Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

Phase 2

• Conditions: Irreversible Pulpitis
• Interventions: Other: Placebo; Drug: Diclofenac potassium

• Registration Number: NCT03163420
• Lead Sponsor: Cairo University

Brief Summary

The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Detailed Description

Objective: The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Design: Randomized double-blind controlled trial.

Setting and conduct:

* Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.

* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.

* Patients will be randomly assigned to one of 2 groups: experimental group (taking a 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated.

* During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered.

* Main outcome measures: Anesthetic success during root canal treatment using HP VAS.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-10
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-20
• Last Update Submitted: 2017-05-20
• Study First Posted: 2017-05-23
• Last Update Posted: 2017-05-23
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Patients in good health as determined by a medical history and oral questioning. (ASA I or II)
2. Age range is between 18 and 50 years.
3. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
4. Patients who can understand Heft Parker Visual Analogue Scales VAS.
5. Patients accepting to participate in the study and able to sign informed consent.

Exclusion Criteria

1. Pregnant female patient.
2. Patients allergic to diclofenac potassium or mepivacaine.
3. Patients having active pain in more than one mandibular molar.
4. Patients who had taken analgesics in the 12 hours preceding the injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Diclofenac potassium	Diclofenac potassium	Diclofenac potassium 50 mg

Primary Outcome Measures

Name	Time	Method
anesthetic success	Intraoperative	Pain during treatment is measured using Heft Parker VAS

Secondary Outcome Measures

Name	Time	Method
Pain on injection of initial IANB	Intraoperative	measured using Heft Parker VAS

Trial Locations

Locations (1)

Faculty of Oral and dental medicine, Cairo University; 🇪🇬 Cairo, Egypt