Objective of the study: a comparison between the impact of probiotic yoghurt and xylitol-containing chewing gum on the reduction of Streptococcus mutans of saliva.Study design: randomized clinical trial .Population: selected among the resident students in female dormitory of Islamic Azad University of khorasgan.Inclusion criteria: lack of any systemic diseases, having ≥150 forming units of Streptococcus mutans colony in 1 ml of saliva .Exclusion criteria: use of any types of antibiotics and medications containing corticostroide and antibacterial mouthwash and topical Fluoride (except Fluoridated toothpaste) 4 weeks before study starts, regular use of probiotic products and Xylitol-containing gums, smoking and taking contraceptive drugs.Sample size: 50 participants.Interventions: participants are randomly divided to 2 groups; group 1 will have probiotic yoghurt and group 2 will have xylitol gum . Intervention time:3 Weeks.Study implication: reducing Streptococcus mutans of saliva
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091319131N1
Registration date:2015-04-28, 1394/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-28, 1394/02/08
Registrant information
Name
Elnaz Ghasemi
Name of organization / entity
Dental school,Islamic Azad University Isfahan(khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4053
Email address
el.ghasemi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Isfahan(Khorasgan)
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-08-06, 1393/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of probiotic yogurt and gums containing xylitol on salivary mutans streptococcus reduction
Public title
comparison of the effect of probiotic yogurt and gums containing xylitol on salivary mutans streptococcus reduction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:absence of any systemic disease ;having 105≤ CFU/ml saliva levels of MS
Exclusion criteria: had not used antibiotics,cortons,antibacterial mouthwashes;topical fluride(except for fluoride toothpaste),within the 4-week prior to beginningof the study;used daily probiotics and xylitol-containing chewing gums ;person with smoking and used contraceptive drugs.
Age
From 73 years old to 58 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad Universityof Isfahan
Street address
Dental School,Islamic Azad Universityof Isfahan(khorasgan),Jey Street
City
Isfahan
Postal code
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
493040
Health conditions studied
1
Description of health condition studied
Amount of salivary streptococous mutans
ICD-10 code
A40.8
ICD-10 code description
Other streptococcal sepsis
Primary outcomes
1
Description
salivary mutans sterptococcus reduction
Timepoint
Befor study, immediately one day after complete use of probiotic yoghurt and Xylitol gum (3 weeks) and also 2 & 4 weeks after intervention
Method of measurement
First, saliva samples are cultured on specific medium (Mitis Salivarius Agar) using superficial culture method; eventually, the colonies are visually counted (based on the forming units of colonies in 1ml of saliva (CFU/ml))
Secondary outcomes
1
Description
reduction of dental caries
Timepoint
Before study and immediately one day after complete use of probiotic yoghurt and Xylitol gum (3weeks) and also 2 and 4 weeks after intervention
Method of measurement
ابتدا نمونه های بزاق روی محیط اختصاصی Mitis Salivarius Agar به روش کشت سطحی کشت داده خواهند شددر نهایت شمارش کلنی ها به روش چشمی انجام می شود(بر مبنای تعداد واحد تشکیل دهنده کلونی در1 میلی لیتربزاق CFU/ml).
Intervention groups
1
Description
Group 1: 200 cc probiotic yoghurt (Kaleh) daily,for 3 weeks, 10 min after dinner.
Category
Prevention
2
Description
Group 2: 3 times a day (after 3 meals) 2 pieces (1.86 gr Xylitol) at least for 5 min in a 3-week period Xylitol-containing chewing gum (ORION DR. XYLITOL)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
ِDental School,Islamic Azad University of Isfahan(Khorasgan)
Full name of responsible person
Elnaz Ghasemi
Street address
Dental School, Islamic Azad University Isfahan(Khorasgan), Jey Street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental School,Islamic Azad University of Isfahan(Khorasgan)
Full name of responsible person
Dr Vahid Esfahanian
Street address
Dental school,Islamic Azad Universityof Isfahan(Khorasgan),Jey street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School,Islamic Azad University of Isfahan(Khorasgan)
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
Postgraduated Student,Pediatric Dentistery
Full name of responsible person
Elnaz Ghasemi
Position
Postgraduate of Pediatric Dentistry
Other areas of specialty/work
Street address
Dental School,Islamic Azad Universityof Isfahan(khorasgan),Jey St