Clinical Trails, Randomized control, double Blind, sample size 24 person, single center
Settings and conduct
this clinical study will be conducted in Islamic Azad university of Tehran and Shahid beheshty university of Tehran. the trail will be randomized and blinded and only the investigator alert about grouping and distribution of probiotics and placebos
Participants/Inclusion and exclusion criteria
patients have to have atleast 12 teeth , atleast one of tooth in each quadrant has (5-7mm) pocket , gingival index >2 & attachmant loss >1mm radiographic evidence of bone loss.
Intervention groups
The effect of Probiotic Lozenges and compare the effect with placebo
clinical, microbiological and IL-6 evaluation of probiotic lozenges in patients with chronic periodontitis
Public title
probiotics in the treatment of patient with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient have to have atleast 12 teeth
atleast one of the tooth in each quadrant has (5-7mm) pocket
gingival index >2 in each quadrant
clinical attachmet loss >1mm
radiographic evidence of bone loss
Exclusion criteria:
patients with systemic disease
patients who were pregnant , lacking , smokers
patients who had undergo periodontal or antibiotic treatment
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
simple
Blinding (investigator's opinion)
Double blinded
Blinding description
the participant will be divided into case and control groups. the outcome assessor will coded and distributed placebos between the participants. the coded finding the will be statistically analysed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee_faculty of dentistry , Tehran Medical Sciences , Islamic Azad University, Tehran
Street address
Neyesstan st , pasdaran
City
TEHRAN
Province
Tehran
Postal code
19585175
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.011
Health conditions studied
1
Description of health condition studied
chronic periodontitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Prevotella intermedia. Actinomycetemcomitans A. P.gingivalis.IL-6.gingival index. plaque index. clinical attachment loss
Timepoint
base line ,1 & 3 months
Method of measurement
plaque index by Sliness and LEO. gingival index by Leo and Sliness . attachment loss and pocket depth by william prob, Prevotella intermedia, Porphyromoas gingivalis. Actinomycetemcomitans A. by PCR & Real time PCR. IL-6 BY ELISA TEST
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Control group: Placebo group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic azad university of tehran
Full name of responsible person
Hedieh Ghandi
Street address
Neyestan 9- pasdaran
City
tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
drhediehghandi36@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Islamic azad university of tehran
Street address
neystan 9 st. pasdaran st
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Mahiran99@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr mahmood Ghasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
neyestan 9- pastadan st
City
tehran
Province
Tehran
Postal code
1946853314
Phone
002122454571
Email
mahiran99@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
hedieh ghandi
Position
resident
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
neyestan 9. pasdaran
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drhediehghandi36@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
DR.Mahmoud Ghasemi
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Neystaan 9. Pastadarn
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
mahiran99@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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