NCT04622488

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

October 28, 2020

Last Update Submit

November 3, 2020

Conditions

Post Operative Pain

Keywords

Calcium HydroxideDiclofenac potassiumIntra-canal Medications

Outcome Measures

Primary Outcomes (1)

  • 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.

    72 hours

Secondary Outcomes (1)

  • Antibacterial effectiveness by measuring the bacterial count.

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

Study Arms (2)

Diclofenac Potassium

ACTIVE COMPARATOR

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

Drug: Diclofenac Potassium

Calcium Hydroxide

EXPERIMENTAL
Drug: Diclofenac Potassium

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.

Also known as: Cataflam
Calcium HydroxideDiclofenac Potassium

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, El- Manial, 11553, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Heba El Far, Professor

CONTACT

+201282006589hebaelfar@hotmail.com

Dina Morsy, doctorate

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investegator

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 10, 2020

Study Start

November 1, 2020

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

November 10, 2020

Record last verified: 2020-10

Locations

EG(1)