Fixed orthodontic patients with minimum 2 teeth with gingival hyperplasia and inflammation (without history of anticonvalsant ,antibiotic drugs and antibacterial mouthwashes during last 6 months , without presence of calcolous or bonding agent excess) are randomly allocated into 4 groups . Group 1(as control)- receive oral hygiene instruction , orthodontic toothbrush Oral B and toothpaste with 1450 ppm fluoride .2-the same as group 1 but receive power brush Oral B . 3- the same as group 1 and additionally get Persica mouthwash (according to manufacture instructions) .4- The same as group 3 but receive Cholorhexidine mouthwash. They do instructions for 2 weeks. Gingival & plaque indices , BOP and gingival hyperplastic index are measured at the start and at the end of study . ANOVA , Mann-whitney & Friedmann tests are used for analysis
General information
Acronym
persica vs cholorhexidine vs power brush
IRCT registration information
IRCT registration number:IRCT201202209086N1
Registration date:2012-04-30, 1391/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Nasrin Farhadian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 4017
Email address
farhadian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Dental faculty , Hamadan university of medical sciences,
Expected recruitment start date
2012-04-30, 1391/02/11
Expected recruitment end date
2013-04-30, 1392/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical improvement of gingival hyperplasia with mouthwashes cholorhexidine vs persica and powered brush in fixed orthodontic cases
Public title
Clinical improvement of gingival hyperplasia with cholorhexidine , persica and powered brush in fixed orthodontic cases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion :under fixed orthodontic treatment , minimum 2 teeth with gingival enlargement and inflammation.
Exclusion :history of anticonvalsant drugs , history of antibiotic therapy during last 6 months , history of recieving antibacterial mouthwashes during last 6 month , presence of calcolous or bonding agent excess.
Age
From 12 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research Center ,Hamadan University of Medical Sciences
Street address
Hamadan , blv. shahid fahmide ,Hamadan University of medical sciences
City
Hamadan
Postal code
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
4943/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Gingival enlargment
ICD-10 code
K06.1
ICD-10 code description
Gingival enlargement
Primary outcomes
1
Description
Bleeding on Probing(BOP)
Timepoint
Start at case selection phase , 2 weeks after treatment protocols
Method of measurement
According to indices descriptions using periodontal probs
2
Description
plaque index
Timepoint
Start at case selection phase , 2 weeks after treatment protocols
Method of measurement
According to indices descriptions using periodontal probs
3
Description
Gingival hyperplastic index
Timepoint
Start at case selection phase , 2 weeks after treatment protocols
Method of measurement
According to indices descriptions using periodontal probs
4
Description
Gingival index
Timepoint
Start at case selection phase , 2 weeks after treatment protocols
Method of measurement
According to indices descriptions using periodontal probs
Secondary outcomes
empty
Intervention groups
1
Description
Patient recieves toothbrush , toothpaste(control) , and oral hygiene instruction and requested to do instructions for 2 weeks.
Category
Treatment - Drugs
2
Description
Patient recieves powerde toothbrush , toothpaste , and oral hygiene instruction and requested to do instructions for 2 weeks.
Category
Treatment - Drugs
3
Description
Patient recieves toothbrush , toothpaste , and oral hygiene instruction and persica mouthwash requested to do instructions according to manufacture for 2 weeks.
Category
Treatment - Drugs
4
Description
Patient recieves toothbrush , toothpaste , and oral hygiene instruction and cholorhexidine mouthwash requested to do instructions according to manufacture for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Hamadan university ,Private orthodontic clinic
Full name of responsible person
Nasrin Farhadian
Street address
Dental school of Hamadan university , Shahid Fahmide Blvd.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research centre of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Hamedan University of Medical Sciences , shahid fahmide blvd.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research centre of Hamedan 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 faculty, Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadian
Position
associated professor
Other areas of specialty/work
Street address
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences , Shahid Fahmide blv.
City
Hamadan
Postal code
Phone
+98 81 1836 4017
Fax
Email
nasrinne@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty, Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadian
Position
associated professor
Other areas of specialty/work
Street address
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences , Shahid Fahmide blv.
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
nasrinne@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental faculty, Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadian
Position
Associated professor
Other areas of specialty/work
Street address
Dental faculty, Hamadan University of Medical Sciences , Shahid Fahmide blv.
City
Hamedan
Postal code
Phone
+98 81 1835 4017
Fax
Email
Farhadian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)