Hydralazine HCl is antagonist of epinephrine. We evaluate the Hydralazine HCl effect on reversal time of normal sensation and trauma to the soft tissue after mandibular block injection in patient of 18-80 years of age. In this randomized single blind controlled clinical trial 50 patients have been divided in two groups and the process of this study described to them (approved by medical sciences). On completion of the dental treatment, patients randomly received a Hydralazine HCl or a sham injection (sham injection in which a needle does not penetrate the tissue) in the same site as the local anesthetic injection. We evaluate reversal time of normal sensation of soft tissue every 15 minutes by soft tapping with index finger and also we assess the vital sign, incidence of trauma to soft tissue for 3-5 hours and patients have been followed for at least 48 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312202877N2
Registration date:2014-02-08, 1392/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-08, 1392/11/19
Registrant information
Name
Omid Fakheran
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1661 9472
Email address
fakheran@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Isfahan University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-06-01, 1393/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Hydralazine on duration of soft tissue local anesthesia following dental treatment
Public title
Effect of Hydralazine on duration of soft tissue local anesthesia following dental treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
Male or female greater than or equal to 18 years; Sufficiently healthy, as determined by the Investigator, to receive routine dental care; Requires one or two cartridges of local anesthesia administered by inferior alveolar nerve block techniques; Understands and gives written informed consent; Can communicate with the Investigator and study staff, and can understand and comply with the requirements of the protocol
Exclusion Criteria:
History or presence of any condition that contraindicates routine dental care; Concurrent conditions: any incapacitating medical condition (e.g. unstable angina, uncontrolled cardiac arrhythmias, uncontrolled hypertension, uncontrolled hyperthyroidism); significant infection or inflammatory process of the oral cavity; Concomitant medications: use of an opioid or opioid-like analgesic (e.g. codeine, tramadol, pentazocine) within 48 hours prior to administration of anesthetic; Allergy or intolerance to lidocaine, articaine, prilocaine, mepivacaine, epinephrine, levonordefrin, sulfites, phentolamine, or topical benzocaine; Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street, Isfahan, Iran, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Approval date
2010-12-08, 1389/09/17
Ethics committee reference number
288240
Health conditions studied
1
Description of health condition studied
The effectiveness of Hydralazine HCl on the adverse effect of local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Soft tissue local anesthesia
Timepoint
Just one day
Method of measurement
ُQuestionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group:
completion of the dental treatment, patients randomly received a Sham injection in the same site as the local anesthetic injection
Category
Treatment - Drugs
2
Description
Intervention group:
completion of the dental treatment, patients randomly received a Hydralazine HCl injection in the same site as the local anesthetic injection
4 mg/ml Hydralazine HCl injection, (Rubio , Spain)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Omid Fakheran
Street address
226, Apadana Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University of Medical Sciences
Full name of responsible person
Omid Fakheran Esfahani
Street address
Hezar Jarib Street, Isfahan, Iran, Isfahan University of Medical Sciences, Vice Chancellor for Research
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Omid Fakheran
Position
Periodontics Resident
Other areas of specialty/work
Street address
226, Aftab alley, Apadana Street, Isfahan, Iran
City
Isfahan
Postal code
8165876763
Phone
+98 31 1661 9472
Fax
Email
fakheran@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Omid Fakheran
Position
Periodontics Resident
Other areas of specialty/work
Street address
Hezar Jarib Street, Isfahan, Iran, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1661 9472
Fax
+98 31 1224 0262
Email
fakheran@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Omid Fakheran
Position
Periodontics Resident
Other areas of specialty/work
Street address
Hezar Jarib Street, Isfahan, Iran, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1661 9472
Fax
Email
fakheran@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)