Irreversible Pulpitis
Conditions
Keywords
Articaine, Lidocaine, Anesthesia, Local, Endodontics, Molar, Dental Pulp Diseases
Brief 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.
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: 1. What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration? 2. Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB? 3. 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.
Interventions
DRUGIANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
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).
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).
Sponsors
Dentsply International
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients * irreversible pulpitis in mandibular molar
Exclusion criteria
* below 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthetic Success Rate of Supplemental Infiltration Injection | 5 min after injection | Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anesthetic Success Rate of an IANB With Articaine | 15 min after injection | Success rate of an IANB with articaine using a conventional IANB technique |
Countries
United States
Participant flow
Recruitment details
Protocol enrollment: 201 subjects with 1 study tooth.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| IANB Articaine Only - 1st Molar IANB anesthesia with articaine local anesthetic provided to 1st Molar | 28 |
| IANB Articaine Only - 2nd Molar IANB anesthesia with articaine local anesthetic provided to 2nd Molar | 24 |
| IANB Articaine and SUP Articaine - 1st Molar Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB. | 36 |
| IANB Articaine and SUP Articaine - 2nd Molar Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB. | 40 |
| IANB Articaine and SUP Lidocaine - 1st Molar Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB. | 35 |
| IANB Articaine and SUP Lidocaine - 2nd Molar Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB. | 38 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| IANB Articaine (All Participants) | Inadequate lip numbness: missed block | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 18 | 40 years STANDARD_DEVIATION 14 | 38 years STANDARD_DEVIATION 15 | 35 years STANDARD_DEVIATION 14 | 40 years STANDARD_DEVIATION 14 | 39 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 27 participants | 24 participants | 36 participants | 40 participants | 35 participants | 38 participants | 199 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 12 Participants | 23 Participants | 22 Participants | 19 Participants | 102 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants | 17 Participants | 13 Participants | 19 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 201 | 0 / 76 | 0 / 73 |
| other Total, other adverse events | 0 / 201 | 0 / 76 | 0 / 73 |
| serious Total, serious adverse events | 0 / 201 | 0 / 76 | 0 / 73 |
Outcome results
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
Time frame: 5 min after injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IANB Articaine and SUP Articaine - 1st Molar | Anesthetic Success Rate of Supplemental Infiltration Injection | 22 Participants |
| IANB Articaine and SUP Articaine - 2nd Molar | Anesthetic Success Rate of Supplemental Infiltration Injection | 25 Participants |
| IANB Articaine and SUP Lidocaine - 1st Molar | Anesthetic Success Rate of Supplemental Infiltration Injection | 23 Participants |
| IANB Articaine and SUP Lidocaine - 2nd Molar | Anesthetic Success Rate of Supplemental Infiltration Injection | 12 Participants |
p-value: 0.901Chi-squared
p-value: 0.004Chi-squared
Secondary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IANB Articaine and SUP Articaine - 1st Molar | Anesthetic Success Rate of an IANB With Articaine | 27 Participants |
| IANB Articaine and SUP Articaine - 2nd Molar | Anesthetic Success Rate of an IANB With Articaine | 23 Participants |
p-value: 0.437Chi-squared