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

NCT05739682 | Completed

• 1 other identifier: ENDO 18-11-21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Antibiotic; Antifungal; Corticosteroid; Cryotherapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Anti bacterial effect

  At 24 hours after the 1st visit

• Antifungal effect

  At 48 hours after the 1st visit

Study Arms (2)

Antimicrobial Corticosteroid mixture

EXPERIMENTAL

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; 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

Cryotherapy

ACTIVE COMPARATOR

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; Procedure: Tooth isolation; Procedure: Access cavity preparation; Procedure: Root canal shaping and cleaning; Procedure: Final irrigation with cold saline; Procedure: Temporary restoration and patient's instructions; Procedure: Root canal obturation

Interventions

Local anaesthetic injection of 4% articaine with 1:100000 epinephrine PROCEDURE

Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle

Antimicrobial Corticosteroid mixture; Cryotherapy

Tooth isolation PROCEDURE

Rubber dam application to the affected tooth

Antimicrobial Corticosteroid mixture; Cryotherapy

Access cavity preparation PROCEDURE

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.

Antimicrobial Corticosteroid mixture; Cryotherapy

Root canal shaping and cleaning PROCEDURE

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.

Antimicrobial Corticosteroid mixture; Cryotherapy

Final irrigation with antimicrobial-corticosteroid mixture PROCEDURE

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

Antimicrobial Corticosteroid mixture

Final irrigation with cold saline PROCEDURE

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.

Cryotherapy

Temporary restoration and patient's instructions PROCEDURE

The canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling.

Antimicrobial Corticosteroid mixture; Cryotherapy

Root canal obturation PROCEDURE

After the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation.

Antimicrobial Corticosteroid mixture; Cryotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant females.
• Patients with swelling.
• Patients whose tooth is non-restorable.
• Teeth with open apices.
• Teeth with radiographic evidence of root resorption.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Manial, 12613, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Carticaine; Epinephrine; Root Canal Preparation; Root Canal Obturation

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Root Canal Therapy; Endodontics; Dentistry; Tooth Preparation

Study Officials

• Maged M Negm, Professor in Endodontics

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both final irrigating solutions are colorless and will be delivered inside the root canal using a plastic syringe without the patient knowing the type of solution used. The microbial samples will be sent to the lab for microbial count assessment with a code without identification of the type of irrigating solution used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: February 22, 2023
• Study Start: July 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 9, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From 1/6/2024 - Forever
• Access Criteria: Anyone with the link can view the supporting information

Locations

EG (1)