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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00049692 | Other Identifier | U-Michigan | |
| HUM00088384 | Other Identifier | U-Michigan |
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| Name | Class |
|---|---|
| Dentsply International | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IANB Articaine | Active Comparator | IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic. |
|
| SUP Articaine | Active Comparator | SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB. |
|
| SUP Lidocaine | Active Comparator | SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IANB Articaine | Drug | IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthetic Success Rate of an IANB With Articaine | Success rate of an IANB with articaine using a conventional IANB technique | 15 min after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde C Peters, DMD, PhD | University of Michigan | Study Chair |
| Tatiana Botero, DDS, MS | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, School of Dentistry Clinics | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21531931 | Background | 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. | |
| Result | 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. | ||
| 24862701 |
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All enrolled study participants (N=201) initially received an Articaine inferior alveolar nerve block (IANB).
If unsuccessful (N=149), this was followed by a supplemental dose (SUP) of either Articaine or Lidocaine.
Fifty-two subjects were excluded prior to assignment to groups due to inadequate lip numbness (N=2) or successful IANB (N=50).
Protocol enrollment: 201 subjects with 1 study tooth.
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| ID | Title | Description |
|---|---|---|
| FG000 | IANB Articaine Only - 1st Molar | IANB anesthesia with articaine local anesthetic provided to 1st Molar. |
| FG001 | IANB Articaine Only - 2nd Molar | IANB anesthesia with articaine local anesthetic provided to 2nd Molar. |
| FG002 | IANB Articaine and SUP Articaine - 1st Molar | Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB. |
| FG003 | IANB Articaine and SUP Articaine - 2nd Molar | Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB. |
| FG004 | IANB Articaine and SUP Lidocaine - 1st Molar | Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB. |
| FG005 | IANB Articaine and SUP Lidocaine - 2nd Molar | Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IANB Articaine (All Participants) |
|
| ||||||||||||||||||
| Supplemental Buccal Infiltration |
|
Overall number of participants include all enrolled subjects that received the initial IANB anesthesia.
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| ID | Title | Description |
|---|---|---|
| BG000 | IANB Articaine Only - 1st Molar | IANB anesthesia with articaine local anesthetic provided to 1st Molar |
| BG001 | IANB Articaine Only - 2nd Molar | IANB anesthesia with articaine local anesthetic provided to 2nd Molar |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 5 min after injection |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Initial IANB Articaine | Initial IANB with articaine local anesthetic. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tatiana Botero, Director of Postgraduate Program in Endodontics | University of Michigan | 734-936-2526 | tbotero@umich.edu |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| SUP Articaine | Drug | 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). |
|
|
| SUP Lidocaine | Drug | 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). |
|
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| Result |
| 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. |
| 29397214 | Result | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | IANB Articaine and SUP Articaine - 1st Molar | Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB. |
| BG003 | IANB Articaine and SUP Articaine - 2nd Molar | Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB. |
| BG004 | IANB Articaine and SUP Lidocaine - 1st Molar | Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB. |
| BG005 | IANB Articaine and SUP Lidocaine - 2nd Molar | Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB. |
| BG006 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine. | Count of Participants | Participants |
|
| Region of Enrollment | Two subjects (1 first molar, 1 second molar) were excluded from analysis due to inadequate lip numbness ("missed block") after initial IANB Articaine. | Number | participants |
|
| OG002 |
| IANB Articaine and SUP Lidocaine - 1st Molar |
Supplemental buccal anesthesia with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB. |
| OG003 | IANB Articaine and SUP Lidocaine - 2nd Molar | Supplemental buccal anesthesia with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB. |
|
|
|
| Secondary | Anesthetic Success Rate of an IANB With Articaine | Success rate of an IANB with articaine using a conventional IANB technique | All enrolled participants (N=201) received an IANB with Articaine. Two participants were excluded from data analysis due to inadequate lip numbness (IANB was considered "missed block"); thus N=199 were analyzed for success rate. | Posted | Count of Participants | Participants | 15 min after injection |
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|
|
| 201 |
| 0 |
| 201 |
| 0 |
| 201 |
| EG001 | SUP Articaine | Supplemental buccal anesthesia with articaine local anesthetic. | 0 | 76 | 0 | 76 | 0 | 76 |
| EG002 | SUP Lidocaine | Supplemental buccal anesthesia with lidocaine local anesthetic. | 0 | 73 | 0 | 73 | 0 | 73 |
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| D006571 |
| Heterocyclic Compounds |
| Male |
|