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Comparing the effect of fluoride mouth rinse and calcium and fluoride mouth rinses on salivary fluoride concentration in dental students

Protocol summary

Summary
During topical fluoride application, fluoride ion can deposit CaF2 material on tooth surface. CaF2 forms a fluoride-releasing and PH-controlling system. Availability of calcium is an important factor for formation of this composition. Unfortunately during application of topical fluoridated products, formation of CaF2 deposits is limited due to low concentration of unbounded oral calcium in relation to applied amount of fluoride. The aim of this study is to evaluate the effect of calcium pre rinse on salivary fluoride concentration after a 900 PPM fluoride mouthwash. In this single blind randomized clinical trial, 42 female dental students with optimal oral hygiene, normal oral mucosal tissue and physiology, at least 20 teeth and suitable restorations and having no enamel defects, systemic diseases and active caries without wearing orthodontic appliances and prostheses, no using drugs affect quality and quantity of saliva and no using of antibiotics or antibacterial mouth rinses during 2 weeks ago will be randomly chosen and use sodium fluoride mouth rinse and after 2 weeks, calcium lactate and then immediately sodium fluoride rinses. Before each experiment, prophylaxis will be done and during the next 2 weeks, the participants will be asked no fluoridated products usage and then rinse with mouthwashes. Salivary samples will be taken immediately before, 1 and 12 hours after rinsing. Samples with coded numbers will be preserved in -20˚C and after collection of all, they will be transported to laboratory to preparation and analysis of fluoride ion, so that type of mouth wash and time of sampling will not be revealed in the laboratory. Determining salivary fluoride concentration will be done via fluoride sensitive electrode.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107306105N2
Registration date: 2011-09-17, 1390/06/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-09-17, 1390/06/26
Registrant information
Name
Nahid Ramazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 1341 6706
Email address
ramazani77@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sciences Vice chancellor for research, Zahedan University of Medical
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of fluoride mouth rinse and calcium and fluoride mouth rinses on salivary fluoride concentration in dental students
Public title
Use of calcium pre-rinse before fluoride mouth rinse
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: optimal oral hygiene; having normal oral mucosal tissue and physiology; having at least 20 teeth and suitable restorations Exclusion criteria: having enamel defects or systemic diseases; wearing orthodontic appliances or prostheses; active caries; using drugs affect quality and quantity of saliva; use of antibiotics or antibacterial mouth rinses during 2 weeks ago
Age
From 18 years old to 24 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Science
Street address
Pardis of Zahedan University of Medical Science, Khalij fars Avenue, Dr Hesabi Square,
City
Zahedan
Postal code
9816743463
Approval date
2011-02-15, 1389/11/26
Ethics committee reference number
3554-89

Health conditions studied

1

Description of health condition studied
the amount of salivary fluoride
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
salivary fluoride
Timepoint
immediately before, 1 and 12 hours after rinsing
Method of measurement
fluoride sensitive electrode

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: 0.2% NaF mouthwash (Behsa, Iran), 10 ml of mouth wash will be rinsed for 1 minutes.
Category
Prevention

2

Description
Intervention 2: 160 mmol/l calcium lactate mouthwash (Merk, Germany), 10 ml of mouth wash will be rinsed for 1 minutes. Immediately after that, 0.2% NaF mouthwash (Behsa, Iran), 10 ml of mouth wash will be rinsed for 1 minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Department of Zahedan Dental School
Full name of responsible person
Dr. Nahid Ramazani
Street address
School of Dentistry
City
Zahedan

2

Recruitment center
Name of recruitment center
Mojtama Khabgah
Full name of responsible person
Dr. Nahid Ramazani
Street address
Mojtama Khabgah- Dr Hesabi Square
City
Zahedan

3

Recruitment center
Name of recruitment center
Noor Khabgah
Full name of responsible person
Dr. Nahid Ramazani
Street address
Noor Khabgah- Mashahir Square
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sciences Vice chancellor for research, Zahedan University of Medical
Full name of responsible person
Dr Mahmud Zade Sagheb
Street address
Pardis of Zahedan University of Medical Science, Khalij Fars Avenue, Dr Hesabi Squre
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sciences Vice chancellor for research, Zahedan University of Medical
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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Nahid Ramazani
Position
Assistant professor of pediatric dentistry
Other areas of specialty/work
Street address
Dental School, Mehr Avenue
City
Zahedan
Postal code
9817699691
Phone
+98 54 1242 3218
Fax
+98 54 1241 4003
Email
ramazani@zaums.ac.ir;ramazani77@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nahid Ramazani
Position
Pedodontist
Other areas of specialty/work
Street address
School of dentistry, Mehr Avenue
City
Zahedan
Postal code
9817699691
Phone
+98 54 1242 3218
Fax
+98 54 1241 4003
Email
ramazani@zaums.ac.ir; ramazani77@gmail.com
Web page address

Person responsible for updating data

Contact

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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