Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Fructose

Diclofenac potassium

Diclofenac potassium 50 mg

Group Type EXPERIMENTAL

Diclofenac potassium

Intervention Type DRUG

Diclofenac potassium 50 mg granules for oral solution

Interventions

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Diclofenac potassium

Diclofenac potassium 50 mg granules for oral solution

Intervention Type DRUG

Placebo

Fructose

Intervention Type OTHER

Other Intervention Names

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Catafast-Novartis International AG, Basel, Switzerland

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No