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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03146481

Enrollment

Registered

2017-05-10

Start date

2016-07-31

Completion date

2017-07-31

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

Anesthetic efficacy, Irriversible pulpitis, Aceclofenac

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.

Detailed description

* 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.

Interventions

DRUGAceclofenac

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

OTHERPlacebo

Placebo tablet given one hour before starting the root canal treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Anesthetic success	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

Measure	Time frame	Description
Pain on injection of inial IANB	intraoperative	Pain on injection of inial IANB will be measured with Heft-Parker VAS

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026