Comparative assessment of the effect of methanolic extracts of green tea and chlorhexidine gel on postoperative pain control following surgical removal of impacted third molars
Comparison of the effect of methanolic extracts of green tea and chlorhexidine gel on postoperative pain control following surgicalremoval of impacted third molars
Design
In this clinical trial study, there will be 30 person aged 18-40 that are given after third molar surgery, randomly two compounds of chlorhexidine and green tea . Each participant is assigned a code. .
Settings and conduct
Dental wisdom surgery is done by an oral and maxillofacial specialist in a similar process. Patients are trained to use chlorhexidine or green tea gel twice a day for one week. Choosing a gel type will be random and the participants will not be aware of the type of substance. VAS is used to record the level of pain.
Participants/Inclusion and exclusion criteria
The entering criteria including the person 18-40 years old that have two impacted third molar in mandible and have not the Hemorrhagic disorders , systemic diseases and acute and uncontrolled infection in the surgical ward
the exclusion criteria including Pregnant or lactating people and The presence of lesion in the area of surgery in radiography.
Intervention groups
Chlorhexidine, Green Tea
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171020036896N7
Registration date:2018-12-21, 1397/09/30
Registration timing:registered_while_recruiting
Last update:2018-12-21, 1397/09/30
Update count:0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32119023
Email address
sajadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of the effect of methanolic extracts of green tea and chlorhexidine gel on postoperative pain control following surgical removal of impacted third molars
Public title
the effect of methanolic extracts of green tea and chlorhexidine gel on postoperative pain control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of tow impacted third molar in mandible
The absence of Hemorrhagic disorders and systemic diseases
The absence of acute and uncontrolled infection in the surgical ward
Exclusion criteria:
Smokers
Pregnant or lactating people
The presence of lesion in the area of surgery in radiography
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Two impacted wisdom teeth in each person's mandible
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization or unrestricted method will be used and randomization unit is Individual .we will use from Roll of a die from the methods of simple randomization because there are 2 agent in this study that actually the tool of randomization is dice. So the numbers 1 and 2 are for the first agent(chlorhexidine) 3 and 4 for the second agent (green tea) . The next step Allocation concealment will be done, In such a way that the allocated group is not known before the assignment of the individual. To achieve this goal, a non-transparent, sealed, random sequence envelope is used . In this way, the statistical specialist will provide 30envelopes and each of the randomly generated links will be recorded on a card and the cards are arranged in the envelopes . In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the envelops are enclosed and placed in the box, respectively. At the time of the implementation of the study, according to the order of entry of eligible participants, one of the envelopes is opened respectively and will determine the group assigned to that participant. In this study, the assistant of Pediatric Dentistry examines the participants in terms of inclusion and exclusion criteria. Randomization methods are done by an statistical specialist and performance of the study is done by a trained dental student.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because all two materials are in the same consistency gel, in a uniform shape and color, considering the informed consent, participants are unaware of material. Data analyzer, is also unaware of the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of kerman University of Medical Sciencess
Street address
Vice-Chancellor for Research, Building of Kerman University of Medical Sciences, Tahmasbabad cross, Jahad Street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.KMU.REC.1397.240
Health conditions studied
1
Description of health condition studied
The level of postoperative pain of impacted third molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of postoperative pain of impacted third molar
Timepoint
One week
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The two cc methanolic extract of green tea 20 % is applied twice a day for one week after surgery of the impacted wisdom teeth by the patient on the surgical site.
Category
Treatment - Drugs
2
Description
Control group: The two cc chlorhexidine 2 % is applied twice a day for one week after surgery of the impacted wisdom teeth by the patient on the surgical site.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Faculty of Dentistry
Full name of responsible person
Dr Fatemeh sadat Sajadi
Street address
Department of Maxillofacial Surgery ,School of Dentistry,Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
Sajadi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Tahmasebabad Crossing, Deputy of Research and Technology University
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
60
Public or private sector
Private
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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa street, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
sajadi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa street, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
sajadi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Street, Faculty of Dentistry, Department of pediatrics
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
Email
Sajadi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available