The aim of the study is to compare two pastes containing CPP-ACP and CPP-ACPF on dental plaque pH changes following sugar consumption.This study is designed as a randomized, double-blind trial. Forty 12-14 year old students are recruited and ordered not to eat or brush at least 2 hours prior to the intervention. After obtaining a dental plaque sample from the distal aspect of the first permanent molar for pH measurement, they will be given a %10 sucrose solution and after 10 minutes, another sample is taken for pH measurement. In the next stage, the students are randomly allocated to two study groups. The operator blindly applies a CPP-ACP paste to the teeth and a CPP-ACPF paste to the second. Plaque samples for pH measurements are collected again after 30 and 60 minutes and after 24,48, and 96 hours. These recordings shall be statistically analyzed with repeated measures ANOVA tests.
Comparing the effect of CPP-ACP and CPP-ACPF pastes on dental plaque pH changes after sugar consumption.
Public title
Comparing the effect of two different pastes on dental plaque pH changes and caries prevention after sugar consumption.
Purpose
Prevention
Inclusion/Exclusion criteria
40 male students with an average oral hygiene and plaque index of at least 10% which have neither eaten nor brushed for at least 2 hours prior to obtaining first plaque samples of the intervention.
Age
From 12 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block randomization with a block size of 4
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic azad universiyof dentistry ,Tehran
Street address
No. 4, Neyestan 10, Pasdaran,Tehran
City
Tehran
Postal code
Approval date
2011-12-11, 1390/09/20
Ethics committee reference number
د/768/پ
Health conditions studied
1
Description of health condition studied
Dental careis
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
pH of dental plaque
Timepoint
0, 10, 30, 60 minutes and 24, 48, 96 hours after
Method of measurement
Diagnostic pH plaque kit
Secondary outcomes
empty
Intervention groups
1
Description
A paste containing casein phosphopeptide amorphous calcium phosphate is applied on the tooth surface for 5 minutes after the patient has used a 10% sucrose solution ,followed by pH measurment
Category
Prevention
2
Description
A paste containing casein phosphopeptide amorphous calcium phosphate and 900ppm fluride is applied on the tooth surface for 5 minutes after the patient has used a 10% sucrose solution ,followed by pH measurment
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharazmi education centure
Full name of responsible person
Hadi abdian- Dentist
Street address
Shahid rajaie ave, Basij avenue, Charmardan ave
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor of research center of islamic azad dental university,Tehran
Full name of responsible person
Arash Azizi
Street address
Neyestan 10th, Pasdaran 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
Chancellor of research center of islamic azad dental university,Tehran
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 Dental University,Tehran
Full name of responsible person
Haleh heshmat
Position
Profissional Assistance
Other areas of specialty/work
Street address
No.8, 9th ave, Gaandi ave,Tehran
City
Tehran
Postal code
1465896473
Phone
+98 21 8887 8135
Fax
Email
h_heshmat@yahoo.com; h_heshmat@dentaliau.ac,ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad Dental University,Tehran
Full name of responsible person
Haleh Heshamat
Position
Profissional Assistance
Other areas of specialty/work
Street address
Restorative department of Islamic Azad Dental Univresity,Tehran
City
Tehran
Postal code
1465896473
Phone
+98 21 8887 8135
Fax
Email
h_heshmat@dentaliau.ac.ir; h_heshmat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad Dental University,Tehran
Full name of responsible person
Haleh Heshmat
Position
Profissional Assistance
Other areas of specialty/work
Street address
Neyestan 10, Pasdaran,tehran
City
Tehran
Postal code
1465896473
Phone
+98 21 8887 8135
Fax
Email
h_heshmat@dentaliau.ac.ir; h_heshmat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)