Objectives: Comparison of two anesthetic techniques.
Design: Randomized، single blind، with out placebo، one center، phase 2-3 trial.
Participants including major eligibility criteria: major inclusion criteria: The patients with impacted third molar; Patients that have no contraindications for oral surgery. major exclusion criteria: The information given by the patient is not reliable.
Target sample size: 44.
Setting and conduct: 22 patients received inferior alveolar nerve block for anesthesia and in 22 other patients gow-gate technique has been used. after surgery questionnaires measuring to pain completed based on VAS by patients.
Time of intervention: after surgery.
primary outcome measures: pain.
secondary outcome measures: additional injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307309515N3
Registration date:2013-09-15, 1392/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-15, 1392/06/24
Registrant information
Name
Ideh Talimkhani
Name of organization / entity
Hamadan faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 2144
Email address
i.talimkhani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the anesthetic efficacy of the gow-gates and inferior alveolar nerve block techniques in patients with impacted third molar.
Public title
Comparison of the anesthetic efficacy of the gow-gates and inferior alveolar nerve block techniques.
Purpose
Prevention
Inclusion/Exclusion criteria
Major inclusion criteria: The patients with impacted third molar; Patients that have no contraindications for oral surgery.
Major exclusion criteria: The information given by the patient is not reliable.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences، Shahid Fahmideh St
City
Hamadan
Postal code
Approval date
2012-06-16, 1391/03/27
Ethics committee reference number
16/35/1011/پ/د
Health conditions studied
1
Description of health condition studied
Impacted tooth
ICD-10 code
k01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
Pain
Timepoint
after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Additional injection
Timepoint
After intervention
Method of measurement
Number
Intervention groups
1
Description
Control group: Gow-Gate injection
Category
N/A
2
Description
Inferior alveolar nerve block injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan faculty of dentistry
Full name of responsible person
Ideh Talimkhani
Street address
Department of oral and maxillofacial surgery، Faculty of dentistry، Hamadan University of Medical Sciences، Shahid Fahmideh St
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research، Hamadan University of Medical Sciences
Full name of responsible person
Heidar Tavilani
Street address
Vice chancellor for research، Hamadan University of Medical Sciences، Shahid Fahmideh St
City
Hamadan
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، Hamadan 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
Hamadan faculty of dentistry
Full name of responsible person
Ideh Talimkhani
Position
General dentist
Other areas of specialty/work
Street address
No381، block C4، Saidiyeh St
City
Hamadan
Postal code
Phone
+98 81 1824 2144
Fax
Email
ideatalimkhani@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan faculty of dentistry
Full name of responsible person
Mohammad Reza Jamalpour
Position
oral and maxillofacial surgeon
Other areas of specialty/work
Street address
Department of oral and maxillofacial surgery، Faculty of dentistry، Hamadan University of Medical Sciences، Shahid Fahmideh St
City
Hamadan
Postal code
Phone
+98 81 1838 1081
Fax
Email
jamalpour@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)