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

Phase 2

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Other: Placebo; Drug: Aceclofenac

• Registration Number: NCT03146481
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-04
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo
Aceclofenac	Aceclofenac	Aceclofenac 100 mg tablet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pain on injection of inial IANB	intraoperative	Pain on injection of inial IANB will be measured with Heft-Parker VAS

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt