The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

B

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

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

Trial contacts and locations

1

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Central trial contact

Summer M Elsayed, Bachelor

Data sourced from clinicaltrials.gov

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