt). 1 ml of Fluconazole (Sunny fungal, Sunny pharmaceuticals, Egypt). 1 ml of Dexamethasone sodium phosphate (Dexamethasone, Amriya, Egypt).	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: 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.
Active Comparator: Cryotherapy; Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.	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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postinstrumentation pain	Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain	At 6 hours after the 1st visit
Postinstrumentation pain	Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain	At 12 hours after the 1st visit
Postinstrumentation pain	Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain	At 24 hours after the 1st visit
Postinstrumentation pain	Pain as reported by the patient on a Numerical rating scale from 0 to 10 where 0 indicates no pain and 10 indicates the worst possible pain	At 48 hours after the 1st visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti bacterial effect	percentage of bacterial reduction after final irrigation as compared to after instrumentation. Cultures from collected paper points will be inoculated in sterile brain heart infusion (BHI) broth vials which will be dispersed with vortex for 30 seconds. The sterile BHI broth solution will then be serially diluted one-tenth dilution and plated onto the blood agar medium and incubated at 37°C aerobically for 24 hours. The resultant bacterial growth will be quantified by evaluating the number of colonies on the agar medium & the number of CFU/ml of each dilution will be calculated for each sample.	At 24 hours after the 1st visit
Antifungal effect	Percentage of Candidal reduction after final irrigation as compared to after instrumentation. Cultures from collected paper points will be inoculated in sterile brain heart infusion (BHI) broth vials which will be dispersed with vortex for 30 seconds. The sterile BHI broth solution will be serially diluted one-tenth dilution and plated onto Sabouraud dextrose agar medium and incubated at 25°C aerobically for 48 hours. The resultant candida growth will be quantified by evaluating the number of colonies on the agar medium & the number of CFU/ml of each dilution will be calculated for each sample.	At 48 hours after the 1st visit

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Maged M Negm, Professor in Endodontics, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): February 9, 2025

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Corticosteroid; Antibiotic; Cryotherapy; Antifungal
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Dental Pulp Necrosis; Necrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Anesthetics; Anti-Bacterial Agents; Anesthetics, Local; Epinephrine; Anti-Infective Agents; Carticaine
• Other Study ID Numbers: ENDO 18-11-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are planning to share individual patient's data regarding age, gender, preoperative pain score and outcome data
• IPD Sharing Time Frame: From 1/6/2024 - Forever
• IPD Sharing Access Criteria: Anyone with the link can view the supporting information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No