The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections

NCT01574807 | Completed Phase 4 Results

• 1 other identifier: Endo-Lam2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The inferior alveolar nerve block (shot) is the most frequently used injection technique for achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of injection (shot). The investigators propose to compare an injection of mepivacaine followed by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a difference in effectiveness.

Conditions

Pain

Keywords

mepivacaine; lidocaine; inferior alveolar nerve block; pulpal anesthesia; mepivacaine/lidocaine; lidocaine/lidocaine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Pulpal Anesthesia Success.

  An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.

  60 minutes per injection sequence.

Study Arms (2)

mepivacaine + lidocaine followed by lidocaine + lidocaine

EXPERIMENTAL

A repeated measures design utilizing a single group of subjects was employed with each subject serving as his/her own control. Each subject received two interventions: 1.) 1.8 cc 3% mepivacaine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine (3% mepivacaine/2% lidocaine with epinephrine - combination 1) and 2.) 1.8 cc 2% lidocaine with 1:100,000 epinephrine followed by 1.8 cc 2% liocaine with 1:100,000 epinephrine at two seperate appointments spaced 2 weeks apart.

Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine

lidocaine + lidocaine followed by mepivacaine plus lidocaine

EXPERIMENTAL

A repeated measures design utilizing a single group of subjects was employed with each subject serving as his/her own control. Each subject received two interventions: 1.) 1.8 cc 2% lidocaine with 1:100,000 epinephrine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine and 2.) 1.8 cc 3% mepivacaine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine followed by 1.8 cc 2% liocaine with 1:100,000 epinephrine at two separate appointments spaced two weeks apart.

Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine

Interventions

mepivacaine + lidocaine followed by lidocaine +lidocaine DRUG

1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine

Also known as: Combo 1

mepivacaine + lidocaine followed by lidocaine + lidocaine

lidocaine + lidocaine followed by mepivacaine + lidocaine DRUG

1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine

Also known as: Combo 2

lidocaine + lidocaine followed by mepivacaine plus lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18 and 65 years
• good health (ASA classification I or II)
• able to provide informed consent

You may not qualify if:

• allergy to lidocaine or mepivacaine
• history of significant medical problem (ASA classification III or greater)
• depression
• have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours
• lactating or pregnant
• inability to give informed consent

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

• Nusstein J, Reader A, Beck FM. Anesthetic efficacy of different volumes of lidocaine with epinephrine for inferior alveolar nerve blocks. Gen Dent. 2002 Jul-Aug;50(4):372-5; quiz 376-7.

  PMID: 12640855 BACKGROUND

• McLean C, Reader A, Beck M, Meryers WJ. An evaluation of 4% prilocaine and 3% mepivacaine compared with 2% lidocaine (1:100,000 epinephrine) for inferior alveolar nerve block. J Endod. 1993 Mar;19(3):146-50. doi: 10.1016/s0099-2399(06)80510-8.

  PMID: 8509754 BACKGROUND

• Cohen HP, Cha BY, Spangberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3. doi: 10.1016/S0099-2399(06)81366-X.

  PMID: 8245762 BACKGROUND

• Rood JP, Caruana PE, Danford M, Pateromichelakis S. Prilocaine -- an investigation into its use in the presence of inflammation and in combination with lignocaine. J Dent. 1981 Sep;9(3):240-7. doi: 10.1016/0300-5712(81)90061-0. No abstract available.

  PMID: 7024357 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Mepivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. John Nusstein
• Organization: Division of Endodontics

nusstein.1@osu.ed

614-292-3596

Study Officials

• John Nusstein, DDS, MS

  Chair, Division of Endodontics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair, Divison of Endodontics

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-11

Locations

US (1)