CompletedNCT01496846ARTICUpdated Oct 31, 2017Results posted

Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars

A Phase 4 interventional study of IANB Articaine and SUP Articaine in Irreversible Pulpitis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by University of Michigan · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 201
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this trial is to study the ability of a frequently used dental anesthetic (articaine) to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique fails, a commonly used supplemental (SUP) technique with one of two possible dental anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness between the two anesthetics.

Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe.

The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits.

This study consisted of two periods of patient enrollment, treatment and data collection: Part I: 101 subjects; Part II: 100 subjects.

Read the detailed description

The goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars, either by IANB administration of 4% articaine with 1:100,000 epinephrine (NDA 022466), or in case the IANB appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine.

The proposed randomized controlled trial (RCT) aims to answer the following questions:

What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration?
Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB?
Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine?

This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size, giving a total sample size of approximately 200 patients.

Conditions studied

Irreversible Pulpitis

Browse trials for

Pulpitis 302

Keywords

Articaine
Lidocaine
Anesthesia, Local
Endodontics
Molar
Dental Pulp Diseases

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 201 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

adult patients
irreversible pulpitis in mandibular molar

Exclusion criteria

Exclusion Criteria:

below 18 years

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 201 participants (actual)

Study arms

Active comparator
IANB Articaine
IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.
Drug: IANB Articaine
Active comparator
SUP Articaine
SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.
Drug: IANB Articaine · Drug: SUP Articaine
Active comparator
SUP Lidocaine
SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
Drug: IANB Articaine · Drug: SUP Lidocaine

Interventions

DrugIANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
Also known as: Articadent (Dentsply Pharmaceutical)
DrugSUP Articaine
After unsuccessful IANB with articaine, proceed to give 1.7cc of 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).
Also known as: Articadent (Dentsply Pharmaceutical)
DrugSUP Lidocaine
After unsuccessful IANB with articaine, proceed to give 1.7cc of 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).
Also known as: Generic lidocaine (Henry Schein Inc)

What researchers measure

Primary outcomes

Anesthetic Success Rate of Supplemental Infiltration Injection
Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia
Time frame: 5 min after injection

Secondary outcomes

Anesthetic Success Rate of an IANB With Articaine
Success rate of an IANB with articaine using a conventional IANB technique
Time frame: 15 min after injection

Results

Posted Sep 13, 2017

Participant flow

Protocol enrollment: 201 subjects with 1 study tooth.

IANB Articaine (All Participants)

Participant flow — IANB Articaine (All Participants)
Milestone	IANB Articaine Only - 1st Molar	IANB Articaine Only - 2nd Molar	IANB Articaine and SUP Articaine - 1st Molar	IANB Articaine and SUP Articaine - 2nd Molar	IANB Articaine and SUP Lidocaine - 1st Molar	IANB Articaine and SUP Lidocaine - 2nd Molar
Started	28	24	36	40	35	38
Completed	27	23	36	40	35	38
Not completed	1	1	0	0	0	0
Withdrew: Inadequate lip numbness: "missed" block	1	1	0	0	0	0

Supplemental Buccal Infiltration

Participant flow — Supplemental Buccal Infiltration
Milestone	IANB Articaine and SUP Articaine - 1st Molar	IANB Articaine and SUP Articaine - 2nd Molar	IANB Articaine and SUP Lidocaine - 1st Molar	IANB Articaine and SUP Lidocaine - 2nd Molar
Started	36	40	35	38
Completed	36	40	35	38
Not completed	0	0	0	0

Outcome measures

PrimaryAnesthetic Success Rate of Supplemental Infiltration Injection

Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia

Time frame:: 5 min after injection
Reported as:: Count of participants · Participants

Anesthetic Success Rate of Supplemental Infiltration Injection
Participants	IANB Articaine and SUP Articaine - 1st Molar	IANB Articaine and SUP Articaine - 2nd Molar	IANB Articaine and SUP Lidocaine - 1st Molar	IANB Articaine and SUP Lidocaine - 2nd Molar
Anesthetic Success Rate of Supplemental Infiltration Injection	22	25	23	12

Statistical analysis

IANB Articaine and SUP Articaine - 1st Molar vs IANB Articaine and SUP Articaine - 2nd Molar · Chi-squared · p = .901We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.
IANB Articaine and SUP Lidocaine - 1st Molar vs IANB Articaine and SUP Lidocaine - 2nd Molar · Chi-squared · p = .004We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.

