Clinical trial NCT06207253: The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament
Official title: The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Endodontic Disease
Pulp Disease, Dental
Intracanal Medication
Keywords: Sodium diclofenac
Intracanal medication
Calcium hydroxide
Apical periodontitis
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacterial count
timeFrame: On the seventh day from of intracanal medication placement appointment
Secondary outcomes:
measure: Periapical healing
timeFrame: participants will be recalled after 6 months from the obturation for radiographic examination.
measure: incidence and intensity of pain
timeFrame: Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale
measure: Incidence of flare-ups
timeFrame: Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British university in Egypt
Study officials:
affiliation: british university in Egypt- dentistry collage
name: Shehab Eldin M Saber, doctoral
role: STUDY_DIRECTOR
References: