Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis

NCT03146481 | Completed Phase 2

• 1 other identifier: CEBD-CU-2015-5-145
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.

Conditions

Irreversible Pulpitis

Keywords

Anesthetic efficacy, Irriversible pulpitis, Aceclofenac

Outcome Measures

Primary Outcomes (1)

• Anesthetic success

  Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation which will be measured with Heft-parker VAS in which no or mild pain will be considered as anesthetic success and moderate or severe pain will be considered as anesthetic failure.

  intraoperative

Secondary Outcomes (1)

• Pain on injection of inial IANB

  intraoperative

Study Arms (2)

Aceclofenac

EXPERIMENTAL

Aceclofenac 100 mg tablet

Drug: Aceclofenac

placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Aceclofenac DRUG

Aceclofenac 100 mg tablet given one hour before starting the root canal treatment

Also known as: Bristaflam

Aceclofenac

Placebo OTHER

Placebo tablet given one hour before starting the root canal treatment

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in good health (American Society of Anesthesiologists Class I or Class II).
• Patients having symptomatic irreversible pulpitis in one of their mandibular molars
• Age is 18 years or older.
• Patients who can understand Heft- Parker Visual Analogue Scales.
• Patients able to sign informed consent.

You may not qualify if:

• Patients allergic to aceclofenac or Mepivacaine.
• Pregnant or nursing women.
• Patients having active pain in more than one molar in the same quadrant.
• Administration of analgesics within 12 h before the administration of the study drug.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11553, Egypt

Location

Related Publications (2)

• Ramachandran A, Khan SI, Mohanavelu D, Kumar KS. The efficacy of pre-operative oral medication of paracetamol, ibuprofen, and aceclofenac on the success of maxillary infiltration anesthesia in patients with irreversible pulpitis: A double-blind, randomized controlled clinical trial. J Conserv Dent. 2012 Oct;15(4):310-4. doi: 10.4103/0972-0707.101881.

  PMID: 23112474 BACKGROUND

• Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.

  PMID: 23716973 BACKGROUND

MeSH Terms

Interventions

aceclofenac

Study Officials

• Nermeen A Abbas, Postgraduate

  Cairo University

  PRINCIPAL INVESTIGATOR

• Suzan AW Amin, PhD

  Cairo University

  STUDY DIRECTOR

• Shaimaa Gawdat, PhD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cairo University

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)