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General information
33
20
3320
empty
Reducing the sample size to 20 patients
Reducing the sample size to 20 patients
empty
کاهش حجم نمونه به 20 بیمار
کاهش حجم نمونه به 20 بیمار
Recruitment centers
#1
Name of recruitment center - English: School of Dentistry, Babol University of Medical Sciences
Name of recruitment center - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی بابل
Full name of responsible person - English: Reza Ghadimi
Full name of responsible person - Persian: رضا قدیمی
Street address - English: Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences
Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 47176
Phone: +98 11 3219 0181
Fax:
Email: graduate@mubabol.ac.ir
Web page address:
Name of recruitment center - English: School of Dentistry, Babol University of Medical Sciences
Name of recruitment center - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی بابل
Full name of responsible person - English: Reza Ghadimi
Full name of responsible person - Persian: رضا قدیمی
Street address - English: Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences
Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4818898435
Phone: +98 11 3219 0181
Fax:
Email: graduate@mubabol.ac.ir
Web page address:
Name of recruitment center - English: School of Dentistry, Babol University of Medical Sciences Name of recruitment center - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی بابل Full name of responsible person - English: Reza Ghadimi Full name of responsible person - Persian: رضا قدیمی Street address - English: Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 471764818898435 Phone: +98 11 3219 0181 Fax: Email: graduate@mubabol.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reza Ghadimi
Full name of responsible person - Persian: رضا قدیمی
Street address - English: Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences
Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 47176
Phone: +98 11 3219 0181
Fax:
Email: graduate@mubabol.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reza Ghadimi
Full name of responsible person - Persian: رضا قدیمی
Street address - English: Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences
Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4818898435
Phone: +98 11 3219 0181
Fax:
Email: graduate@mubabol.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Reza Ghadimi Full name of responsible person - Persian: رضا قدیمی Street address - English: Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 471764818898435 Phone: +98 11 3219 0181 Fax: Email: graduate@mubabol.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effect of Protact mouthwash on local complications caused by wisdom tooth surgery
Design
A clinical trial with a control group, single-blind, randomized, crossover, on 33 patients, the kitset.ir site was used for randomization.
Settings and conduct
This study will be performed by one-blind clinical trial. The population of this study includes patients who are candidates for bilateral mandibular wisdom tooth surgery who refer to the dental clinic of Babol University of Medical Sciences. Due to the blindness of the research method, the surgeon will not know how to code mouthwashes.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the following:
1- Existence of two occult or semi-occult wisdom teeth in the mandible that have almost the same appearance on both sides and both sides are operated by one surgeon.
2 - Age minimum 18 years and maximum 30 years
3- Healthy oral mucosa
Exclusion criteria are:
1- Being a smoker
2- Any systemic conditions; Such as liver and kidney diseases, fever, neutropenia, diabetes, autoimmunity
Intervention groups
Patients receiving Protact mouthwash.
Patients receiving normal saline mouthwash.
Main outcome variables
Wound healing rate and pain rate
General information
Reason for update
Reducing the sample size to 20 patients
Acronym
IRCT registration information
IRCT registration number:IRCT20220220054070N1
Registration date:2022-07-22, 1401/04/31
Registration timing:prospective
Last update:2022-11-12, 1401/08/21
Update count:1
Registration date
2022-07-22, 1401/04/31
Registrant information
Name
mohammad mahdi mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 0814
Email address
mohammadmahdim7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Protact mouth rinse on topical side effects of wisdom teeth extraction and comparison with control group
Public title
Evaluation of the effect of Protact on oral ulcerations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of two occult or semi-occult wisdom teeth in the mandible that have almost the same view on both sides and both sides are operated by a surgeon
Age minimum 18 years and maximum 30 years
Healthy oral mucosa without mucosal or infectious lesions
Exclusion criteria:
Being a smoker
Any systemic conditions; Such as liver and kidney diseases, fever, neutropenia, diabetes, autoimmunity
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient undergoes mandibular wisdom tooth extraction twice (once for the left and once for the right) and receives one of the proactive or normal saline mouthwashes for each operation.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method was performed through the site that patients are divided into two groups that each group of people in the first surgery receive a type of mouthwash and in the second surgery, receive a second mouthwash.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the blindness of the research method, the surgeon will be unaware of how to code mouthwashes.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafruz st.
City
Babol
Province
Mazandaran
Postal code
4818898435
Approval date
2022-04-25, 1401/02/05
Ethics committee reference number
IR.MUBABOL.REC.1401.025
Health conditions studied
1
Description of health condition studied
Localized erythema of the mouth and pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Status of local mucosal erythema at the surgical site including no erythema, mild to moderate erythema and severe erythema
Timepoint
results3 and 7 days after surgery
Method of measurement
Lesions are visually examined and evaluated.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive Protact mouthwash containing thyme extract. Each patient is told to rinse their mouth with 5 ml of mouthwash for 1 minute twice a day, morning and night, one hour after brushing, and until An hour later, do not rinse your mouth with water and avoid eating and drinking. Start this night after surgery and continue for a week.
Category
Treatment - Drugs
2
Description
Control group: Receive mouthwash containing normal saline. Each patient is told to rinse his mouth with 5 ml of mouthwash for 1 minute for 1 minute in the morning and evening, one hour after brushing, and Do not rinse your mouth with water for an hour after that and avoid eating and drinking. Start on the night of surgery and continue for a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4818898435
Phone
+98 11 3219 0181
Email
graduate@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganj Afrooz St., School of Dentistry, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4818898435
Phone
+98 11 3219 0181
Email
graduate@mubabol.ac.ir
Grant name
student research committee babol university of medical sciences
Grant code / Reference number
724134320
Is the source of funding the same sponsor organization/entity?