Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

NCT ID: NCT03174860

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-04-30

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.

Conditions

Pulpitis - Irreversible; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Diclofenac Potassium 50mg tab

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

Group Type: EXPERIMENTAL

Diclofenac Potassium 50mg Tab

Intervention Type: DRUG

A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.

Placebo

Placebo to be administered one hour before treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A placebo will be taken one hour before initiation of endodontic treatment.

Interventions

Diclofenac Potassium 50mg Tab

A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.

Intervention Type: DRUG

Placebo

A placebo will be taken one hour before initiation of endodontic treatment.

Intervention Type: DRUG

Other Intervention Names

Cataflam 50mg

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amatallah Hussein Nasser Al-Rawhani

Postgraduate Student in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amatallah H Al-Rawhani, Postgraduate

Role: PRINCIPAL_INVESTIGATOR

Faculty of Oral and Dental Medicine/ Cairo University.

Dr. Suzan AW Amin, PhD

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine/ Cairo University.

Shaima'a Gawdat, PhD

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine/ Cairo University.

Locations

Faculty of Dentistry

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24702239 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21692235 (View on PubMed)

Other Identifiers

CEBC-CU-2016-11-167

Identifier Type: -

Identifier Source: org_study_id