Aim: To compare the clinical effect of propolis toothpaste and regular toothpaste to prevent dental plaque formation. The study was double blind and crossover trial on 40 students carried out. Inclusion criterion: all persons have teeth and without periodontal disease. Exclusion criteria: individuals who have: orthodontic brackets and band; partial dentures; more than three crown in the mouth and 4 or more than 4 millimeter pocket in 4 quadrant. Twenty of case as first group brush with propolis toothpaste for 2 weeks and the same control as second group brush with traditional toothpaste (without propolis).after recording of plaque index ,The two groups don't do plaque control for 48 hours.Then ,The second group as case group brush with propolis toothpaste and first group as control use traditional toothpaste for 2 weeks.(crossover method). The primary outcome of the study is microbial plaque that with the method of o̓leary plaque index is recorded at baseline and 2 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060313576N1
Registration date:2013-07-17, 1392/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-17, 1392/04/26
Registrant information
Name
Majid Fereidooni
Name of organization / entity
Faculty of Dentistry, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
m.fereidooni@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol Faculty of Dentistry-babol medical science
Expected recruitment start date
2013-02-03, 1391/11/15
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of toothpaste with propolis in Prevention of microbial Plaque formation
Public title
The effect of propolis on the microbial plaque
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: all persons have teeth and without periodontal disease.
Exclusion criteria: individuals who have: orthodontic brackets and band; partial dentures; more than three crown in the mouth and 4 or more than 4 milimeter pocket in 4 quadrant.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not 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
Research and Technology Centre
Street address
University Research and Technology_Ganjafroz Street _babol
City
babol
Postal code
4717641367
Approval date
2013-01-22, 1391/11/03
Ethics committee reference number
2006/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Periodontal disease
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Microbial plaque
Timepoint
2 weeks after the intervention.
Method of measurement
O'Leary's Plaque Index
Secondary outcomes
empty
Intervention groups
1
Description
Using toothpaste with propolis in the first group for 2 weeks (two times a day).Then They don't use for 48 hours and then using normal toothpaste for 2 weeks (two times aday)
Category
Treatment - Other
2
Description
Using normal toothpaste in the second group for 2 weeks (two times a day).Then they don't use for 48 hours and then using toothpaste with propolis for 2 weeks (two times aday)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Faculty of Dentistry
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant (Research and Technology), Babol University of Medical Sciences
Full name of responsible person
Dr. Amrolah Mostafa Zadeh
Street address
Research and Technology, Babol University of Medical Sciences_Ganjafroz Street _babol
City
babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant (Research and Technology), Babol 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
Babol Faculty of Dentistry
Full name of responsible person
Dr. Majid Fereidooni
Position
Periodontist
Other areas of specialty/work
Street address
Faculty of Dentistry of Babol Medical Science - Ganjafroz Street - Babol
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
+98 11 1229 1408
Email
golpasha@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babo Faculty of Dentistry
Full name of responsible person
Dr. Majid Fereidooni
Position
Periodontist
Other areas of specialty/work
Street address
Faculty of Dentistry of Babol medical science - Ganjafroz Street -babol
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
+98 11 1229 1408
Email
golpasha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol Faculty of Dentistry
Full name of responsible person
Amineh Amiri
Position
Dental students
Other areas of specialty/work
Street address
Faculty of Dentistry of Babol Medical Science - Ganjafroz Street - Babol
City
Babol
Postal code
9178775154
Phone
+98 11 1229 1408
Fax
+98 11 1229 1408
Email
amine_amiri2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)