The aim of this study was to evaluate the effect of mouthwash containing probiotic Lactobacillus salivarius NK02 on mild to moderate chronic periodontitis.
Design
thriple blind clinical trial , Control group with factorial and randomized groups by random allocation rule , 42 patients with mild to moderate chronic periodontitis
Settings and conduct
Patients will be examined first and if they have mild to moderate chronic periodontitis they will receive written consent. Patients are then fully scaling and braced. After that mouthwash is administered. 10 ml of the mouthwash is used twice daily for 1 minute 30 minutes after brushing for up to 1 month. All patients should be referred for re-examination and treatment results.
Participants/Inclusion and exclusion criteria
42 patients were selected from patients diagnosed with mild to moderate chronic periodontitis using radiologic and clinical findings. Written consent was obtained from patients.
Intervention groups
Probiotic mouthwash.
Chlorhexidine mouthwash.
Placebo mouth wash (normal saline). control
Main outcome variables
Modified Gingival Index (MGI)
bleeding on probing (BOP)
Probing depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191002044957N1
Registration date:2020-02-11, 1398/11/22
Registration timing:registered_while_recruiting
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Faezeh Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 2772
Email address
faezeakbari1375555@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lactobacillus salivarius NK 02 probiotic mouthwash on mild to moderate chronic periodontitis
Public title
Effect of probiotic mouthwash on chronic periodontitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Referred to Periodontics Department of Zahedan Dental School, with Mild to Moderate Chronic Periodontitis
The presence of envelopes between 3 and 7 mm
Patient satisfaction
Full public health
The presence of at least 20 teeth in the mouth
Lack of systemic disease (lactose intolerance, immunodeficiency disease, etc.)
Lack of dry mouth
Not taking any medication that affects the amount and quality of saliva
No antibiotic use in the last 3 months
No use of immunosuppressants in the past 6 months
No smoking and other tobacco products
Absence of pregnancy and lactation
Non-use of other probiotic products
Non-receive periodontal treatment in the last 6 months
Exclusion criteria:
Participant's unwillingness to continue treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Forty-four patients were randomly divided into three groups (n = 14).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Probiotic mouthwashes, chlorhexidine and normal saline mouthwashes are packaged in similar containers and labeled and coded in groups (A), (B) and (C). The codes for each container are unknown to the patient, therapist (student) and analyzer and will be kept confidential until the end of the study by the supervisor. Patients were randomly divided into three groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.ZAUMS.REC.1398.371
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Probing Depth
Timepoint
Immediately before us of mouthwash / one month later / three months later
Method of measurement
Measured by Williams probe
2
Description
Modified Gingival Index
Timepoint
Immediately before us of mouthwash / one month later / three months later
Method of measurement
Measurement by clinical examination
3
Description
Bleeding On Probing
Timepoint
Immediately before us of mouthwash / one month later / three months later
Method of measurement
Clinical observation of post-probing bleeding by Williams probe
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 10 ml of placebo mouthwash(Normal Saline) is used twice a day for 1 minute, 30 minutes after brushing for up to 1 month.
Category
Placebo
2
Description
Intervention group: 10 ml of probiotic mouthwash is used twice a day for 1 minute, 30 minutes after brushing for up to 1 month.
Category
Treatment - Drugs
3
Description
Intervention group: 10 ml of Chlorhexidine mouthwash is used twice a day for 1 minute, 30 minutes after brushing for up to 1 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dental School Periodontology Section
Full name of responsible person
Faezeh Akbari
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
Arbabi.Parvin@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Zahedan University of Medical Sciences
Full name of responsible person
Dr Nor Mohammad Bakhshani
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
Arbabi.Parvin@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sanaz Isar
Position
B.Sc., Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Library and Medical Information
Street address
Azadegan Shargi St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 5705
Fax
+98 54 3241 4003
Email
Faezeakbari1375555@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parvin Arbabi Kalati
Position
متخصص جراحی لثه
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
Arbabi.Parvin@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Faezeh Akbari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
Email
Faezeakbari1375555@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