The Effect of Diclofenac Potassium Insitu Gel Vs Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect

Cairo University44 enrolled

Overview

The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post Operative Pain

Interventions

Diclofenac PotassiumDRUG

\- In the form of Insitu gel system can be applied as solution or suspension that undergoes gelation after administration. Applied once inside the root canal after chemo-mechanical preparation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18-45 years old. * Males/Females. * Lower permanent premolars with: Non-Vital pulps. Sensitive to percussion. Negative response to cold pulp tester (ethyl chloride spray1). Apical periodontitis * Systemically healthy patients (ASA I or II). Exclusion Criteria: * Medically compromised patients having significant systemic disorders. (ASA III or IV). * History of intolerance to NSAIDS. * Patients with two or more adjacent teeth requiring endodontic treatment. * Teeth with : * Association with swelling or fistulous tract. * Acute or chronic peri-apical abscess. Mobility Grade II or III. * Pocket depth more than 5mm. * Previous root canal therapy. * Non-restorability * Patients with a contraindication for the use of DFK or those known to be allergic to any of the study medications.eg. Patient with kidney problems.

Locations (1)

Faculty of Dentistry Cairo University

Cairo, El- Manial, Egypt

Outcomes

Primary Outcomes

Incidence of Post operative pain assessed by VAS

Post-operative pain following chemo-mechanical endodontic treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: * 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.

Time frame: 72 hours

Secondary Outcomes

Antibacterial effectiveness by measuring the bacterial count.

The bacterial count method will be used. Once the samples will arrive to the microbiology department, Cairo University, the tubes containing the thioglycolate 14(transport medium) with the paper points will be placed in micro centrifuge and vortexed for 30 sec. One hundred (100) μl aliquots of the vortexed samples will be placed in a new sterile tube containing 1 ml of thioglycolate to obtain 1/10 concentration to assess the microbial load of common aerobes and anaerobes found in each root canal. The effect of the treatment in each group, the initial colonizers (S1), the mechanical preparation (S2) and after the intra-canal medication (S3) will be compared.

Time frame: pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).

Central Contacts

Heba El Far, Professor

CONTACT

+201282006589 hebaelfar@hotmail.com

Dina Morsy, doctorate

CONTACT

+201223980157 dina.amorsy@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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