Pain and Microbial Reduction of Antimicrobial Corticosteroid Mixture Versus Cryotherapy in Necrotic Teeth
NCT ID: NCT05739682
Last Updated: 2025-06-05
Study Results
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Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2024-07-01
2025-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
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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).
Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle
Tooth isolation
Rubber dam application to the affected tooth
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.
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.
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1 ml of levofloxacin will be withdrawn in a 3ml plastic syringe followed by 1 ml of fluconazole and 1 ml of dexamethasone sodium phosphate, the whole solution is then passively delivered into the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
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.
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.
Cryotherapy
Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle
Tooth isolation
Rubber dam application to the affected tooth
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.
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.
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.
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.
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.
Interventions
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Local anaesthetic injection of 4% articaine with 1:100000 epinephrine
Buccal infiltration injection using a side loading aspirating syringe and a 30-gauge needle
Tooth isolation
Rubber dam application to the affected tooth
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.
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.
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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with swelling.
3. Patients whose tooth is non-restorable.
4. Teeth with open apices.
5. Teeth with radiographic evidence of root resorption.
18 Years
50 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohammed Fawzy Omar Mohammed Habib
Principal investigator
Principal Investigators
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Maged M Negm, Professor in Endodontics
Role: STUDY_CHAIR
Cairo University
Locations
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Faculty of Dentistry, Cairo University
Cairo, Manial, Egypt
Countries
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Other Identifiers
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ENDO 18-11-21
Identifier Type: -
Identifier Source: org_study_id
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