Dental Pulp NecrosisMIXCRYONCT05739682
Pain and Microbial Reduction of Antimicrobial Corticosteroid Mixture Versus Cryotherapy in Necrotic Teeth
A study testing Local anaesthetic injection of 4% articaine with 1:100000 epinephrine, Tooth isolation and Access cavity preparation in people with Dental Pulp Necrosis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- Local anaesthetic injection of 4% articaine with 1:100000 epinephrine, Tooth isolation and Access cavity preparation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 9 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Pregnant females.
- Patients with swelling.
- Patients whose tooth is non-restorable.
- Teeth with open apices.
- Teeth with radiographic evidence of root resorption.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- 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
- Keywords
- Antibiotic, Antifungal, Corticosteroid, Cryotherapy
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anaesthetic injection of 4% articaine with 1:100000 epinephrineProcedure or surgery
Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle
Tooth isolationProcedure or surgery
Rubber dam application to the affected tooth
Access cavity preparationProcedure or surgery
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.
Root canal shaping and cleaningProcedure or surgery
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.
Final irrigation with antimicrobial-corticosteroid mixtureProcedure or surgery
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
Final irrigation with cold salineProcedure or surgery
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.
Temporary restoration and patient's instructionsProcedure or surgery
The canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling.
Root canal obturationProcedure or surgery
After the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: At 48 hours after the 1st visit
Secondary outcomes (2)
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.
Measured: 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.
Measured: At 48 hours after the 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Jul 2024
- Primary completion30 Jan 2025
- Study completion9 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Fawzy Omar Mohammed Habib, Cairo University
- Investigators
- Maged M Negm, Professor in Endodontics, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739682
- Sponsor's protocol ID
- ENDO 18-11-21
- Acronym
- MIXCRYO
- Status last verified
- Feb 2025
- First submitted
- 18 Nov 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are planning to share individual patient's data regarding age, gender, preoperative pain score and outcome data
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05739682
- Acronym / sponsor ID
- MIXCRYO / ENDO 18-11-21
- Conditions
- Dental Pulp Necrosis
- Keywords
- Antibiotic, Antifungal, Corticosteroid, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Corticosteroid mixture | Experimental | 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 obturationEach 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). |
| Cryotherapy | Active comparator | 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 obturationEach canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- Pregnant females.
- Patients with swelling.
- Patients whose tooth is non-restorable.
- Teeth with open apices.
- Teeth with radiographic evidence of root resorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anaesthetic injection of 4% articaine with 1:100000 epinephrineBuccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle | Procedure or surgery | Antimicrobial Corticosteroid mixture, Cryotherapy |
| Tooth isolationRubber dam application to the affected tooth | Procedure or surgery | Antimicrobial Corticosteroid mixture, Cryotherapy |
| Access cavity preparationComplete 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 or surgery | Antimicrobial Corticosteroid mixture, Cryotherapy |
| Root canal shaping and cleaningWorking 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 or surgery | Antimicrobial Corticosteroid mixture, Cryotherapy |
| Final irrigation with antimicrobial-corticosteroid mixture1 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 or surgery | Antimicrobial Corticosteroid mixture |
| Final irrigation with cold salineFrozen 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 or surgery | Cryotherapy |
| Temporary restoration and patient's instructionsThe canals are dried using paper points and the access cavity is sealed using a non-eugenol temporary filling. | Procedure or surgery | Antimicrobial Corticosteroid mixture, Cryotherapy |
| Root canal obturationAfter the 1st visit by 3 days to 1 week, the patient is scheduled for a second appointment for root canal obturation. | Procedure or surgery | Antimicrobial Corticosteroid mixture, Cryotherapy |
Primary outcome
Postinstrumentation pain
Time frame: At 6 hours after the 1st visit
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
Time frame: At 12 hours after the 1st visit
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
Time frame: At 24 hours after the 1st visit
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
Time frame: At 48 hours after the 1st visit
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
2 secondary outcomes
Anti bacterial effect
Time frame: At 24 hours after the 1st visit
Antifungal effect
Time frame: At 48 hours after the 1st visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Yes. We are planning to share individual patient's data regarding age, gender, preoperative pain score and outcome data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maged M Negm, Professor in Endodontics study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anaesthetic injection of 4% articaine with 1:100000 epinephrine, Tooth isolation and Access cavity preparation in people with Dental Pulp Necrosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postinstrumentation pain (time frame: At 6 hours after the 1st visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.