Protocol summary

Summary
A total of 20 subjects, (40 lesions), each with two initial caries, will be recruited. The two lesions in each subject will randomly be assigned for treatment with ozone and remineralization agent and only remineralization agent, in a double-blind design, in a general dental practice. Subjects will be recalled at 1st and 3rd months. The system used to evaluate the effect of ozone is DIAGNOdent. Enamel surfaces will be cleaned by profilaxy gel before using the equipment. Machine will be calibrated by use of healthy enamel.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809222844N1
Registration date: 2010-03-18, 1388/12/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-18, 1388/12/27
Registrant information
Name
Amir Mirmoezzi
Name of organization / entity
Shahid Beheshti dental university, Shahid Beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 2188070413225
Email address
aghasemi@dent.sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Shahid Beheshti dental university
Expected recruitment start date
2009-09-30, 1388/07/08
Expected recruitment end date
2010-01-31, 1388/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ozone on decalcified points OF ENAMEl
Public title
Effect of ozone on tooth
Purpose
Treatment
Inclusion/Exclusion criteria
Having active initial caries on both sides
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Council of Research Center of Shahid Beheshti dental university
Street address
Shahid Beheshti Dental university, Velenjak, TEHRAN, IRAN
City
Tehran
Postal code
Approval date
2009-12-08, 1388/09/17
Ethics committee reference number
م.ك.ا/8807

Health conditions studied

1

Description of health condition studied
Initial caries
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel White spot lesions [initial caries]

Primary outcomes

1

Description
Change of diagnodent number in patients
Timepoint
after 4 months
Method of measurement
diagnodent

Secondary outcomes

1

Description
Arresting or reversing the progression of dental caries
Timepoint
after 7 months
Method of measurement
by using diagnodent

Intervention groups

1

Description
Usage of ozotop unit (140ppm 12 seconds 2 Times) and remineralization agent for 3 minutes in intervention group
Category
Treatment - Devices

2

Description
Usage of remineralization agent in control group for 3 minutes
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti dental university
Full name of responsible person
Street address
Velenjak
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti dental university, Dental research center
Full name of responsible person
Dr.Seyed Mohammad Reza Safavi
Street address
Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti dental university, Dental research center
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
Shahid Beheshti dental university
Full name of responsible person
Seyed Amir Mirmoezzi
Position
Student
Other areas of specialty/work
Street address
Velenjak, Shahid Beheshti dental university
City
Tehran
Postal code
Phone
+98 2188070413225
Fax
Email
amirmirmoezzi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti dental university
Full name of responsible person
Dr.Amir Ghasemi
Position
Associate Professor
Other areas of specialty/work
Street address
Shaid Beheshti dental university, Velenjak
City
Tehran
Postal code
Phone
+98 21 8785 5625
Fax
Email
Amir-gh-th@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Seyed Amir Mirmoezzi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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