Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine

Symptomatic Irreversible Pulpitis Clinical Trial

— Anesthesia  

Official title:

Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine for Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial PART 6

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03725579
• Other study ID #: CEBD-CU-2014-06-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 15, 2018
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: Marwa M Bedier, PHD
• Phone: 0021006611104
• Email: m.bedier81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective randomized clinical trial was compare between 2% Mepivacaine and 4% Articaine for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis in mandibular molars as regards to their anesthetic efficiency; during access cavity preparation and instrumentation.

Description:

Sixty-six patients diagnosed clinically and radiographically with symptomatic irreversible pulpitis in mandibular posterior teeth will received single-visit root canal treatment using ProTaper Universal rotary system for canal preparation, then they will be randomly divided into two groups (n=33) according to the anesthetic solution used, either Group M (3.6 ml Mepivacaine hydrochloride 2% with 1:100000 epinephrine) or Group A (3.4 ml Articaine hydrochloride 4% with 1:100000 epinephrine). The pain will be assessed using numerical rating scale (NRS) during access cavity preparation and instrumentation, then the need for supplemental anesthesia will be also recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients in good health (American Society of Anesthesiologists Class II or higher)

2. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.

3. Age range is between 20 and 50 years.

4. Patients who can understand Visual Analogue Scales VAS.

5. Patients able to sign informed consent

Exclusion Criteria:

1. Patients allergic to articaine and/or mepivacaine and/or sulfur

2. Patients having active sites of pathosis in the area of injection.

3. Patients having active pain in more than one molar.

4. Patients who had taken analgesics in the 12 hours preceding the injection.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Drug:
• mepivicane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation
• articane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity: Numerical rating scale (NRS)	Pain intensity during access cavity preparation using numerical rating scale (NRS). The scale was numerical to facilitate its use by the participants. The Numerical rating scale is an 10-point scale anchored by two extremes "No pain" and "pain as bad as it could be".; Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10].	Fifteen minutes after injection of the anaesthetic solution
Secondary	Pain intensity: Numerical rating scale (NRS)	Pain intensity during root canal negotiation and instrumentation using Numerical rating scale is an 10-point scale anchored by two extremes "No pain" and "pain as bad as it could be".; Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10].	Twenty-five minutes after injection of the anaesthetic solution
Secondary	The number of patients who need suplemental anesthesia	counting the number of the number of patients who need suplemental anesthesia	Fifteen minutes after injection of the anaesthetic solution