SecondaryAnesthetic Success Rate of an IANB With Articaine

Success rate of an IANB with articaine using a conventional IANB technique

Time frame:: 15 min after injection
Reported as:: Count of participants · Participants

Anesthetic Success Rate of an IANB With Articaine
Participants	IANB Articaine - 1st Molar	IANB Articaine - 2nd Molar
Anesthetic Success Rate of an IANB With Articaine	27	23

Statistical analysis

IANB Articaine - 1st Molar vs IANB Articaine - 2nd Molar · Chi-squared · p = .437We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.

Adverse events

Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Initial IANB Articaine	0/201 (0%)	0/201 (0%)	0/201 (0%)
SUP Articaine	0/76 (0%)	0/76 (0%)	0/76 (0%)
SUP Lidocaine	0/73 (0%)	0/73 (0%)	0/73 (0%)

Baseline characteristics

Overall number of participants include all enrolled subjects that received the initial IANB anesthesia.

Age, Continuous
Age, Continuous(years)	IANB Articaine Only - 1st Molar	IANB Articaine Only - 2nd Molar	IANB Articaine and SUP Articaine - 1st Molar	IANB Articaine and SUP Articaine - 2nd Molar	IANB Articaine and SUP Lidocaine - 1st Molar	IANB Articaine and SUP Lidocaine - 2nd Molar	Total
Mean	35 ± 11	50 ± 18	40 ± 14	38 ± 15	35 ± 14	40 ± 14	39 ± 15

Sex: Female, Male
Sex: Female, Male(Participants)	IANB Articaine Only - 1st Molar	IANB Articaine Only - 2nd Molar	IANB Articaine and SUP Articaine - 1st Molar	IANB Articaine and SUP Articaine - 2nd Molar	IANB Articaine and SUP Lidocaine - 1st Molar	IANB Articaine and SUP Lidocaine - 2nd Molar	Total
Female	13	13	12	23	22	19	102
Male	14	10	24	17	13	19	97

Region of Enrollment
Region of Enrollment(participants)	IANB Articaine Only - 1st Molar	IANB Articaine Only - 2nd Molar	IANB Articaine and SUP Articaine - 1st Molar	IANB Articaine and SUP Articaine - 2nd Molar	IANB Articaine and SUP Lidocaine - 1st Molar	IANB Articaine and SUP Lidocaine - 2nd Molar	Total
United States	27	24	36	40	35	38	199

Study locations

1 site

University of Michigan, School of Dentistry Clinics
Ann Arbor, Michigan 48109, United States

References and documents

Publications

Brandt RG, Anderson PF, McDonald NJ, Sohn W, Peters MC. The pulpal anesthetic efficacy of articaine versus lidocaine in dentistry: a meta-analysis. J Am Dent Assoc. 2011 May;142(5):493-504. doi: 10.14219/jada.archive.2011.0219. PubMed 21531931 ↗
Rogers BS, McDonald NJ, Gardner R, Botero T, Shlafer M, Peters MC. Anesthetic Efficacy of Articaine vs Lidocaine as Supplemental Infiltration after Unsuccessful IANB of Irreversible Pulpitis Mandibular Molars. AAE Annual Meeting. Honolulu, Hawaii, April 2013.
Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014 Jun;40(6):753-8. doi: 10.1016/j.joen.2013.12.022. Epub 2014 Feb 8. PubMed 24862701 ↗
Shapiro MR, McDonald NJ, Gardner RJ, Peters MC, Botero TM. Efficacy of Articaine versus Lidocaine in Supplemental Infiltration for Mandibular First versus Second Molars with Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Endod. 2018 Apr;44(4):523-528. doi: 10.1016/j.joen.2017.10.003. Epub 2018 Feb 1. PubMed 29397214 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01496846
Lead sponsor: University of Michigan
Collaborators: Dentsply International
Responsible party: Mathilde Peters, DMD, PhD (Principal Investigator, University of Michigan) — Principal investigator
First posted: Dec 21, 2011
Start date: Sep 2011
Primary completion: Feb 2016
Completion: Feb 2016
Results posted: Sep 13, 2017
Last update: Oct 31, 2017

Study contacts

Mathilde C Peters, DMD, PhD

study chair · University of Michigan

Tatiana Botero, DDS, MS

study director · University of Michigan

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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