Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

Anesthesia, Local Clinical Trial

Official title:

Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174860
• Other study ID #: CEBC-CU-2016-11-167
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• Diclofenac Potassium 50mg Tab
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
• Placebo
A placebo will be taken one hour before initiation of endodontic treatment.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of articaine buccal infiltration.	Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.	Intraoperative
Secondary	Pain on injection	The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.	Intraoperative