The objective of this study is to assess the plaque inhibitory action of a herbal-based toothpaste. 30 adult volunteers were recruited from students of Guilan University meeting the inclusion criteria and having at least 20 teeth with the maximum probing depth equal to 3 millimeters participate in this double-blind, cross-over, controlled clinical trial, based on a variation of a 4-day plaque regrowth model with a 3-day wash-out period. After professional tooth cleaning, subjects are asked to refrain from all mechanical hygiene measures for the next 96 hours and to use two rinses (1min) a day of either test (Paradontax) or control toothpastes as the only oral hygiene measure. At day 4, teeth are stained to assess the whole mouth plaque index (PI) using Tureskey modification of Quigly Hein PI, and to evaluate PI for anterior teeth, using a 10 scaled PI: New Method of Plaque Scoring (Dababneh et al). For the purpose of accuracy photographies are taken from anterior teeth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808191081N3
Registration date:2010-02-19, 1388/11/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-19, 1388/11/30
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Research secretory
Expected recruitment start date
2009-08-04, 1388/05/13
Expected recruitment end date
2009-11-02, 1388/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to assess the plaque inhibitory action of a herbal-based toothpaste: A double-blind controlled clinical trial
Public title
The inhibitory action of a herbal- based toothpaste on dental plaque.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having systemic health and periodontal health: Pocket probing depth no more than 3 mm, no bleeding on probing and/or gingival enlargement, having at least 20 scorable teeth
Exclusion criteria: having dental implants, orthodontic appliances or partial dentures, Drug consumption Particularly Antibiotics, smoking, dental crowding and/or mouth breathing habit.
Age
No age limit
Gender
Both
Phase
4
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
Not used
Assignment
Crossover
Other design features
In this study toothpastes are used as slurries which are made freshly by adding 3 mg toothpaste to 10 ml distilled water
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Research, Guilan University of Medical Sciences
Street address
Namjoo Blvd., GUMS Building
City
Rasht
Postal code
Approval date
2010-03-02, 1388/12/11
Ethics committee reference number
8507
Health conditions studied
1
Description of health condition studied
Dental-microbial plaque
ICD-10 code
KO5.1
ICD-10 code description
chronic gingivitis
2
Description of health condition studied
Dental-microbial plaque
ICD-10 code
KO5.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
plaque index for the entire dentition
Timepoint
4-day period
Method of measurement
Treskey modification of Quigly-Hein plaque index
Secondary outcomes
1
Description
Plaque index for anterior teeth
Timepoint
4-day period
Method of measurement
New method of plaque scoring
Intervention groups
1
Description
Parodontax(herbal-based) toothpaste slurry, two rinses (1min) a day
Category
Treatment - Other
2
Description
A commerical toothpaste slurry (with no herbal ingredients), two rinses (1min) a day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental research center and department of periodontics, faculty of dentistry
Full name of responsible person
Golpar Radafshar
Street address
Emam Khomeini Blv.opp.Pardis Hotel
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Faculty of Dentistry, Guilan University of Medical Sciences
Full name of responsible person
Nastaran Mirfarhadi
Street address
Opposite Pardis hotel, Emam Khomeini Blv.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Faculty of Dentistry, Guilan 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
Dental Research center, Faculty of Dentistry,Guilan University Of Medical sciences
Full name of responsible person
Nastaran Mirfarhadi
Position
MS Nursing Education/center secretary
Other areas of specialty/work
Street address
Emam Khomeini Blvd. Opp. Pardis Hotel
City
Rasht
Postal code
41887-94755
Phone
+98 13 1323 0775
Fax
+98 13 1323 0776
Email
nargol_farahani@yahoo.com
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of periodontics, Dental Research center,faculty of Dentistry,Guilan University of medical
Full name of responsible person
Golpar Radafshar
Position
Assistant professor in the department of periodontology/Head (Director) of dental research center
Other areas of specialty/work
Street address
Emam KHomeini Blv.Opp.Pardis Hotel
City
Rasht
Postal code
41887-944755
Phone
00981313230775-00981313220060
Fax
00981313230776-00981317757636
Email
golshad@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of periodontics, Dental Research center, Faculty of Dentistry, Guilan University of Medic
Full name of responsible person
Golpar Radafshar
Position
Assistant professor in the department of periodentology/Head of dental research center
Other areas of specialty/work
Street address
Emama khomeini Blv.Opp.Pardis hotel
City
Rasht
Postal code
41887-94755
Phone
+98 13 1323 0775
Fax
00981317757636-00981313230776
Email
golshad@gums.ac.ir
Web page address
www.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)