Protocol summary

Study aim
improvement the quality of treatment reduce the cost of treatment
Design
The clinical trial has a control group, with factorial groups, three blind strains and patients are randomly selected so that the clinical caregiver gives half of the samples as a placebo and half as a probiotic supplement. Phase 3 is on 50 patients.
Settings and conduct
This project is done in Kashan Dental School. blood sampling is performed first to measure the level of inflammatory and anxiety factors before the intervention. Then, for one month, one group receives a bioflora probiotic supplement and the other group receives a placebo. After one month, surgery is performed. And factor levels are re-measured to compare whether we have a greater reduction in inflammatory and anxiety factor levels with probiotic supplements. In this study, neither the patients, nor the person performing the surgery, nor the person analyzing the results knew the type of medication received.
Participants/Inclusion and exclusion criteria
Entry conditions: patients having more than 18 years_ patients having impacted third molar exit conditions: having inflammation or mental disorders- Taking probiotics during the last three months
Intervention groups
There are two groups. In both groups, blood sampling is performed first to measure the level of inflammatory and anxiety factors before the intervention. Then, for one month, one group receives a bioflora probiotic supplement and the other group receives a placebo. After one month, surgery is performed. And factor levels are re-measured to compare whether we have a greater reduction in inflammatory and anxiety factor levels with probiotic supplements.
Main outcome variables
NO Malondialdehyde Total antioxidant capacity Total Glutathione high-sensitivity C-reactive protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210811052144N1
Registration date: 2022-01-24, 1400/11/04
Registration timing: registered_while_recruiting

Last update: 2022-01-24, 1400/11/04
Update count: 0
Registration date
2022-01-24, 1400/11/04
Registrant information
Name
Vahid Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5360 2257
Email address
vahidkiyani448@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotic supplementation effect on anxiety, inflammatory factors and oxidative stress biomarkers in patients undergoing third molar surgery
Public title
Evaluation of probiotic supplementation effect on anxiety, inflammatory factors and oxidative stress biomarkers in patients undergoing third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients having impacted third molar
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and all people involved in writing and implementing the plan are kept blind. Just clinical clinical caregiver are aware about the kind of drug.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan, Qutb Ravandi Blvd, Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715985191
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.KAUMS.REC.1397.067

Health conditions studied

1

Description of health condition studied
Anxiety caused by wisdom tooth surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
NO
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry

2

Description
Malondialdehyde
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry

3

Description
Total antioxidant capacity
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry

4

Description
Total Glutathione
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry

5

Description
high-sensitivity C-reactive protein
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Recipient of bioflora probiotic - product of takgene company - contains Lactobacillus acidophilus, Bifidobacterium ‌ Bifidum, Bifidobacterium Lactis and Bifidobacterium Langum - Dose: 1/8 × 109 CFU / Capsule - How to use: once a day for one month
Category
Treatment - Drugs

2

Description
Control group: recipient of Placebo - one a day for a month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry Kashan Faculty of Dentistry of Kashan University of Medical Sciences
Full name of responsible person
Doctor Amirsalar Sayedyahossein
Street address
Qutb Ravandi Blvd., Kashan Town
City
کاشان
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5325 3156
Email
amirsalar.sayedyahossein@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
امیر سالار سید یاحسین
Street address
Qutb Ravandi Blvd., Kashan Town
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5325 3156
Email
amirsalar.sayedyahossein@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Vahid Kiani
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qotb Ravandi Blvd
City
کاشان
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5325 3156
Email
vahidkiyani448@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Doctor Amirsalar Sayedyahossein
Position
هیئت علمی
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qutb Ravandi Blvd- Kashan
City
کاشان
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5325 3156
Email
amirsalar.sayedyahossein@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Vahid Kiani
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qotb Ravandi Blvd
City
کاشان
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5325 3156
Email
vahidkiyani448@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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