Forty emergency patients with an irreversible pulpitis of mandibular posterior teeth were randomly assigned to receive either intraosseous injection using the X-tip intraosseous injection system or IAN block as primary injection method for pulpal anesthesia. Pulpal anesthesias were evaluated using an electric pulp tester and endo ice at 5-minute intervals for 15 minutes. Anesthesia’s success or failure rates were recorded and final extracted data were analyzed using SPSS version 12 statistical software. P< 0.05 was considered significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012110510866N1
Registration date:2012-11-05, 1391/08/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-05, 1391/08/15
Registrant information
Name
Hamid Razavian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1624 3998
Email address
razavaian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Treatment protocols used in this study were accepted by Dental Research Committee of Islamic Azad University of Medical Sciences, Khorasgan, Isfahan (Grant No. 821)
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
X-tip intraosseous injection system as a primary anesthesia for irreversible pulpitis of posterior mandibular teeth
Public title
X-tip intraosseous injection system as a primary anesthesia for irreversible pulpitis of posterior mandibular teeth
Purpose
Treatment
Inclusion/Exclusion criteria
no remarkable systemic disease e.g. cardiovascular disease, no history of taking any analgesic drugs during the past 24 hours that would alter the inflammatory response of the pulp, one mandibular posterior tooth with irreversible pulpitis.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Successful anesthesia during root canal therapy may be difficult to obtain. Intraosseous injection significantly improves anesthesia's success as a supplemental pulpal anesthesia, particularly in cases of irreversible pulpitis.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental Research Committee of Islamic Azad University of Medical Sciences,
Street address
Islamic Azad University of Medical Sciences, Khorasgan, Isfahan
City
Khorasgan, Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
821
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
anesthesia
Timepoint
5 min
Method of measurement
response to the cold testing and the electric pulp tester for two sequential intervals was the definitive criterion for successful anesthesia
Secondary outcomes
empty
Intervention groups
1
Description
A single clinician performed all procedures, including diagnosis, injection, and anesthesia evaluation. For the first group, the X-tip intraosseous injection was done according to the manufacturer’s instructions; after evaluating root proximity by radiography, perforation site was located in alveolar mucosa at the distal site of the first molars or at the mesial site of the second molars. A volume of (0.1 ml) 2% lidocaine with 1:100,000 epinephrine (Darou pakhsh, Tehran, Iran) was infiltrated through a 30 gauge needle at the perforation site before intraosseous injection. The perforator drill position was 90-degree angle to the cortical bone and the slow-speed hand piece was activated in a series of short bursts, using light pressure until 2 to 5 seconds had passed. The needle was then engaged in a pen-gripping fashion and 1.8 ml of 2% lidocaine with 1:100,000 epinephrine was injected slowly during 60 seconds. Before inserting the 27 gauge ultrashort X-tip needle into the guide sleeve, the needle was bent with a 60 to 80 degree angle to allow the easy insertion. The perforator was pushed through the alveolar mucosa until the X-tip faced bone.
Category
Other
2
Description
One healthy Contralateral tooth in the same jaw served as negative control and received no anesthesia and was tested by endo Ice and electric pulp tester. A single clinician performed all procedures, including diagnosis, injection, and anesthesia evaluation. In the second group, the IAN block was performed by standard technique. The IAN block group received the same type and volume of anesthetic solution.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic Department of Islamic Azad University
Full name of responsible person
Dr Hamid Razavian
Street address
City
Khorasgan, Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University of Khorasgan-ُSchool of Dentistry-
Full name of responsible person
Dr. Vahid Esfahanian
Street address
Azad University of Khorasgan-ُSchool of Dentistry-
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University of Khorasgan-ُSchool of Dentistry-
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
Department of Endodontics, Islamic Azad University of Medical Sciences, Khorasgan
Full name of responsible person
Dr Maryam Zare Jahromi
Position
Assistant Professor of Endodontics
Other areas of specialty/work
Street address
Department of Endodontics, Islamic Azad University of Medical Sciences, Khorasgan
City
Isfahan
Postal code
Phone
+98 31 1792 2869
Fax
Email
jahromi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Dr Hamid Razavian
Position
Assistant Professor of Endodontics
Other areas of specialty/work
Street address
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 910 300 1269
Fax
Email
hamid.razavian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences,
Full name of responsible person
Dr Hamid Razavian
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
hamid.razavian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)