The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207253
• Other study ID #: 23-039
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 2024
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: British University In Egypt
• Contact: Summer M Elsayed, Bachelor
• Phone: 01000095124
• Email: pg.summer92140015[@]bue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pulp Disease, Dental
• Stomatognathic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	British university in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Periapical healing	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.
Secondary	incidence and intensity of pain	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
Secondary	Incidence of flare-ups	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).