The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

May 26, 2025 updated by: Summer Elsayed, British University In Egypt

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High concentration of diclofenac sodium
High concentration of diclofenac sodium mixed with saline
Drug: 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.
Active Comparator: Low concentration of diclofenac sodium
Low concentration of diclofenac sodium mixed with saline
Drug: 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.
Active Comparator: Calcium hydroxide
Calcium hydroxide paste form
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial count
Time Frame: On the seventh day from of intracanal medication placement appointment
Variation in bacterial count in high concentration of Diclofenac Sodium group compared by group of low concentration of Diclofenac Sodium group and calcium hydroxide group.
On the seventh day from of intracanal medication placement appointment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periapical healing
Time Frame: participants will be recalled after 6 months from the obturation for radiographic examination.

Change in the size of periapical lesion (according to Periapical index scale). The participants will be recalled after at least 6 months, and radiographic examination of the treated tooth will be performed. Preoperative and recall radiographs of teeth will be each assigned a Periapical index score by 2 blinded, independent, and calibrated examiners according to periapical index score (PAI):

PAI 1: Normal periapical structure. PAI 2: Bone structural changes indicating but not pathognomonic for apical periodontitis.

PAI 3: Bone structural changes with some mineral loss characteristic for apical periodontitis.

PAI 4: Well-defined apical radiolucency. PAI 5: Radiolucency with radiating expansion of bone structural changes.
participants will be recalled after 6 months from the obturation for radiographic examination.
incidence and intensity of pain
Time Frame: Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale
Patient will receive visual analogue scale (VAS) that will include a 10 cm line in which number 0 will correspond to no pain and number 10 will indicate unacceptable pain. Evaluation of intensity and incidence of pain, will be assessed each day for the following first three days after intracanal placement appointment (after 24 hours, 48 hours and 72 hours).
Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale
Incidence of flare-ups
Time Frame: Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).
Flare-up will be defined to patients as the development of swelling after treatment and will be represented by "Yes" (flare-up) or "No" (no flare-up). It will be recorded on chart that will given to the patients after the initial treatment.
Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British University In Egypt

Investigators

  • Study Director: Shehab Eldin M Saber, doctoral, british university in Egypt- dentistry collage

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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