Zahedan university of medical sciences, Vice-chancellor for research
Zahedan, Iran
Completed
NCT Number: 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
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).
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Lidocaine(IANB)
OtherInferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
Other names: Persocaine E
1 Articaine(Infiltration)
OtherBuccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other names: Septanest
2 Articaine(Infiltration)
OtherBuccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
Other names: Septanest
Lidocaine(IANB)+1Articaine(Infiltration)
OtherInferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other names: Persocaine E + Septanest
Primary outcomes
-
Success rate
Time frame: Every 3 minutes after injection
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. The anesthesia will be considered successful if the subject will not response to EPT at the 80 reading in 2 consecutive tests.
Secondary outcomes
-
Onset of anesthesia
Time frame: Every 3 minutes after injection
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. No response from the patient at the 80 reading of EPT in 2 consecutive tests will be discerned as "completely anesthetized" and the time will be recorded as "onset of anesthesia".
-
Duration of anesthesia
Time frame: Every 3 minutes after onset of anesthesia
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after onset of anesthesia to determine when the subject will response again at the 80 reading of EPT.
Sponsors and collaborators
Lead sponsor
Zahedan University of Medical Sciences
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- May 8, 2012
- Registry last updated
- Jan 29, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.