Protocol summary

Summary
Objectives: The aim of this study was to investigate whether salivary parameters including viscosity, flow rate, pH, and buffering capacity can be affected by the elimination of the existing active dental caries. Study design: 33 subjects between the ages of 6 and 12 years with more than 5 carious tooth surfaces were included in the study. An unstimulated saliva sample was obtained from each individual and the salivary characteristics including flow rate, viscosity, pH, and buffering capacity were evaluated. One month after performing a caries treatment procedure and eliminating all the existing dental caries, saliva sampling and analysis was performed again. inclusion criteria: children 6 to 12 years old; Caries-active having at least five decayed tooth surfaces exclusion criteria: having any systemic or local conditions affecting saliva quality and quantity; being on medications affecting the quality and quantity of saliva for the last six months; being under orthodontic therapy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071714032N1
Registration date: 2013-09-15, 1392/06/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-15, 1392/06/24
Registrant information
Name
Zahra Razavi Rohani
Name of organization / entity
Tabriz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5963
Email address
zahrarru@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2012-11-30, 1391/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of dental caries treatment on salivary parameters including flow rate, viscosity, PH and buffering capacity
Public title
evaluating the effect of dental caries treatment on salivary parameters
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: children 6 to 12 years old; Caries-active having at least five decayed tooth surfaces exclusion criteria: having any systemic or local conditions affecting saliva quality and quantity; being on medications affecting the quality and quantity of saliva for the last six months; being under orthodontic therapy
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
9261

Health conditions studied

1

Description of health condition studied
dental caries
ICD-10 code
K02
ICD-10 code description
dental caries

Primary outcomes

1

Description
salivary viscosity
Timepoint
before caries treatment
Method of measurement
Brookfield rotational viscometer

2

Description
salivary ph
Timepoint
before caries treatment
Method of measurement
digital ph meter

3

Description
salivary buffering capacity
Timepoint
before caries treatment
Method of measurement
ericsson method

4

Description
salivary flow rate
Timepoint
before caries treatment
Method of measurement
unstimulated saliva flow rate for 5 minutes

Secondary outcomes

empty

Intervention groups

1

Description
treatment of dental caries
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz dental faculty
Full name of responsible person
Dr. Naser Asl Aminabadi
Street address
Tabriz Dental Faculty, Golgasht St.
City
tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Department Of Tabriz University
Full name of responsible person
Dr Naser Asl Aminabadi
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department Of Tabriz University
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
Department Of Pediatric Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Zahra Razavi Rohani
Position
DDS, Postgraduate student
Other areas of specialty/work
Street address
Tabriz Dental Faculty
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
zahrarru@yahoo.com
Web page address

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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