the aim of this study is evaluate buccal infiltration by4٪ articaine (epinephrine 1:100000) for mandibular third molar surgery and compare it with inferior alveolar nerve block by 2٪ lidocaine(epinephrine 1:100000).
Methods: the study is a double blinded clinical trial design.all patient will be
17_45 yeras old ,need to third molar surgry IN BOTH SIDE,
THE same situation pederson & four point rating scale,coprative and they will be enter to study valantary & knowingly.
35(70 case) patients underwent removal of bilateral lower third molar surgery in 2 seprate appointments. the patients randomly will received mandibular buccal infiltration of 4٪ articaine 1/100000 or inferior alveolar nerve block of 2٪ lidocaine 1/100000.onset time,duration of anaesthetic effect, need to re-injectin, pain duraing and after surgery, maximum mouth opening, and complications such as dry socket ,hematoma and nerve injury will recorded and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050933444N4
Registration date:2017-07-30, 1396/05/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-30, 1396/05/08
Registrant information
Name
Aida Rashidi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 960 5228
Email address
sarafraz@kish.sharif.edu
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of buccal infiltration by 4% articaine versus inferior alveolar nerve block by 2%lidocaine in mandibular third molar surgery
Public title
Comparison of local anestasia by 4% articaine versus inferior alveolar nerveanestasia by 2%lidocaine in mandibular third molar surgery
Purpose
Supportive
Inclusion/Exclusion criteria
INCUSION CRITERIS:
17_45 yeras old ,need to third molar surgry IN BOTH SIDE,
THE same situation pederson & four point rating scale,coprative
EXCLUSION:
pregnant.infelamation.uncoprative.use NSAID.alergic pationt
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
HORMOZGAN university
Street address
chamran blv
City
bandarabbas
Postal code
Approval date
2017-05-04, 1396/02/14
Ethics committee reference number
Hums.REC.1395.136
Health conditions studied
1
Description of health condition studied
surgery
ICD-10 code
T81
ICD-10 code description
Complications of procedures, not elsewhere classified
Primary outcomes
1
Description
time of numb
Timepoint
after injection
Method of measurement
ask
2
Description
during of numb
Timepoint
after injection &surgury
Method of measurement
ask
3
Description
measure of injection
Timepoint
after surgury
Method of measurement
carpool
4
Description
pain
Timepoint
after surgury
Method of measurement
ask
5
Description
Infection
Timepoint
after surgury
Method of measurement
visit
6
Description
trismoos
Timepoint
after surgury
Method of measurement
visit
7
Description
dry socket
Timepoint
after surgury
Method of measurement
visit
Secondary outcomes
1
Description
pain
Timepoint
after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
randomly,in one part.will be injectionin mandibular buccal. infiltration of 4٪ articaine 1/100000
Category
Treatment - Drugs
2
Description
in the other side,will be injection inferior alveolar nerve block of 2٪ lidocaine 1/100000
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
personal office
Full name of responsible person
Seifollah hemat
Street address
floor3-Kimiya bulding-Fatemi st
City
Bandar abbas
2
Recruitment center
Name of recruitment center
DENTAL UNIVERSITY OF HORMOZGAN
Full name of responsible person
Street address
City
bandar abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
DENTAL UNIVERSITY OF HORMOZGAN
Full name of responsible person
Seifoallah hemat
Street address
Fatemiye st
City
Bandarabbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DENTAL UNIVERSITY OF HORMOZGAN
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
DENTAL UNIVERSITY OF HORMOZGAN
Full name of responsible person
Aida Rashidi
Position
student
Other areas of specialty/work
Street address
floor 4- hoursan buiding-Golshahr street
City
Bandarabbas
Postal code
Phone
+98 76 3367 6611
Fax
Email
aida_rashidi_1370@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
DENTAL UNIVERSITY OF HORMOZGAN
Full name of responsible person
Seifollah Hemat
Position
Teacher
Other areas of specialty/work
Street address
Dental clinin-Shariati hospytal -Naser blv
City
Bandarabbas
Postal code
Phone
+98 76 3322 5424
Fax
Email
aida_rashidi_1370@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
DENTISTRY university
Full name of responsible person
AIDA RASHIDI
Position
student
Other areas of specialty/work
Street address
golshahr st
City
Bandarabbas
Postal code
Phone
00
Fax
Email
aida_rashidi_1370@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)