Protocol summary

Summary
The main purpose of this study was to compare stain indices following mouth washing with Chlorhexidine + PVP with Chlorhexidine. In this randomized, double blind study, 40 patients in Periodontology of Hamadan University of Medical Sciences were randomly assigned into intervention or control groups to use Chlorhexidine + PVP or Chlorhexidine mouth wash for 2 weeks, respectively. Plaque and gingival indices, bleeding on probing index, and stain index were assessed before and after the intervention and compare between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902053795N1
Registration date: 2010-06-04, 1389/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-04, 1389/03/14
Registrant information
Name
Hojatollah Yousefimanesh
Name of organization / entity
Ahvaz Junishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 0597
Email address
yousefimanesh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of tooth staining by use of polyvinylpyrrolidone (pvp) in composition with Chlorhexidine
Public title
Evaluation of tooth staining by use of polyvinylpyrrolidone (pvp) in composition with Chlorhexidine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: no hypersensitivity to chlorhexidine and/or PVP, not using antibiotic during 3 months prior to the study, no pregnancy, having orthodontic and removable appliances, no irreversible teeth staining, without crown and restoration at 12 anterior teeth, No smoking, mild to moderate gingival inflammation without attachment loss
Age
No age limit
Gender
Both
Phase
0
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
Ethnic committee of Hamadan University of Medical Science
Street address
Hamadan University of Medical Sciences, Mardom Park, Shahid Fahmide St., Hamadan
City
Hamadan
Postal code
Approval date
2010-01-19, 1388/10/29
Ethics committee reference number
154087/9/35/16/پ

Health conditions studied

1

Description of health condition studied
mild to moderate gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
stain index (lobene index)
Timepoint
Baseline and after 2 weeks
Method of measurement
0= no stain 1= light stain 2= moderate stain 3=heavy stain

Secondary outcomes

1

Description
Bleeding on probing (BOP)
Timepoint
Baseline and after 2 weeks
Method of measurement
Code 0 = no bleeding Code 1= bleeding

2

Description
plaque index (Silness & Loe) (PI)
Timepoint
Baseline and after 2 weeks
Method of measurement
0=no plaque,1=visible with probe,2=visible with eye,3=heavy plaque interdental filled with plaque

3

Description
gingival index (Silness & Loe GI)
Timepoint
Baseline and after 2 weeks
Method of measurement
0=Normal gingiva,1=Mild inflammation: slight change in color and slight edema. No bleeding on probing, 2=Moderate inflammation: redness, edema, and glazing. Bleeding on probing ,3=edema. Ulceration. Tendency toward spontaneous bleeding.

Intervention groups

1

Description
Chlorhexidine, mouth washing with 15cc mouth wash, 2 time a day at morninig and night, for two weeks
Category
Treatment - Drugs

2

Description
Chlorhexidine + PVP, mouth washing with 15cc mouth wash, 2 time a day at morninig and night, for two weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan University of Medical Science /Dentistry faculty
Full name of responsible person
Parviz Torkzaban
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mirzaei
Street address
Hamadan University of Medical Sciences, Mardom Park, Shahid Fahmide St., Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hojjat Yoosefimanesh
Position
Resident of Periodontology
Other areas of specialty/work
Street address
Periodontology department, Faculty Dentistry, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 916 671 1679
Fax
Email
yousefimanesh@umsha.ac.ir hojjatyoosefi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hojjat Yoosefimanesh
Position
Resident of Periodontology
Other areas of specialty/work
Street address
Periodontology department, Faculty Dentistry, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 916 671 1679
Fax
Email
hojjatyoosefi@yahoo.com
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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