Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis
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|ClinicalTrials.gov Identifier: NCT03163420|
Recruitment Status : Unknown
Verified October 2016 by Aya Ahmed Youssef, Cairo University.
Recruitment status was: Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Irreversible Pulpitis||Drug: Diclofenac potassium Other: Placebo||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Pre-operative Diclofenac Potassium on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Cases With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
Placebo Comparator: Placebo
Experimental: Diclofenac potassium
Diclofenac potassium 50 mg
Drug: Diclofenac potassium
Diclofenac potassium 50 mg granules for oral solution
Other Name: Catafast-Novartis International AG, Basel, Switzerland
- anesthetic success [ Time Frame: Intraoperative ]Pain during treatment is measured using Heft Parker VAS
- Pain on injection of initial IANB [ Time Frame: Intraoperative ]measured using Heft Parker VAS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163420
|Faculty of Oral and dental medicine, Cairo University|
|Study Director:||Khaled M Ezzat, Professor||Faculty of Oral and Dental medicine, Cairo University|
|Study Chair:||Suzan AW Amin, PhD||Faculty of Oral and Dental medicine, Cairo University|