Clinical trial NCT03174860: Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success
Official title: Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulpitis - Irreversible
Anesthesia, Local
Keywords: Pulpitis, irreversible Pulpitis, Hot tooth
Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic
Local anesthesia, Articaine, Buccal infiltration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly divided into 2 groups:

Experimental group:

Diclofenac Potassium (50 mg, Cataflam) to be administered one hour before treatment.

Control group:

Placebo to be administered one hour before treatment.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.

Detailed description: This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.

Eligibility criteria: Inclusion Criteria:

* Patients with active pain (moderate-to-severe) in mandibular molars.
* Patients with prolonged response to cold testing and electric pulp tester.
* Patient with the ability to understand and use pain scales.
* Patient with vital coronal pulp tissue on access.
* Patient who accept to enroll to the study.

Exclusion Criteria:

* Patients' allergies or any other contraindication to diclofenac potassium or articaine.
* Pregnant and lactating females.
* Patients having pain medication in the last 6 hours.
* Patient has more than one symptomatic mandibular tooth in the same quadrant.
* Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
* Patients with active peptic ulcer and gastrointestinal disorders.
* Patients with history of bleeding problems or anticoagulant use within the last month.

Primary outcomes:
measure: Success of articaine buccal infiltration.
timeFrame: Intraoperative
Secondary outcomes:
measure: Pain on injection
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Faculty of Oral and Dental Medicine/ Cairo University.
name: Amatallah H Al-Rawhani, Postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Oral and Dental Medicine/ Cairo University.
name: Dr. Suzan AW Amin, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Oral and Dental Medicine/ Cairo University.
name: Shaima'a Gawdat, PhD
role: STUDY_DIRECTOR
References:
citation: Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
citation: Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.