Protocol summary

Summary
Some patients with moderate to severe periodontitis will be selected from those who will come to Tehran university. Patients must have the following parameters: 1.PPD>= 4mm; 2.CAL>=3mm and 3.bone loss >=3mm. Exclusion criterion: 1.taking antibiotic over 3months ago; 2.immune deficiency disorders; 3.lactose intolerance and 4.taking immune suppressor drugs. First of all sample from saliva will be taken from 20 patien and transferred to the lab in ice-pack. In the lab probiotic of lactobacillus will be extracted from these samples and they will be tested against Aggrecatibacter actinomycetcomitans. The exteracted lactobacillus will be used as probiotic mouthwash during the next stages. After that patients will be selected and recorded for these periodontal criterion: Bleeding on Probing, Plaque index, Periodontal Pocket Depth, Periodontal disease index, Gingival index and taken the samples from whole saliva and periodontal pocket(the deepest one) to determine the amount of aggrecatibacter actinomycetcomitans.pocket samples will be taken by 3paper points for 30 seconds. After this stage,phase 1 periodontal therapy(scaling and root planning) will be done for the patients .after complement of this stage some probiotic and placebo mouthwashes (from all availaible contentsl in probiotic mouthwashe but bacteria )will be prescribed to the patients at random(balanced block randomization) for 4 weeks. (5cc bid) after that periodontal indexies and sampling from saliva and pockets will be recorded on 14th and 28th days and probiotic group will be compared to placebo one.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201258825N1
Registration date: 2012-08-20, 1391/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-20, 1391/05/30
Registrant information
Name
Neda Sajedi nejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 7768
Email address
akbari@nigeb.ac.ir
Recruitment status
Recruitment complete
Funding source
Terhan University of Medical Sciencs
Expected recruitment start date
2012-08-09, 1391/05/19
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of clinical and microbial effect of probiotics and phase 1 of periodontal treatment on patient with moderate to severe periodontitis in Tehran university in 1390
Public title
Evaluate the effect of probiotics and phase 1 of periodontal treatment on patient with moderate to severe periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: moderate to severe periodontitis and the presence of pockets more than 4mm. Patients must have the following parameters: 1.PPD>= 4mm; 2.CAL>=3mm and 3.bone loss >=3mm. Exclusion criterion: 1.taking antibiotic over 3months ago; 2.immune deficiency disorders; 3.lactose intolerance and 4.taking immune suppressor drugs.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical science
Street address
Tehran,Keshavarz BLV.Ghods AVN.Sazmane markazie daneshgah building.floor 5
City
Tehran
Postal code
0098
Approval date
2012-08-08, 1391/05/18
Ethics committee reference number
130/993/د/91

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
Gingival index
Timepoint
Day 0,14 and 28
Method of measurement
Prob

2

Description
Plaque index
Timepoint
Day 0,14 and 28
Method of measurement
Plaque staining

3

Description
Periodontal pocket depth
Timepoint
Day 0,14 and 28
Method of measurement
Prob

4

Description
Colony of Aggrebacter actinomycetcomitans
Timepoint
Day 0,14 and 28
Method of measurement
Colony count

5

Description
Bleeding on probing
Timepoint
Day 0,14 and 28
Method of measurement
Prob

6

Description
Periodontal disease index
Timepoint
Day 0,14 and 28
Method of measurement
Prob

Secondary outcomes

empty

Intervention groups

1

Description
Scaling and root planning and ُ probiotic mouth wash in case group
Category
Treatment - Drugs

2

Description
Scaling and root planning and placebo mouthwash in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school of Tehran university of medical science
Full name of responsible person
Dr.Neda Sajedi nejad
Street address
North amirabad.dental school of Tehran university
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental research center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojgan Paknejad
Street address
Dental Research Center, Dental Faculty,Tehran University of Medical Sciences.Ghods str.Engheleb Ave.Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental research center, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr Neda sajedi nejad
Position
PHD
Other areas of specialty/work
Street address
Dentistry university of Tehran
City
Tehran
Postal code
0098
Phone
+98 21 2213 7768
Fax
Email
neda_sajedi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
National institue of genetic and bioengeneering
Full name of responsible person
Dr Kambiz akbari
Position
PHD
Other areas of specialty/work
Street address
Hemmat gharb highway.Pajouhesh bulvar.National institue of genetic and bioengeneering
City
Tehran
Postal code
Phone
+98 21 2213 7768
Fax
Email
hakimehsharafi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr Neda sajedi nejad
Position
Resident of periodontology
Other areas of specialty/work
Street address
North amirabad.dental school of tehran university
City
Tehran
Postal code
Phone
+98 21 2213 7768
Fax
Email
neda_sajedi@yahoo.com hakimehsharafi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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