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

Cairo University (CU)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Irreversible Pulpitis

Treatments

Drug: Aceclofenac

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03146481

CEBD-CU-2015-5-145

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.