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

NCT ID: NCT04622488

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Pain

Keywords

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Calcium Hydroxide Diclofenac potassium Intra-canal Medications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac Potassium

In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration.

Group Type ACTIVE_COMPARATOR

Diclofenac Potassium

Intervention Type DRUG

\- 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.

Calcium Hydroxide

Group Type EXPERIMENTAL

Diclofenac Potassium

Intervention Type DRUG

\- 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.

Interventions

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Diclofenac Potassium

\- 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.

Intervention Type DRUG

Other Intervention Names

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Cataflam

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Salma Mohamed Aboul Azayem

Prinicipal Investegator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry Cairo University

Cairo, El- Manial, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Heba El Far, Professor

Role: CONTACT

Phone: +201282006589

Email: [email protected]

Dina Morsy, doctorate

Role: CONTACT

Phone: +201223980157

Email: [email protected]

Facility Contacts

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Heba El Far, Professor

Role: primary

Dina Morsy, Doctorate

Role: backup

Other Identifiers

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ENDO 3-7-2

Identifier Type: -

Identifier Source: org_study_id