Effect of chewing gum containing CPP-ACP on salivary concentration of calcium , phosphate and alkaline phosphatase in 7-11 years old children with severe caries
aim:Effect of chewing gum containing CPP-ACP on salivary concentration of calcium , phosphate and alkaline phosphatase in 7-11 years old children with severe caries;
Inclusion criteria: No caries in the first group, tooth decay at least 6 to Group II; Exclusion criteria: Any repeort of systemic diseases, History of radiotherapy and chemotherapy,Anticholinergic drugs;The study population: 64 7-11 years old children, sample size:64 ;studied interventions:gum containing CPP-ACP,caries; The main outcome variable:concentration of calcium , phosphate and alkaline phosphatase
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062528624N1
Registration date:2016-07-15, 1395/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-15, 1395/04/25
Registrant information
Name
Avin Fattahi
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4053
Email address
a.fattahi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Isfahan (Khorasgan)
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-14, 1394/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of chewing gum containing CPP-ACP on salivary concentration of calcium , phosphate and alkaline phosphatase in 7-11 years old children with severe caries
Public title
Effect of chewing gum on saliva materials in children with severe caries
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: No caries in the first group; tooth decay at least 6 to Group II. Exclusion criteria: Any repeort of systemic diseases; History of radiotherapy and chemotherapy; Anticholinergic drugs; Lack of cooperation during the study; Using medication within 2 hours before sampling
Age
From 89 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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 University of Isfahan (Khorasgan), Dental School
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
IR.mui.rec.1394.4.23
Health conditions studied
1
Description of health condition studied
salivary concentration of calcium , phosphate and alkaline phosphatase
ICD-10 code
Z01.2
ICD-10 code description
Dental examination
Primary outcomes
1
Description
calcium
Timepoint
5 and 20 minutes after chewing gum
Method of measurement
with laboratory analysis
2
Description
phosphate
Timepoint
5 and 20 minutes after chewing gum
Method of measurement
with laboratory analysis
3
Description
alkaline phosphatase
Timepoint
5 and 20 minutes after chewing gum
Method of measurement
with laboratory analysis
Secondary outcomes
1
Description
calcium
Timepoint
5 and 20 minutes after chewing gum
Method of measurement
with laboratory analysis
Intervention groups
1
Description
Intervention: trident gum, 20 minutes of chewing,Sampling 5 minutes after chewing gum
Category
Diagnosis
2
Description
Control: Intervention: trident gum, 20 minutes of chewing,Sampling 5 minutes after chewing gum
Category
Diagnosis
3
Description
Intervention: trident gum, 20 minutes of chewing,Sampling 20 minutes after chewing gum
Category
Diagnosis
4
Description
control: trident gum, 20 minutes of chewing,Sampling 20 minutes after chewing gum
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
َAvin Fattahi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
Full name of responsible person
dr Vahid Esfahanian
Street address
Islamic Azad University of Isfahan (Khorasgan), Dental School
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Islamic Azad University 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
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Avin Fattahi
Position
Pediatric Dentistry/phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4053
Fax
Email
a.fattahi@khuisf.ac.iravinfattahi64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Avin Fattahi
Position
Pediatric Dentistry/phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4053
Fax
Email
a.fattahi@khuisf.ac.iravinfattahi64@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university Isfahan (Khorasgan)
Full name of responsible person
Avin Fattahi
Position
Pediatric Dentistry/phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4053
Fax
Email
a.fattahi@khuisf.ac.iravinfattahi64@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)