Clinical trial The Effect of Probiotic Supplementation in the form of Mouthwash with Scaling and Root planing on the Periodontal Indeces in Patients with Generalized Chronic Periodontitis
This study aims to determine the Effect of Probiotic Supplementation in the form of Mouthwash with Scaling and Root planing on the Periodontal Indeces in Patients with Generalized Chronic Periodontitis
Design
36 patients with Chronic Generalized Periodontitis will be choosen and will be divided into two equal groups through simple randomization.
Settings and conduct
Probiotic and placebo supplements in the same packages (shape, size, and color that are almost the same). The supplements will be purchased from Milad Faramed company and will be available to patients.
Participants/Inclusion and exclusion criteria
Healthy patients aged 25-59 years old, with a average age of 45.3 years who are diagnosed with chronic periodontitis with at least 4 teeth indicating probing depth (PD) ≥ 5 mm, clinical attachment level (CAL) ≥4 mm will be choosen.
include criteria:
Patients suffering Chronic Generalized Periodontitis with a degree of Clinical adhesion of CAL≥4 who are systemically healthy.
Exclude criteria:
Patients with any systemic disease, that could affect periodontum disease
Sensitivity to probiotic supplements
Antibiotic therapies in the last 3 months
Pregnant and lactating women
Allergic patients to lactate products
Patients with inappropriate collaboration (High level of plaque index in the periodic examinations).
Intervention groups
The intervention group after SRP will use probiotic for 20 days by daily solution of two probiotic capsules in 250 cc in water and then will gargle in the mouth for 30 to 60 seconds to increase its local effect on the gum tissue.
Main outcome variables
Measuring the variables (Bleeding on probing, Probing depth, Clinical attachment loss, Plaque index) before scaling, and in the period of one month and three months after scaling.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180630040290N2
Registration date:2019-03-27, 1398/01/07
Registration timing:registered_while_recruiting
Last update:2019-03-27, 1398/01/07
Update count:0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Amir Reza Babaloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3428 3025
Email address
babalooa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial The Effect of Probiotic Supplementation in the form of Mouthwash with Scaling and Root planing on the Periodontal Indeces in Patients with Generalized Chronic Periodontitis
Public title
The Effect of Probiotic Supplementation in the form of Mouthwash with Scaling and Root planing on the Periodontal Indeces in Patients with Generalized Chronic Periodontitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering chronic generalized periodontitis with clinical attachment loss (CAL)≥4 millimeters who are systemically healthy.
Exclusion criteria:
Patients with any systemic disease, that could affect periodontium disease
Sensitivity to probiotic supplements
Antibiotic therapies in the last 3 months
Pregnant and lactating women
Allergic patients to lactate products
Patients with inappropriate collaboration (High level of plaque index in the periodic examinations)
Age
From 29 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization.
In this study, patients are assigned to one of two study groups using the random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Probiotic and placebo supplements are in the same packages (shape, size, and color that are almost the same). The supplements will be purchased from Milad Pharmed company and will be available to patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blv
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.TBZMED.REC.1397.912
Health conditions studied
1
Description of health condition studied
The effect of probiotic supplementation in the form of mouthwash with scaling and root planing on the periodontal indeces in patients with generalized chronic periodontitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical attachment level (CAL)
Timepoint
Before the intervention , one months after initiating the intervention and three months after initiating the intervention.
Method of measurement
measurement of the distance between the stent margin to the sulcus base by means of a periodontal probe.
2
Description
Plaque index (Pl)
Timepoint
Before the intervention , one months after initiating the intervention and three months after initiating the intervention.
Method of measurement
By disclosing agent with visual scale.
3
Description
Bleeding on probing (BOP)
Timepoint
Before the intervention , one months after initiating the intervention and three months after initiating the intervention.
Method of measurement
Bleeding in 15 seconds after gentle probing by periodontal probe.
4
Description
Probing depth (PD)
Timepoint
Before the intervention , one months after initiating the intervention and three months after initiating the intervention.
Method of measurement
The distance between the mucosal margin and the sulcus base by periodontal probe in millimeters.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group after SRP will use probiotic for 20 days by daily solution of two probiotic capsules in 250 cc water and then will gargle in the mouth for 30 to 60 seconds to increase its local effect on the gum tissue.
Category
Treatment - Other
2
Description
The control group after SRP will use placebo (drinking water that has been stablished in terms of chemical compounds).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Faculty of Dentistry of Tabriz
Full name of responsible person
Amirreza Babaloo
Street address
Dentistry Facaulty of Tabriz, Golgasht Ave, Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirrezababaloo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Central office No. 2, Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amirreza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
Amirrezababaloo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amirreza Babloo
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirrezababaloo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behnam Mohammadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
behnam.mhmdi739298@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