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

Not Applicable

Not yet recruiting

• Conditions: Dental Pulp Necrosis
• Interventions: Procedure: Tooth isolation; Procedure: Access cavity preparation; Procedure: Root canal shaping and cleaning; Procedure: Final irrigation with antimicrobial-corticosteroid mixture; Procedure: Final irrigation with cold saline; Procedure: Temporary restoration and patient's instructions; Procedure: Root canal obturation

• Registration Number: NCT05739682
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14
• Study Start: 2024-05-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antimicrobial Corticosteroid mixture	Tooth isolation	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).
Cryotherapy	Access cavity preparation	Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
Cryotherapy	Tooth isolation	Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
Cryotherapy	Root canal shaping and cleaning	Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
Cryotherapy	Root canal obturation	Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
Antimicrobial Corticosteroid mixture	Access cavity preparation	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).
Antimicrobial Corticosteroid mixture	Root canal shaping and cleaning	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).
Antimicrobial Corticosteroid mixture	Final irrigation with 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).
Antimicrobial Corticosteroid mixture	Temporary restoration and patient's instructions	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).
Cryotherapy	Final irrigation with cold saline	Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.
Antimicrobial Corticosteroid mixture	Root canal obturation	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).
Cryotherapy	Temporary restoration and patient's instructions	Each canal will receive final irrigation with 20ml of cold saline (2.5°c) for 5 minutes.

Primary Outcome Measures

Name	Time	Method
Postinstrumentation pain	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

Secondary Outcome Measures

Name	Time	Method
Anti bacterial effect	At 24 hours after the 1st visit	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	At 48 hours after the 1st visit	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.