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

Primary Purpose

Dental Pulp Necrosis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
Tooth isolation
Access cavity preparation
Root canal shaping and cleaning
Final irrigation with antimicrobial-corticosteroid mixture
Final irrigation with cold saline
Temporary restoration and patient's instructions
Root canal obturation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Necrosis focused on measuring Antibiotic, Antifungal, Corticosteroid, Cryotherapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: Pregnant females. Patients with swelling. Patients whose tooth is non-restorable. Teeth with open apices. Teeth with radiographic evidence of root resorption.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Antimicrobial Corticosteroid mixture

    Cryotherapy

    Arm Description

    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).

    Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    November 18, 2021
    Last Updated
    February 13, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05739682
    Brief Title
    Pain and Microbial Reduction of Antimicrobial Corticosteroid Mixture Versus Cryotherapy in Necrotic Teeth
    Acronym
    MIXCRYO
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pulp Necrosis
    Keywords
    Antibiotic, Antifungal, Corticosteroid, Cryotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Antimicrobial Corticosteroid mixture
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Cryotherapy
    Arm Type
    Active Comparator
    Arm Description
    Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
    Intervention Description
    Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth isolation
    Intervention Description
    Rubber dam application to the affected tooth
    Intervention Type
    Procedure
    Intervention Name(s)
    Access cavity preparation
    Intervention 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
    Intervention Name(s)
    Root canal shaping and cleaning
    Intervention 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
    Intervention Name(s)
    Final irrigation with antimicrobial-corticosteroid mixture
    Intervention 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
    Intervention Name(s)
    Final irrigation with cold saline
    Intervention 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
    Intervention Name(s)
    Temporary restoration and patient's instructions
    Intervention Description
    The canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling.
    Intervention Type
    Procedure
    Intervention Name(s)
    Root canal obturation
    Intervention Description
    After the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation.
    Primary Outcome Measure Information:
    Title
    Postinstrumentation pain
    Description
    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
    Time Frame
    At 6 hours after the 1st visit
    Title
    Postinstrumentation pain
    Description
    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
    Time Frame
    At 12 hours after the 1st visit
    Title
    Postinstrumentation pain
    Description
    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
    Time Frame
    At 24 hours after the 1st visit
    Title
    Postinstrumentation pain
    Description
    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
    Time Frame
    At 48 hours after the 1st visit
    Secondary Outcome Measure Information:
    Title
    Anti bacterial effect
    Description
    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.
    Time Frame
    At 24 hours after the 1st visit
    Title
    Antifungal effect
    Description
    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.
    Time Frame
    At 48 hours after the 1st visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: Pregnant females. Patients with swelling. Patients whose tooth is non-restorable. Teeth with open apices. Teeth with radiographic evidence of root resorption.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 URL
    https://drive.google.com/drive/folders/11vjiC0a6uQFZXT8EdRE7b0rfweak2GRk

    Learn more about this trial

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

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