The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diclofenac Sodium, Calcium hydroxide.
- Who it may be relevant to
- Registry conditions: Endodontic Disease, Pulp Disease, Dental, Intracanal Medication. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Bacterial count [Time frame: On the seventh day from of intracanal medication placement appointment]
Secondary outcome measures (3)
- Periapical healing [Time frame: 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]
- 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).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- British university in Egypt — Cairo
Identifiers
NCT: NCT06207253 · 23-039