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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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Post Operative Pain

Treatments

Drug: Diclofenac Potassium

Study type

Interventional

Funder types

Other

Identifiers

NCT04622488
ENDO 3-7-2

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups

Diclofenac Potassium
Active Comparator group
Description:
In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration.
Treatment:
Drug: Diclofenac Potassium
Calcium Hydroxide
Experimental group
Treatment:
Drug: Diclofenac Potassium

Trial contacts and locations

1

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Central trial contact

Heba El Far, Professor; Dina Morsy, doctorate

Data sourced from clinicaltrials.gov

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