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

Irreversible Pulpitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146481
• Other study ID #: CEBD-CU-2015-5-145
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 7, 2017
• Last updated: November 4, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

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

Other:
• Placebo
Placebo tablet given one hour before starting the root canal treatment

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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