Protocol summary

Summary
Background and Aim : Evaluation of cariogenicity of snacks in children has special importance. The goal of this study is evaluation of 2 kinds of Iranian yogurts on plaque pH. Materials and Methods: In this randomized clinical trial study 10 healthy dental students will be selected upon entrance criteria such as, amount of saliva streptococcus mutans and lactobacilus, salivary secretion rate, Buffering capacity of saliva, absence of active dental caries, absence of systemic disease and …etc. Dental plaque pH in certain area of 4 mouth quadrants willbe taken by Ω Metrohm microelectrode and digital pH meter. before and after 2 to 60 minutes rinsing with plain yogurt, frouthy yogurt(apple) and 10% Sucrose solution. Then pH curve will be drawn according to time for each test product.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121910356N3
Registration date: 2012-12-23, 1391/10/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Paivand Moeini
Name of organization / entity
Islamic Azad University- Dental branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4572
Email address
p_moeini@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University- Dental branch
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of consumption effect of fruit yogurt ( apple) and plain yogurt on plaque pH
Public title
Evaluation of consumption effect of fruit yogurt ( apple) and plain yogurt on plaque pH
Purpose
Prevention
Inclusion/Exclusion criteria
Participants should have these criteria: no systemic disease; without previous history of antibiotic therapy from 2 weeks ago; not on special diet; without xerostomia; no applience or prostesis in mouth; not be smoker and pregnant; no periodontal disease,without active caries, without restoration on s aelected area(distal surface of 2th premolar and mesial surface offirst molar), besides they should not have GI restorations. Their stimulated salivary flow should be equal or more than 1ml/min and their salivary mutans stereptococci and lactobacilus count should be equel or more than 105 ml/CFU (determined by CRT-Bacteria Ivoclar-Vivadent); besides their salivary buffer capacity should be normal (determined by CRT-Buffer-Ivoclar-Vivadent).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University- Dental branch
Street address
#4- 1 floor pedodentistry department-10th Niestan-
City
tehran
Postal code
1946853314
Approval date
2012-08-01, 1391/05/11
Ethics committee reference number
پ/378/د

Health conditions studied

1

Description of health condition studied
dental caries
ICD-10 code
ko2
ICD-10 code description

Primary outcomes

1

Description
dental plaque pH
Timepoint
Before and 2, 5, 7, 10, 20, 30, 40, 50 and 60 minutes after consumption of exprimental drinks
Method of measurement
Dental plaque pH- microtouch microelectrode

Secondary outcomes

empty

Intervention groups

1

Description
intervension : consumption of 10 cc of fruit yogurt (apple ).
Category
Prevention

2

Description
intervention with consumption of 10cc plain yogurt willbe done.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University-dental branch
Full name of responsible person
paivand moeini
Street address
#4-1floor pedodentistry department-10th Niestan-Pasdaran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice- chancellery for research -IslamicAzad University - dental branch
Full name of responsible person
Dr. Arash Azizi
Street address
#4 -10th Niestan st-Pasdaran st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice- chancellery for research -IslamicAzad University - dental branch
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
Islamic Azad University
Full name of responsible person
paivand-moeiny
Position
assistant professor
Other areas of specialty/work
Street address
#4 - 1th floor- pediatric department -10 th niestan st -pasdaran
City
Tehran
Postal code
1946853314
Phone
+98 21 2256 4572
Fax
+98 21 8889 7505
Email
pmoeiny@yahoo.comp_moeiny@dentaliau.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
paivand moeiny
Position
assistant professor
Other areas of specialty/work
Street address
#4-1th floor pedodentistry department -10th Niestan-pasanchdaran
City
Tehran
Postal code
1946853314
Phone
0021982256572
Fax
+98 21 8889 7505
Email
pmoeiny@yahoo.com p_moeini@dentaliau.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
paivand moeiny
Position
assistant professor
Other areas of specialty/work
Street address
#4-1th floor-10th Niestan-pasdaran
City
tehran
Postal code
1946853314
Phone
+98 21 2256 4572
Fax
+98 21 8889 7505
Email
pmoeiny@yahoo.comp_moeini@dentaliau.ac.ir
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
Loading...