Clinical trial NCT05739682: Pain and Microbial Reduction of Antimicrobial Corticosteroid Mixture Versus Cryotherapy in Necrotic Teeth
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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Necrosis
Keywords: Antibiotic
Antifungal
Corticosteroid
Cryotherapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postinstrumentation pain
timeFrame: At 6 hours after the 1st visit
measure: Postinstrumentation pain
timeFrame: At 12 hours after the 1st visit
measure: Postinstrumentation pain
timeFrame: At 24 hours after the 1st visit
measure: Postinstrumentation pain
timeFrame: At 48 hours after the 1st visit
Secondary outcomes:
measure: Anti bacterial effect
timeFrame: At 24 hours after the 1st visit
measure: Antifungal effect
timeFrame: At 48 hours after the 1st visit
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Maged M Negm, Professor in Endodontics
role: STUDY_CHAIR
References: