The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

NCT ID: NCT06207253

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endodontic Disease Pulp Disease, Dental Intracanal Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High concentration of diclofenac sodium

High concentration of diclofenac sodium mixed with saline

Group Type EXPERIMENTAL

Diclofenac Sodium

Intervention Type DRUG

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.

Low concentration of diclofenac sodium

Low concentration of diclofenac sodium mixed with saline

Group Type ACTIVE_COMPARATOR

Diclofenac Sodium

Intervention Type DRUG

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.

Calcium hydroxide

Calcium hydroxide paste form

Group Type ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Summer Elsayed

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shehab Eldin M Saber, doctoral

Role: STUDY_DIRECTOR

british university in Egypt- dentistry collage

Locations

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British university in Egypt

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Summer M Elsayed, Bachelor

Role: CONTACT

01000095124

Facility Contacts

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Summer M Elsayed, Bachelor

Role: primary

01000095124

Other Identifiers

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23-039

Identifier Type: -

Identifier Source: org_study_id

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