Evaluation of ice therapy as a pretreatment on reduction of injection pain and bleeding during periodontal surgery of maxilla after administration of prilocaine as a local anesthesia.
The aim of this study was to determine the effect of pretreatment with ice on reducing pain during injection and bleeding during periodontal surgery after administration of prilocaine(without vasoconstrictors) as a local anesthetic in maxillary periodontal surgery.Inclusion criteria: no history of systemic diseases especially hemorrhagic disorders, Women must not be pregnant, Patients must not have fear of surgery, Patient must not have used acetaminophen, phenastin, naproxen, or ibuprofen
Exclusion criteria: people with mental retardation, children, patients that have used analgesics.80 patients aged 12 to 70 were randomly chosen and divided into two group the control and the study group. The indication for performing the periodontal surgery in the maxilla is the same in both groups.Both have been matched for interfering factors like sex and age. The experimental group are pretreated with ice packs on the injection site for 2 minutes, whereas the control group is not pretreated with ice.after the surgery the patient’s pain is assessed using the Visual analog scale analysis in which the patient reports his or her pain by themself.This scale is graded from 0 to 5, where 0 means no pain and 5 means severe pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502077128N5
Registration date:2015-03-26, 1394/01/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Adileh Shirmohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
shirmohamadia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ice therapy as a pretreatment on reduction of injection pain and bleeding during periodontal surgery of maxilla after administration of prilocaine as a local anesthesia.
Public title
Evaluation of ice therapy as a pretreatment on reduction of injection pain and bleeding during periodontal surgery of maxilla after administration of prilocaine as a local anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:no history of systemic diseases especially hemorragic disorders.women must not be pregnant.patients must not have fear of surgery.patient must not have used acetaminophen with phenastin,naproxen,ibuprofen,
Exclusion criteria:people with mental retardation, children,patient that have used analgesics.
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dentistry Faculty Of Tabriz
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
9399
Health conditions studied
1
Description of health condition studied
periodontal disease
ICD-10 code
k05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
pain
Timepoint
before injection
Method of measurement
patient reaction and expression
Secondary outcomes
empty
Intervention groups
1
Description
precooling with ice before injection
Category
N/A
2
Description
No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty Of Tabriz
Full name of responsible person
Dr Adileh Shirmohamadi
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
2
Recruitment center
Name of recruitment center
Dental and Periodontal Research Center
Full name of responsible person
Dr Reza Pourabbas
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dentistry Faculty Of Tabriz
Full name of responsible person
Dr Adileh Shirmohamadi
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dentistry Faculty Of Tabriz
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Dental and Periodontal Research Center
Full name of responsible person
Dr Reza Pourabbas
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental and Periodontal Research Center
Proportion provided by this source
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
Dentistry Faculty Of Tabriz
Full name of responsible person
Nasim Abedini
Position
Undergraduate student
Other areas of specialty/work
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
nasim_abedini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry faculty of tabriz
Full name of responsible person
Dr Adileh Shirmohamadi
Position
Professor
Other areas of specialty/work
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
shirmohamadia@yahoo.com
Web page address
www.tbzmed.ac.ir/research
Person responsible for updating data
Contact
Name of organization / entity
Dentistry Faculty Of Tabriz
Full name of responsible person
Dr Adileh Shirmohamadi
Position
Professor
Other areas of specialty/work
Street address
Tabriz Faculty Of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
shirmohamadia@yahoo.com
Web page address
www.tbzmed.ac.ir/research
Sharing plan
Deidentified Individual Participant Data Set (IPD)