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Investigating the effect of using a water-soluble probiotic supplement in the form of mouthwash on periodontal and gingival indicators and common pathogenic bacteria that cause periodontal diseases after scaling and leveling the root surface in patients with moderate to severe chronic periodontitis

Protocol summary

Study aim
Investigating the effect of using a water-soluble probiotic supplement in the form of mouthwash on periodontal indicators and common bacteria that cause periodontal diseases after scaling and leveling the root surface in patients with moderate to severe chronic periodontitis
Design
a simple accidentTwo arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Place of study: Birjand Dental College
Participants/Inclusion and exclusion criteria
Age range from 20 to 60 years, no smoking, no pregnancy or breastfeeding, complete general health including no systemic infection and diabetes, autoimmune diseases and immunodeficiency disorders, no history of periodontal treatment in the last 6 months, no antibiotic use, no Taking NSAID drugs and not taking coronet during the last 3 months, suffering from moderate to severe chronic generalized periodontitis, which means having a CAL of 3 mm or more in more than 30% of the mouth, having a periodontal pocket with a depth of 4 mm or more Exclusion criteria: presence of systemic disease (lactose intolerance and immune deficiency disease, etc.), failure to return for re-examination at the end of the study
Intervention groups
A treatment, i.e., the etiotropic phase, which includes SRP and health education in one session for patients, and prescribing capsules containing probiotics for one group of two groups of patients and placebo capsules for the other group. (use as mouthwash for 14 days)
Main outcome variables
BOP bleeding index, PPD pocket depth, loss of CAL clinical connections, GI gingival index, PI plaque index, bacterial abundance, CPI index, OHIS index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240614062134N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: registered_while_recruiting

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Mohammad Hasanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3220 7068
Email address
sezavarkimia@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using a water-soluble probiotic supplement in the form of mouthwash on periodontal and gingival indicators and common pathogenic bacteria that cause periodontal diseases after scaling and leveling the root surface in patients with moderate to severe chronic periodontitis
Public title
Investigating the effect of using probiotic supplements in patients with moderate to severe chronic periodontitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Not smoking, making sure not to be pregnant or breastfeeding, complete general health including not havingSystemic infection and diabetes, autoimmune diseases and immunodeficiency disorders, no history of periodontal treatment in the last 6 months, no use of antibiotics, no use of NSAID drugs and no use of corticosteroids in the last 3 months, moderate to severe chronic generalized periodontitis means having CAL 3 mm and more in more than 30% of the mouth areas, having a periodontal pocket with a depth of 4 mm and more
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 38
More than 1 sample in each individual
Number of samples in each individual: 3
Each sampling time has a sample of dental plaque
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization In this method, we assign a number to each patient and randomly divide the patients into control and experimental groups based on the selection of numbers, and the people have no knowledge of their group.
Blinding (investigator's opinion)
Single blinded
Blinding description
After selecting the patients with moderate to severe chronic generalized periodontitis based on the inclusion criteria and the number of samples, they are randomly divided into two groups. Then, the necessary explanations are given to the patients verbally and in writing. They are not given information about being in the control group or the study group, and we will start collecting information on periodontal indicators and microbiological samples of each patient.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.BUMS.REC.1402.490

Health conditions studied

1

Description of health condition studied
Moderate to severe chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Percentage of people with moderate to severe chronic periodontitis
Timepoint
Measurement of indices and bacteria at the beginning of the study (before the start of the intervention) 14 and 28 days after the start of mouthwash use
Method of measurement
Laboratory studies and clinical evaluation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The probiotic capsule with the brand name FamilLact contains 7 useful probiotic species (CFU109).Lactobacillus species: Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus ramensus, Lactobacillus bulgaricus as probiotics in the family. Bifidobacterium species: Bifidobacterium bro, Bifidobacterium longum. Streptococcus species:Streptococcus thermophilus. Patients should use probiotic mouthwash or placebo for 14 days by dissolving two probiotic capsules in 250 cc of water and then gargling in the mouth for 30 to 60 seconds after cleaning the mouth with a toothbrush and dental floss.Avoid eating and drinking for 2 hours after rinsing with mouthwash.
Category
Treatment - Drugs

2

Description
Control group:Placebo capsules are administered to the other group. (use as mouthwash for 14 days)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand Faculty of Dentistry
Full name of responsible person
Mohammad Hasanzadeh
Street address
South Khorasan, Birjand, Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Mohammad1379hnz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Hasanzadeh
Street address
South Khorasan, Birjand, Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Mohammad1379hnz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohammad hasanzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
South Khorasan, Birjand, Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Mohammad1379hnz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad hasanzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
South Khorasan, Birjand, Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Mohammad1379hnz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad hasanzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
South Khorasan, Birjand, Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Mohammad1379hnz@gmail.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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