The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

British University In Egypt

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Intracanal Medication; Pulp Disease, Dental; Endodontic Disease

Treatments: Drug: Diclofenac Sodium; Drug: Calcium hydroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT06207253

23-039

Details and patient eligibility

About

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.

Full description

The aim of the present study 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 evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups

High concentration of diclofenac sodium

Experimental group

Description:

High concentration of diclofenac sodium mixed with saline

Treatment:

Drug: Diclofenac Sodium

Low concentration of diclofenac sodium

Active Comparator group

Description:

Low concentration of diclofenac sodium mixed with saline

Treatment:

Drug: Diclofenac Sodium

Calcium hydroxide

Active Comparator group

Description:

Calcium hydroxide paste form

Treatment:

Drug: Calcium hydroxide