The comparison between the effect of the Hajji's Spray and chlorhexidine spray on the control of dental plaque : a Randomize Triple-Blind Controlled Phase-IIB Trial
The aim of this clinical trial was to evaluate the efficacy of a new formula named “Hajji's spray" in controlling the dental plaque formation in comparison to the chlorhexidine spray as a gold standard.
Methods. Design: A randomized, triple-blind, cross-over clinical trial employed two 5-day trial periods without mechanical oral hygiene intervention. Participants: In total 26 employee between 21 to 45 years old from 35 volunteers (mean age 26±7.2 years). Intervention: Hajji's spray (intervention) and chlorhexidine spray (active control), was used twice daily (morning at awaking and evening before retiring). A 7-day washout–period was used between trial periods. Main outcome measures: Turesky modification of Quigly and Hein index was used to assess plaque formation. At the end of each test period, subjects were asked to evaluate the taste used products.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112188453N1
Registration date:2012-01-19, 1390/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-19, 1390/10/29
Registrant information
Name
Mohamadreza Abrishami
Name of organization / entity
Dental School of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2212 3112
Email address
mr_abrishami@dent.sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Research Center Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-01-05, 1389/10/15
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effect of the Hajji's Spray and chlorhexidine spray on the control of dental plaque : a Randomize Triple-Blind Controlled Phase-IIB Trial
Public title
Anti-Plaque Efficacy of the Hajji's Spray
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: having at least 24 teeth Exclusion criteria: removable denture ; orthodontic appliance ; periodontal pocket grater than 4 mm ; attachment loss grater than 2 mm ; having pothological lesion ; medical or dental historical complication
Age
From 21 years old to 46 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental Research Center Shahid Beheshti University of Medical Sciences
Street address
Dental Research Center Shahid Beheshti University of Medical Sciences, Evin, Tehran.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
01-27-395
Health conditions studied
1
Description of health condition studied
Microbial Dental Plaque
ICD-10 code
k05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
assesment of dental plaque
Timepoint
at the beginning of study and 5 days after intervention
Method of measurement
Turesky modification of Quigley and Hein index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Hajji's spry
was used twice daily (morning at awaking and evening before retiring)
Category
Prevention
2
Description
Intervention group 2: Chlorhexidine Spray
was used twice daily (morning at awaking and evening before retiring)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
Dental School of Shahid Beheshti University of Medical Sciences, Evin, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental School of Shahid Beheshti University of Medical Sciences.
Full name of responsible person
mrs.zoghi
Street address
Dental School of Shahid Beheshti University of Medical Sciences, Evin, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School of Shahid Beheshti 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 School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farahnaz Fahimipour
Position
Dentistry student
Other areas of specialty/work
Street address
Dental School of Shahid Beheshti University of Medical Sciences, Evin, Tehran.
City
Tehran
Postal code
Phone
+98 21 2212 3112
Fax
Email
farahnaz_1366@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamadreza Abrishami
Position
assistant professor
Other areas of specialty/work
Street address
Dental School of Shahid Beheshti University of Medical Sciences, Evin, Tehran.
City
Tehran
Postal code
Phone
+98 21 2241 3897
Fax
Email
mr_abrishami@dent.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Farahnaz Fahimipour
Position
Dentistry student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 2212 3112
Fax
Email
farahnaz_1366@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)