The purpose of this study is to investigate the influence of 0.2% (w/v) chlorhexidine gluconate mouthwash on the severity of post-extraction pain.
Design
A parallel, double blind, single center controlld trial
sample size is 170
Settings and conduct
0.5 to 1 h before performing extractions, subjects will be given a dark bottle containing 15 ml of either chlorhexidine 0.2% or placebo. Patients will be asked to rinse the assigned solutions around their mouth for two minutes before spitting out. Subjects undergo the operation under local anesthesia with one 1.8-ml capsule of 2% lidocaine and 1:80 000 Epinephrine. Postoperative pain will be assessed by considering the following parameters: (1) pain will be evaluated using a visual analog scale (VAS); (2) the number of analgesic tablets ingested.Patients' postoperative pain and analgesic intake will be recorded by 4 telephone interviews 6, 12, 24 and 48 h after tooth extraction.
Participants/Inclusion and exclusion criteria
To be eligible for the study the patients have to be between 18 and 80 years old.
patients be healthy and not on any regular medication.
No patient have any of pain inducing conditions such as an aching tooth at the time of the surgery.
Intervention groups
chlorhexidine group (study group)
placebo (control group)
Main outcome variables
Pain after tooth extraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121223011856N2
Registration date:2019-04-25, 1398/02/05
Registration timing:registered_while_recruiting
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
daryoosh hasheminia
Name of organization / entity
.
Country
Iran (Islamic Republic of)
Phone
+98 913 325 7106
Email address
haghighat@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of preoperative chlorhexidine mouthwash on pain after lower posterior teeth removal : A Randomized, Double blind Clinical Trial
Public title
Effect of Chlorhexidine on postextrction pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients will be between 18 and 80 years old.
patients be healthy and not on any regular medication.
patients will not have any of pain inducing conditions such as an aching tooth at the time of the surgery.
Exclusion criteria:
patients will be excluded if they ingested any medications including oral contraceptives, analgesics and antibiotics as of 5 days prior to the operation.
smokers will be excluded
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated to a treatment group based on the flip of a coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
0.5 to 1 h before performing extractions, subjects will be given a dark bottle containing 15 ml of either chlorhexidine 0.2% or placebo but they have no idea of the type of the solution. we will ask the clinician to perform extractions in equal situation for all patients while he has no information about the two groups.
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 science
Street address
Hezarjarib st
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.482
Health conditions studied
1
Description of health condition studied
postoperative pain after tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
patients pain
Timepoint
6,12,24 and 48 hours after extractio
Method of measurement
patients pain will be assessed using a VAS (Visual Analog Scale) and the number of analgesic used
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.5 to 1 hours before performing extractions patient in intervention group will be given a dark bottle containing 15 ml of 0.2% chlorhexidine gluconate mouthwash (BEHSA). they will rinse the solution around their mouth for two minutes. the extractions will be done by an expert clinician. After performing extractions, patients will receive 10 pills of Acetaminophen 325 (EXIR) to be taken in case of excessive pain. patient analgesic intake and postoperative pain will be recorded by 4 telephone interviews 6, 12, 24 and 48 postoperative hours. Subjects will be asked to make VAS evaluation of their pain. Likewise subjects will be asked if they have used any prescribed analgesics and if so, the dosage will be asked.
Category
Prevention
2
Description
Control group: 0.5 to 1 hours before performing extractions patient in control group will be given a dark bottle containing 15 ml of placebo mouthwash (one liter of placebo contains 1 liter of sterile normal saline (Samen company) plus one drop of natural edible colours made by colour splash company) . they will rinse the solution around their mouth for two minutes. the extractions will be done by an expert clinician. After performing extractions, patients will receive 10 pills of Acetaminophen 325 (EXIR) to be taken in case of excessive pain. patient analgesic intake and postoperative pain will be recorded by 4 telephone interviews 6, 12, 24 and 48 postoperative hours. Subjects will be asked to make VAS evaluation of their pain. Likewise subjects will be asked if they have used any prescribed analgesics and if so, the dosage will be asked.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical science
Full name of responsible person
ُُShaqayeq Ramezanzade
Street address
Hezarjarib st
City
Isfahan
Province
Isfehan
Postal code
81746--73461
Phone
+98 21 8871 4273
Email
shaqayeq.ramezanzade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Haghighat
Street address
Hezarjarib st
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 21 8871 4273
Email
Haghighat@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Haghaighat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezargarib st
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 21 8871 4273
Email
haghighat@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Haghighat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
hezarjarib st
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 219025795
Email
haghighat@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Haghighat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
hezarjarib st
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 219024795
Email
haghighat@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD