Protocol summary

Summary
Aim: To determine the amounts of fluoride ion release following using persica chewing gum and sodium fluoride chewing gum. Methods: 44, 20-30 year- old subjects will be selected randomly with regard to inclusion criteria: normal salivary flow rate, using no medications, using no systemic / topical fluoride (except tooth paste), excessive tea drinking habit and persica mouthwash users. The subjects will be asked to sign an informed consent. For one week, they will refrain from drinking tea and will use toothpaste with similar fluoride concentration (Running Period). All the participants, the practitioner and Lab technician will be blind during all the steps of the trial about the type of chewing gum used and saliva samples, respectively. This triple blind cross over study will be performed twice with ten-day interval (washout phase). Both types of chewing gum have the same amount of fluoride, color, shape and taste and will be synthetized by one chemist. During both phases of trial, saliva samples will be collected under controlled conditions at similar times in the morning within baseline, 5, 10, 20, 45 min. intervals following 5 min. chewing the gums. After labelling each container with code and date, the samples will be weighted and stored at -18℃ until fluoride analysis. Saliva flow rate (ml ⁄min) and mean fluoride concentrations during different periods and using different chewing gums will be compared and results will be disseminated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091810872N1
Registration date: 2012-12-26, 1391/10/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-26, 1391/10/06
Registrant information
Name
Mehrnoosh Babaee
Name of organization / entity
Dental College of Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2891
Email address
mehrnoosh_babaee@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of dental college of Isfahan University of Medical Sciences
Expected recruitment start date
2012-11-10, 1391/08/20
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Persica chewing gum versus sodium fluoride chewing gum on salivary fluoride concentration in 20-30 years old dental students of Isfahan University
Public title
Evaluation of fluoride released from persica chewing gum compared to sodium fluoride chewing gum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 20-30 year- old dental students who are systematically healthy; good oral hygiene; Normal salivary flow rate; Using no medication; Using no systemic or local fluoride supplements (except tooth paste); Not smoking exclusion criteria: Any repeort of systemic/oral diseases during studying phases; Excessive tea drinking; Using medication; Using Persica / fluoride mouthwashes; Smoking
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research of Dental College of Isfahan university of Medical Sciences
Street address
Dental College, Isfahan University of Medical Sciences, Azadi square(Darvazeh Shiraz), Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2012-11-05, 1391/08/15
Ethics committee reference number
391307

Health conditions studied

1

Description of health condition studied
The mean of saliva fluoride concentration following using persica chewing gum
ICD-10 code
Z01.2
ICD-10 code description
Dental examination

Primary outcomes

1

Description
Salivary Fluoride ion
Timepoint
Before intervention, 5, 10, 20, 45 min after intervention
Method of measurement
Mean fluoride ion released in terms of ppm and with laboratory analysis

Secondary outcomes

1

Description
Stimulated salivary flow rate
Timepoint
Before intervention, 5, 10, 20, 45 min after intervention
Method of measurement
Mean Stimulated salivary flow rate in terms of ml/min with laboratory analyze

Intervention groups

1

Description
Intervention group: chewing Persica, 750 mg gum, once, 5 minutes
Category
Prevention

2

Description
Control group: chewing sodium fluoride, 750 mg gum, once, 5 minutes
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Shiva Mortazavi-Pediatric Dentist-Assisstant professor
Street address
Isfahan university, Azadi square(Darvazeh Shiraz), Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Omid Savabi-Vice chancellor for research chief of Dental College of Isfahan University of Med
Street address
Vice chancellor for research, Dental College, Isfahan University, Azadi square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
391307
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Dental College of Isfahan University of Medical Sciences
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
Ddental college of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Shiva Mortazavi
Position
Pediatric Dentist, Assisstant Professor
Other areas of specialty/work
Street address
Dental College, Isfahan University of Medical Sciences, Azadi square(Darvazeh Shiraz), Isfahan
City
Isfahan
Postal code
8174673461
Phone
+998 3117922891
Fax
+98 31 1668 7080
Email
sh_mortazavi@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Shiva Mortazavi
Position
Pediatric Dentist, Assisstant Professor
Other areas of specialty/work
Street address
Dental College, Isfahan University of Medical Sciences, Azadi square(Darvazeh Shiraz), Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2891
Fax
+98 31 1668 7080
Email
sh_mortazavi@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Mehrnoosh Babaee
Position
General Dentist, Pediatric dentisty Resident
Other areas of specialty/work
Street address
Dental College, Isfahan University of Medical Sciences, Azadi square(Darvazeh Shiraz), Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2891
Fax
+98 31 1668 7080
Email
mehrnoosh_babaee@dnt.mui.ac.ir mdmasiha@yahoo.com
Web page address
www.dnt.mui.ac.ir

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
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