Clinical trial

The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial

Name
23-039
Description
The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The main question\[s\] it aims to answer are: • Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-02-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Diclofenac Sodium
placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
Arms:
High concentration of diclofenac sodium, Low concentration of diclofenac sodium
Calcium hydroxide
placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
Arms:
Calcium hydroxide
Size
48
Primary endpoint
Bacterial count
On the seventh day from of intracanal medication placement appointment
Eligibility criteria
Inclusion Criteria: * Patients with teeth diagnosed with apical periodontitis * Periapical Index (PAI) ≥ 2 * The teeth are restorable Exclusion Criteria: * Teeth with immature roots * Non restorable teeth * Medically compromised patients with systemic complication that would alter the treatment. * Teeth with internal/external root resorption * Patient with an allergy to diclofenac sodium
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2024-01-17

1 organization

2 products

4 indications

Product
Diclofenac
Indication
Pulp Disease
Indication
Toothache