The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

NCT06207253 | Recruiting Phase 2

• 1 other identifier: 23-039
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endodontic Disease; Pulp Disease, Dental; Intracanal Medication

Keywords

Sodium diclofenac; Intracanal medication; Calcium hydroxide; Apical periodontitis

Outcome Measures

Primary Outcomes (1)

• Bacterial count

  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 Outcomes (3)

• Periapical healing

  participants will be recalled after 6 months from the obturation for radiographic examination.

• incidence and intensity of pain

  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

  Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).

Study Arms (3)

High concentration of diclofenac sodium

EXPERIMENTAL

High concentration of diclofenac sodium mixed with saline

Drug: Diclofenac Sodium

Low concentration of diclofenac sodium

ACTIVE COMPARATOR

Low concentration of diclofenac sodium mixed with saline

Drug: Diclofenac Sodium

Calcium hydroxide

ACTIVE COMPARATOR

Calcium hydroxide paste form

Drug: Calcium hydroxide

Interventions

Diclofenac Sodium 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.

High concentration of diclofenac sodium; Low concentration of diclofenac sodium

Calcium hydroxide 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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with teeth diagnosed with apical periodontitis
• Periapical Index (PAI) ≥ 2
• The teeth are restorable

You may not qualify if:

• 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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British university in Egypt

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases; Periapical Periodontitis

Interventions

Diclofenac; Calcium Hydroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Shehab Eldin M Saber, doctoral

  british university in Egypt- dentistry collage

  STUDY DIRECTOR

Central Study Contacts

Summer M Elsayed, Bachelor

CONTACT

01000095124; pg.summer92140015@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 16, 2024
• Study Start: November 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)