Comparison of anesthetic efficacy of articaine as a primary injection between infiltration in the incisive/mental nerve region and inferior alveolar nerve block to treat mandibular premolar teeth with irreversible pulpitis: A, randomized, controlled, parallel, double blind study.
(1) Objectives: To compare the anesthetic efficacy of 4% articaine between inferior alveolar nerve block and incisive/ mental nerve infiltration techniques during root canal treatment of mandibular premolar teeth with irreversible pulpitis.
(2) Design: The study design is a randomized, controlled, parallel, double blind study. 64 participants are all adults between 18-65 years old who seek treatment for mandibular premolar teeth diagnosed with irreversible pulpitis. Patients randomly divided in to two groups.
(3) Setting and conduct: one group will receive inferior alveolar nerve block(IANB) and the other incisive and mental nerve infiltration(IMNI) by a well-trained dentist. When the anesthesia Status is confirmed by the observer through using electric pulp tester, the regular root canal treatment will be initiated by the dentist. The success rate, onset/duration of anesthesia and pain intensity (from injection, during the treatment & 1 week after the treatment) of each technique will be measured and compared.
(4) Participants including major eligibility criteria: Healthy patients who seek treatment for mandibular premolar teeth diagnosed with irreversible pulpitis were included; patients with systemic diseases and those are out of the range 18-65 years were excluded.
(5) Intervention: Intervention group: mental/incisive injection, control group: IANB injection
(6) Main outcome measures: Primary outcome: success of anesthesia, secondary outcome: the onset, duration and pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072123278N1
Registration date:2016-06-01, 1395/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-01, 1395/03/12
Registrant information
Name
Ashraf Shubbar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1173
Email address
a-mashkourshubbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-08-31, 1394/06/09
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthetic efficacy of articaine as a primary injection between infiltration in the incisive/mental nerve region and inferior alveolar nerve block to treat mandibular premolar teeth with irreversible pulpitis: A, randomized, controlled, parallel, double blind study.
Public title
The efficacy of articaine in mental injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients who seek treatment for mandibular premolar teeth diagnosed with irreversible pulpitis; patients who accept to sign the informed consent
Exclusion criteria:
Hematological and clotting disorders; neurological disorders; allergies to local; anesthetic drugs or sulfites; pregnancy at the time of the study; Younger than 18 year older than 65 year; patients with a history of significant medical conditions (American Society of Anesthesiologists class II or higher); clinically observed lesions or swellings at the injection site
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Permuted block randomization using sealed enveloped
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran, District 6, Pour Sina St
City
Tehran
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
IR.TUMS.REC.1394.1906
Health conditions studied
1
Description of health condition studied
Local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Anesthesia
Timepoint
during the root canal treatment procedure
Method of measurement
by VAS(visual analogue scale) and EPT(electric pulp tester)
Secondary outcomes
1
Description
the onst of the anesthesia
Timepoint
before starting the root canal treatment
Method of measurement
by EPT (electric pulp tester)
2
Description
the duration of anesthesia
Timepoint
time from the confirmation of anesthesia until the anesthesia subsided or the patient start to have pain again
Method of measurement
electric pulp tester and visual analogue scale
3
Description
pain
Timepoint
from injection through out the treatment and one week after the treatment
Method of measurement
visual analogue scale (VAS)
Intervention groups
1
Description
Intervention group: IMNI: incisive/mental nerve infiltration
Injection will be performed with 1.8 ml of articaine 4%with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) between the two mandibular premolars teeth, if the second premolar is missing the injection will be distal to the first premolar apex and if the first premolar was missing the injection will be at the apex of the second premolar. After the anesthesia has been confirmed with EPT, the regular root canal treatment will be initiated. If moderate or severe pain on the basis of the values of The Heft-Parker visual analogue scale (HP-VAS) is anticipated the patient will be injected with another cartridge of 4% articaine with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) by the inferior alveolar block technique.
Category
Treatment - Other
2
Description
Control group: Inferior alveolar nerve block (IANB).
After isolation of the teeth with cotton rolls and drying them with gauze, fluoride gel or tooth paste will be applied to the probe tip of electric pulp tester and will be placed midway between the gingival margin and the occlusal edge of the tooth that is being tested (according to the manufacturer’s guidelines).
Injection will be performed with 1.8 ml of 4% articaine with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) according to malamed technique. After the anesthesia has been confirmed with EPT, the regular root canal treatment will be initiated. If moderate or severe pain on the basis of the values of The Heft-Parker visual analogue scale (HP-VAS) is anticipated the patient will be injected with another cartridge of the same solution injection to the mental foramen region.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ashraf Shubbar
Street address
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ashraf Shubbar
Street address
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Dentistry, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sholeh Ghabraei
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
sholhghabraei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sholeh Ghabraei
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
sholhghabraei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Ashraf shubbar
Position
Postgraduate student of endodontics
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
ashraf.shubbar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)