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

Cairo University (CU)

Status: Completed

Conditions: Dental Pulp Necrosis

Treatments: Procedure: Final irrigation with antimicrobial-corticosteroid mixture; Procedure: Root canal obturation; Procedure: Final irrigation with cold saline; Procedure: Local anaesthetic injection of 4% articaine with 1:100000 epinephrine; Procedure: Root canal shaping and cleaning; Procedure: Tooth isolation; Procedure: Temporary restoration and patient's instructions; Procedure: Access cavity preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT05739682

ENDO 18-11-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Antimicrobial Corticosteroid mixture

Experimental group

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).

Treatment:

Procedure: Temporary restoration and patient's instructions

Procedure: Access cavity preparation

Procedure: Root canal shaping and cleaning

Procedure: Tooth isolation

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

Procedure: Root canal obturation

Procedure: Final irrigation with antimicrobial-corticosteroid mixture

Cryotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Temporary restoration and patient's instructions

Procedure: Access cavity preparation

Procedure: Root canal shaping and cleaning

Procedure: Tooth isolation

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

Procedure: Root canal obturation

Procedure: Final irrigation with cold saline