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Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

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Sponsor
Cairo University

Parole chiave

Astratto

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.

Descrizione

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.

Date

Ultimo verificato: 06/30/2018
Primo inviato: 05/08/2017
Iscrizione stimata inviata: 05/30/2017
Primo pubblicato: 06/04/2017
Ultimo aggiornamento inviato: 07/17/2018
Ultimo aggiornamento pubblicato: 07/18/2018
Data di inizio effettiva dello studio: 09/30/2016
Data di completamento primaria stimata: 01/31/2018
Data stimata di completamento dello studio: 03/31/2018

Condizione o malattia

Pulpitis - Irreversible
Anesthesia, Local

Intervento / trattamento

Drug: Diclofenac Potassium 50mg tab

Drug: Placebo

Fase

Fase 2/Fase 3

Gruppi di braccia

BraccioIntervento / trattamento
Experimental: Diclofenac Potassium 50mg tab
Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment.
Drug: Diclofenac Potassium 50mg tab
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
Placebo Comparator: Placebo
Placebo to be administered one hour before treatment.
Drug: Placebo
A placebo will be taken one hour before initiation of endodontic treatment.

Criteri di idoneità

Età idonea per lo studio 18 Years Per 18 Years
Sessi idonei allo studioAll
Accetta volontari sani
Criteri

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.

Risultato

Misure di esito primarie

1. Success of articaine buccal infiltration. [Intraoperative]

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.

Misure di esito secondarie

1. Pain on injection [Intraoperative]

The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.

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