Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01862614
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.

Condition or Disease	Intervention/Treatment	Phase
Anesthetic Effectiveness	Drug: Articaine Hydrochloride + Epinephrine; Drug: Buffered Articaine Hydrochloride + Epinephrine	Phase 4

Detailed Description

Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized, Double-blind Study of the Anesthetic Efficacy of Buffered Articaine as a Primary Buccal Infiltration of the Mandibular First Molar.
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buffered Articaine at 1st Appointment Subjects received an infiltration injection of 1.8cc buffered 4% articaine.	Drug: Buffered Articaine Hydrochloride + Epinephrine
Active Comparator: Articaine at 1st Appointment Subjects received an infiltration injection of 1.8cc 4% articaine (unbuffered).	Drug: Articaine Hydrochloride + Epinephrine

Outcome Measures

Primary Outcome Measures

1. Number of Participants Achieving Pulpal Anesthesia. [60 minutes per injection sequence.]

   An electric 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. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Between the age of 18-65 years.

• in good health (ASA classification II or higher).

• able to provide informed consent.

Exclusion Criteria:

• allergy to articaine.

• history of significant medical problems (ASA classification of III or worse).

• diagnosed depression (taking tri-cyclic antidepressant medications to control).

• have taken central nervous system (CNS) depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing.

• lactating or pregnant.

• inability to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Dentistry, Postle Hall	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Abdulwahab M, Boynes S, Moore P, Seifikar S, Al-Jazzaf A, Alshuraidah A, Zovko J, Close J. The efficacy of six local anesthetic formulations used for posterior mandibular buccal infiltration anesthesia. J Am Dent Assoc. 2009 Aug;140(8):1018-24.
• Burmeister CH. A practical method for the extemporaneous preparations of a buffered anesthetic solution. J Am Dent Assoc 22:1514, 1935.
• Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042.
• Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. Epub 2006 Feb 17.
• Robertson D, Nusstein J, Reader A, Beck M, McCartney M. The anesthetic efficacy of articaine in buccal infiltration of mandibular posterior teeth. J Am Dent Assoc. 2007 Aug;138(8):1104-12.
• Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52.

• Responsible Party: John Nusstein, Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT01862614
• Other Study ID Numbers: Buffered Articaine
• First Posted: May 24, 2013
• Last Update Posted: May 26, 2021
• Last Verified: May 1, 2021

• Keywords provided by John Nusstein, Professor, Ohio State University: Degree of pulpal anesthesia obtained.; Primary infiltration in the lower first molar.; Buffered local anesthetic.
• Additional relevant MeSH terms: Epinephrine; Racepinephrine; Carticaine; Epinephryl borate

Study Results

Participant Flow

Recruitment Details	80 subjects will be recruited in this crossover study. Each of the subjects will receive the injection regimens at 2 separate appointments spaced at least 2 weeks apart.

Arm/Group Title	Articaine (First)	Buffered Articaine (First)
Arm/Group Description	Subjects receiving 1.8cc articaine injection at first appointment.	Subjects receiving injection of 1.8cc buffered articaine at first appointment.
Period Title: First Appointment.
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0
Period Title: First Appointment.
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0
Period Title: First Appointment.
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Articaine
Arm/Group Description	Subjects receiving articaine injection.
Overall Participants	80
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	80 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (2.5)
Sex: Female, Male (Count of Participants)
Female	38 47.5%
Male	42 52.5%
Region of Enrollment (Count of Participants)
United States	80 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Achieving Pulpal Anesthesia.
Description	An electric 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. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Time Frame	60 minutes per injection sequence.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articaine	Buffered Articaine
Arm/Group Description	Subjects receiving articaine injection.	Subjects receiving an injection of 1.8cc buffered articaine.
Measure Participants	80	80
Count of Participants [Participants]	52 65%	57 NaN

Adverse Events

Arm/Group Title	Articaine		Buffered Articaine
Arm/Group Description	Subjects receiving injection of 1.8cc 4% articaine.		Subjects receiving injection of 1.8cc buffered 4% articaine.
All Cause Mortality
	Articaine		Buffered Articaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Articaine		Buffered Articaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/80 (0%)
Other (Not Including Serious) Adverse Events
	Articaine		Buffered Articaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.