Symptomatic Irreversible Pulpitis
Conditions
Brief summary
The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.
Detailed description
Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.
Interventions
DRUGDiclofenac potassium- acetaminophen combination
Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
Preoperative single dose of diclofenac potassium(50mg)
DRUGPlacebo
Preoperative single dose of placebo
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic irreversible pulpitis with/without mechanical allodynia * Patients with moderato to severe spontaneous pain * Mandibular molars * Patients with the ability to understand and use the pain scale * Patients accepting enrollment in the study
Exclusion criteria
* 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 * Patients with contributory medical history (ASA \> II)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthetic success of inferior alveolar nerve block | During the treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain at 12 hours | 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 |
| Postoperative pain at 24 hours | 24 hours | 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 |
| Postoperative pain at 6 hours | 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 |
| Postoperative pain at 72 hours | 72 hours | 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 |
| Postoperative pain at 7 days | 7 days | 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 |
| Postoperative pain at 48 hours | 48 hours | 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 |
Contacts
Primary ContactSovana T. Abd El-Monem
Backup ContactSuzan Amin
Outcome results
None listed