Comparison of calcium and calcium placebo pre-rinse effect on salivary and plaque fluoride and calcium concentrations after the use of 900 ppm sodium fluoride mouthwash
The purpose of this study was to evaluate fluoride and calcium concentrations in saliva and dental plaque after the use of calcium pre-rinse and 900 ppm fluoride mouthwash. Inclusion criteria was good oral hygiene; having at least 24 natural teeth; normal unstimulated whole saliva flow rate; good oral and general health, no dentures and orthodontic appliances and no medications for at least 4 weeks before the project started. In this double-blind, double-crossover clinical trial, 30 dental students will participate. After prophylaxis and oral hygiene practices for 14 days by using non-fluoride products, the first baseline salivary and plaque sampling will be done. Immediately after that, based on a random number sequence, 15 subjects will use 10 ml placebo rinse/10 ml sodium fluoride and the remaining will use 10 ml calcium rinse /10 ml sodium fluoride. One and 12 hours later, samples will be again collected. The subjects then will receive another prophylaxis. Also, they will entirely adhere to previous 2 weeks pre-rinsing instructions. The second baseline samples will then gathered. Afterward, the participants will rinse treatment not previously used. The volume, time, order and duration of rinsing and salivary and plaque sampling (1 and 12 hours samples) will be as the same as explained before. The fluoride and calcium concentration in prepared specimens will be analyzed using an inverted fluoride selective electrode apparatus and atomic absorption spectrophotometry respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404286105N3
Registration date:2014-06-01, 1393/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-01, 1393/03/11
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
Zahedan University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of calcium and calcium placebo pre-rinse effect on salivary and plaque fluoride and calcium concentrations after the use of 900 ppm sodium fluoride mouthwash
Public title
Comparison of calcium and calcium placebo pre-rinse effect on salivary and plaque fluoride and calcium concentrations after the use of 900 ppm sodium fluoride mouthwash
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Good oral hygiene which was checked clinically by the absence of food debris and plaque accumulations; having at least 24 natural teeth; normal unstimulated whole saliva flow rate (0.25-0.35 ml/min); good oral (no demineralized enamel, no congenital enamel anomaly, no untreated decay, no faulty dental restorations) and general health
Exclusion criteria: Dentures and orthodontic appliances; Medications for at least 4 weeks before the project started.
Age
From 18 years old to 24 years old
Gender
Male
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Daneshgah Street, Zahedan
City
Zahedan
Postal code
Approval date
2011-02-23, 1389/12/04
Ethics committee reference number
6318
Health conditions studied
1
Description of health condition studied
Dental Caries
ICD-10 code
B99-B99
ICD-10 code description
Other infectious diseases
Primary outcomes
1
Description
salivary calcium concentration
Timepoint
1 and 12 hours after intervention 1 and 2
Method of measurement
by spectrophotometry
2
Description
salivary fluoride concentration
Timepoint
1 and 12 hours after intervention 1 and 2
Method of measurement
using fluoride selective electrode
3
Description
dental plaque fluoride concentration
Timepoint
1 and 12 hours after intervention 1 and 2
Method of measurement
using fluoride selective electrode
4
Description
dental plaque calcium concentration
Timepoint
1 and 12 hours after intervention 1 and 2
Method of measurement
by spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: 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 minute.
Category
Prevention
2
Description
Intervention 2: Distilled water mouthwash (Iran,), 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 minute.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Nahid Ramazani
Street address
Dental School, Azadegan Avenue, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nahid Ramazani
Street address
Zahedan University of Medical Sciences, Daneshgah Street, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Nahid Ramazani
Position
Aisstant Professor
Other areas of specialty/work
Street address
Dental School, Azadegan Avenue, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1242 3218
Fax
Email
ramazani_nahid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nahid Ramazani
Position
Pedodontist
Other areas of specialty/work
Street address
Dental School, Azadegan Avenue, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1242 3218
Fax
Email
ramazani_nahid@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)