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Completed

NCT Number: NCT03146481

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cairo University

Cairo, 11553, Egypt

About this study

  • 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.
  • Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
  • Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
  • During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Aceclofenac

Drug

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

Other names: Bristaflam

Placebo

Other

Placebo tablet given one hour before starting the root canal treatment

Primary outcomes

  1. Anesthetic success

    Time frame: intraoperative

    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.

Secondary outcomes

  1. Pain on injection of inial IANB

    Time frame: intraoperative

    Pain on injection of inial IANB will be measured with Heft-Parker VAS

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Pre-operative Aceclofenac on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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