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

NCT ID: NCT01574807

Last Updated: 2020-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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One hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of; 1.) an injection of 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and 2.) an injection of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, at two separate appointments spaced at least two weeks apart, in a crossover design. Whether the subject receives the mepivacaine or the lidocaine for the first injection will be determined randomly. The doctor will not know whether the subject receives mepivacaine or lidocaine for the first injection. The subject will not know which anesthetics he/she receives. A 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. The data will be statistically analyzed.

Conditions

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Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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mepivacaine + lidocaine followed by lidocaine + lidocaine

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.

Group Type EXPERIMENTAL

mepivacaine + lidocaine followed by lidocaine +lidocaine

Intervention Type 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

lidocaine + lidocaine followed by mepivacaine plus lidocaine

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.

Group Type EXPERIMENTAL

lidocaine + lidocaine followed by mepivacaine + lidocaine

Intervention Type 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

Interventions

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mepivacaine + lidocaine followed by lidocaine +lidocaine

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

Intervention Type DRUG

lidocaine + lidocaine followed by mepivacaine + lidocaine

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

Intervention Type DRUG

Other Intervention Names

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Combo 1 Combo 2

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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John Nusstein

Associate Professor and Chair, Divison of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Nusstein, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Chair, Division of Endodontics

Locations

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The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12640855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8509754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8245762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7024357 (View on PubMed)

Other Identifiers

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Endo-Lam2012

Identifier Type: -

Identifier Source: org_study_id