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Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

NCT ID: NCT04593160

Last Updated: 2020-10-30

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

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-03-31

Brief Summary

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The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.

Detailed Description

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Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac potassium- acetaminophen combination

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Group Type EXPERIMENTAL

Diclofenac potassium- acetaminophen combination

Intervention Type DRUG

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Diclofenac potassium

Preoperative single dose of diclofenac potassium(50mg)

Group Type EXPERIMENTAL

Diclofenac potassium

Intervention Type DRUG

Preoperative single dose of diclofenac potassium(50mg)

Placebo

Preoperative single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Preoperative single dose of placebo

Interventions

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Diclofenac potassium- acetaminophen combination

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Intervention Type DRUG

Diclofenac potassium

Preoperative single dose of diclofenac potassium(50mg)

Intervention Type DRUG

Placebo

Preoperative single dose of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
* Patients with moderato to severe spontaneous pain
* Mandibular molars
* Patients with the ability to understand and use the pain scale
* Patients accepting enrollment in the study

Exclusion Criteria

* Patients allergic to any medication or material to be used in the study
* Pregnant and lactating females
* Patients taking medications affecting pain perception in the last 12 hours
* Patients having more than one symptomatic molar in the same quadrant
* Patients with contributory medical history (ASA \> II)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sovana Tarek

Postgraduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sovana T. Abd El-Monem

Role: CONTACT

Phone: +201005173697

Email: [email protected]

Suzan Amin

Role: CONTACT

Email: [email protected]

References

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Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.

Reference Type BACKGROUND
PMID: 29709297 (View on PubMed)

Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.

Reference Type BACKGROUND
PMID: 17185119 (View on PubMed)

Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26.

Reference Type BACKGROUND
PMID: 32470370 (View on PubMed)

Other Identifiers

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CU-ENDO-6-10-2020.

Identifier Type: -

Identifier Source: org_study_id