Clinical trial NCT01593930: Evaluation of the Success Rate of Pulpal Anesthesia in Mandibular First Molar Following Infiltration of 4% Articaine Alone and as Supplemental Injection After Inferior Alveolar Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpal Anesthesia
Keywords: Pulp Anesthesia
Articaine
Lidocaine
Lead sponsor: Zahedan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB).

Detailed description: According to inclusion \& exclusion criteria, volunteers will be selected and divided into 4 groups randomly. The clinician who does the injections will not be aware of study purpose. Also the person who does the electric pulp test (EPT); the volunteer and the statistical analyzer will not be aware of group codes. Intervention in each group will be as follow: Group 1-Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 2-Buccal infiltration of two 4% Articaine cartridges with 1/100000epinephrine. Group 3-Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 4- Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine. Before injection a control tooth (contralateral canine) will be tested to understand the accuracy of patient's response to EPT; also for measuring the base line vitality, each tooth will be evaluated by EPT twice before injection. After injection each tooth will be evaluated by EPT every 3 minutes; also every minute the anesthesia of lip and tongue will be checked, up to 15 minutes. The tooth will be discerned "anesthetized" if the subject will not response to 80 reading of EPT in 2 consecutive tests. Finally the information will be recorded and in addition to the success rate the mean time for onset of anesthesia and its mean duration time will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with at least 1 vital first mandibular molar without any restoration or decay

Exclusion Criteria:

* Patients with systemic conditions which eliminate the use of epinephrine
* Patients with history of allergy to amide anesthetics or contents of local anesthetic cartridge
* Pregnant women
* Use of analgesics, opioids or any other drugs which influence the anesthesia

Primary outcomes:
measure: Success rate
timeFrame: Every 3 minutes after injection
Secondary outcomes:
measure: Onset of anesthesia
timeFrame: Every 3 minutes after injection
measure: Duration of anesthesia
timeFrame: Every 3 minutes after onset of anesthesia
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Zahedan university of medical sciences, Vice-chancellor for research
Study officials:
affiliation: Assistant Professor
name: Kaveh Oloomi, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: