Effect of Preoperative Diclofenac Potassium Dose on Endodontic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this trial
The aim of this study is to assess the effect of different doses of diclofenac potassium premedication (100mg vs 50mg) on anesthetic success of 4% articaine buccal infiltration and post-operative pain as compared to placebo in mandibular molars with symptomatic irreversible pulpitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with symptomatic irreversible pulpitis.
Patients with moderate to severe pain.
Mandibular molars
Patients with the ability to understand and use the pain scale
Disqualifiers
Patients allergic to any medication or material to be used in the study.
Pregnant and lactating females.
Patients taking medications affecting pain perception in the last 12 hours.
Patients having more than one symptomatic molar in the same quadrant.
Trial design
Design model
Parallel
Treatments tested in this trial
Diclofenac potassium 100mg
DrugPreoperative single dose of diclofenac potassium 100mg
Diclofenac potassium 50mg
DrugPreoperative single dose of diclofenac potassium 50mg
Placebo
DrugPreoperative placebo
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: 100mg Diclofenac potassiumExperimental treatment 1 intervention
Group B: 50mg Diclofenac potassiumActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anesthetic success of articaine buccal infiltration
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.
Time frame
During the treatmentSecondary outcomes
1
Postoperative pain at 6 hours
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Time frame
6 hours2
Postoperative pain at 12 hours
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Time frame
12 hours3
Postoperative pain at 24 hours
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Time frame
24 hours4
Postoperative pain at 48 hours
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Time frame
48 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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