Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars
NCT ID: NCT01496846
Last Updated: 2017-10-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
201 participants
INTERVENTIONAL
2011-09-30
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IANB Articaine
IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.
IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
SUP Articaine
SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.
IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
SUP 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).
SUP Lidocaine
SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
SUP 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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
SUP 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).
SUP 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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* irreversible pulpitis in mandibular molar
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dentsply International
INDUSTRY
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mathilde Peters, DMD, PhD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mathilde C Peters, DMD, PhD
Role: STUDY_CHAIR
University of Michigan
Tatiana Botero, DDS, MS
Role: STUDY_DIRECTOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Michigan, School of Dentistry Clinics
Ann Arbor, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUM00049692
Identifier Type: OTHER
Identifier Source: secondary_id
HUM00088384
Identifier Type: OTHER
Identifier Source: secondary_id
PG#N014189
Identifier Type: -
Identifier Source: org_study_id