The effect of Lactobacillus plantarum probiotic suspension on the plaque index (PI), gingival index (GI), bleeding on probing (BOP) and oral hygiene index (OHI) of patients with gingivitis
Design
Randomized, triple binded clinical trial with a parallel group design of 42 patients
Settings and conduct
his study will be carried out in the periodontology department of the Faculty of Dentistry of Mazandaran University of Medical Sciences. It is a triple blinded study(partients, analysor and researcher)
Participants/Inclusion and exclusion criteria
Inclusion criteria are plaque induced gingivitis(GI≥1) and presence of 20 teeth(5 teeth in each quadrant). Exclusion criteria are PD>3, pregnancy,lactating,systemic disease, antibiotics therapy in last 3 months, consumption drugs affecting gingival health, allergy, taking steroidals and nonsteroidals anti-inflammatory drugs, periodontal treatments in last 6 months, active caries, implants, crowns, orthodontic appliance and mouth breathing habbit.
Intervention groups
In this study, control group use the dextrose mouthwash and intervention group use probiotics mouthwash.
Main outcome variables
BOP; PI; GI; OH-s
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151017024573N7
Registration date:2019-04-07, 1398/01/18
Registration timing:registered_while_recruiting
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Mohadeseh Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
mheidari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of the probiotics suspension cantaining lactobacillus plantarum on gingivitis
Public title
effects of the probiotics suspension on gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
plaque induced gingivitis
presence at least 20 teeth
Exclusion criteria:
systemic disease
pocket depth>3
antibiotics therapy in last 3 months
consumption drugs affecting gingiva
periodontal treatment in last 6 month
active caries
orthodontic appliance
crowns/ implants
mouth breathing
pregnancy
allergies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, all patients, examiners, researchers, who perform data analysis are blind. Only a nurse who does not have any role in the research knows the type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.MAZUMS.REC.1396.2950
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Plaque Index
Timepoint
baseline,1,2 and 4 weeks after intervention
Method of measurement
probe
2
Description
Gingival Index
Timepoint
baseline,1,2 and 4 weeks after intervention
Method of measurement
probe
3
Description
Bleeding on Probing
Timepoint
baseline,1,2 and 4 weeks after intervention
Method of measurement
probe
Secondary outcomes
1
Description
Oral Hyegiene Index
Timepoint
baseline,1,2 and 4 weeks after intervention
Method of measurement
probe
Intervention groups
1
Description
Intervention group: lactobacillus salivarius probiotic mouthwash, two times a day for four weeks, immediately after brushing, rinse defined amount ( not swallow) for 1 minutes
Category
Treatment - Drugs
2
Description
Control group: placebo mouthwash, two times a day for four weeks, immediately after brushing, rinse defined amount ( not swallow) for 1 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Science,Sari Dental Faculty
Full name of responsible person
Mohadeseh Heidari
Street address
aculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3565 5939
Email
heidari_mohadeseh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farhad Sobouti
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895477
Phone
+98 11 3325 4135
Email
farhad_sobouti@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Ebrahimzadeh Hassanabadi
Position
dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895477
Phone
+98 11 3325 4134
Email
meeehran@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895477
Phone
+98 11 3325 4135
Email
heidari_mohadeseh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Ebrahimzadeh
Position
dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895477
Phone
+98 11 3325 4134
Email
meeehran@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