Investigating the efficacy of using scrophularia striata mouthwash in preventing dry socket in mandibular third molar
Design
This study is a double-blinded clinical trial. The study population will be included those who refer to the department of surgery of dental school of Kermanshah university of medical sciences.140 eligible patients will be selected conveniently and randomly will be assigned to intervention and control groups.
Settings and conduct
This study that will be conducted in the ental school of Kermanshah is a double-blinded one that data analysts and researchers are kept blind to the allocation of study groups. At baseline age, sex, number and location of extracted teeth (upper and lower jaw), type of extracted tooth, cause of tooth extraction and degree of difficulty during tooth extraction are recorded in the checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People require tooth extraction
Exclusion criteria: People with systemic diseases including rheumatism, diabetes, lupus, MS, septicemia, hepatitis, AIDS; Pregnant women; Painful conditions such as teeth requiring root canal treatment, patients at higher risk of dry cavity; People with neurological diseases
Intervention groups
The intervention group will receive a Scrophularia striata mouthwash after tooth extraction. Control groups do not receive an intervention
Main outcome variables
Dry socket Outbreak; Rate of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N141
Registration date:2020-03-05, 1398/12/15
Registration timing:prospective
Last update:2020-03-05, 1398/12/15
Update count:0
Registration date
2020-03-05, 1398/12/15
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of using scrophularia striata mouthwash in preventing dry socket in mandibular third molar
Public title
Investigating the efficacy of using scrophularia striata mouthwash in preventing dry socket in mandibular third molar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People require tooth extraction
Exclusion criteria:
People with systemic diseases including rheumatism, diabetes, lupus, MS, septicemia, hepatitis, AIDS
pregnant women
Painful conditions such as teeth requiring root canal treatment, patients at higher risk of dry cavity
People with neurological disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 70. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, data analysts and researchers are kept blind to the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
ir.kums.rec.1398.1173
Health conditions studied
1
Description of health condition studied
Dry socket
ICD-10 code
k10.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
Dry socket Outbreak
Timepoint
3 and 7 days after the end of the study
Method of measurement
According to the BLUM
2
Description
Rate of pain
Timepoint
3 and 7 days after the end of the study
Method of measurement
Based on visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive Erminia euchroma mouthwash after tooth extraction
Category
Treatment - Other
2
Description
Control groups do not receive an intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Fatemeh Sadat Bagheri
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
ffbagheri.ffb@gmil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Bagheri
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
ffbagheri.ffb@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hesamodin Nazari
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
h.nazari@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Bagheri
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
ffbagheri.ffb@gmil.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail