Determination and comparison of PI and GMSI indices before and after use in 5 groups with different Method of mouthwash
Design
The samples will consist of 50 patients referring to the department of dentistry.
After obtaining written consent, the teeth of the patients are ultimately scraped with ultrasonic instruments. The bass technique is taught to patients.
At this time, patients are randomly divided into 5 groups, patients are unaware of which groups they are and are considered to be the same for two mouthwashes. For blindness, we use coding for patients. Each group is trained to use mouthwashes.
Settings and conduct
Isfahan University of Medical Sciences and Dosso is blind
Participants/Inclusion and exclusion criteria
Entry criteria for studying having mild to moderate gingivitis, having at least 12 anterior teeth, and withdrawal criteria: presence of envelopes (> 5mm), use of orthodontic oral prosthesis or applicators, history of antibiotic use during For the past 3 months, smoking and systemic diseases that may affect their periodontal disease.
Intervention groups
Group 1: Use of chlorhexidine mouthwash in the morning - Afternoon hydrogen peroxide mouthwash - Chlorhexidine bleaching at night.
Group 2: Use chlorhexidine mouthwash and then immediately hydrogen peroxide in the morning - chlorhexidine and then immediately hydrogen peroxide at night.
Group 3: Use hydrogen peroxide mouthwash and then immediately chlorhexidine in the morning - hydrogen peroxide and then immediately chlorhexidine at night.
Group 4: Use of chlorhexidine mouthwash in the morning - Chlorhexidine mouthwash at night.
Group 5: Use of hydrogen peroxide mouthwash in the morning - Hydrogen Peroxide Mouthwash at Night.
Main outcome variables
Plaque and dental plaque
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101006004877N28
Registration date:2018-06-10, 1397/03/20
Registration timing:registered_while_recruiting
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of different treatment regimes of hydrogen proxide and chlorhexidine mouthrinses on dental stain and plaque
Public title
Evaluation of different treatment regimes of hydrogen proxide and chlorhexidine mouthrinses on dental stain and plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate periodontitis
Have at least 12 anterior teeth
Exclusion criteria:
Use orthodontic or prosthetic appliance
Smoking
Pocket depth more than 5
Attach loss more than 2
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Systemic randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Mouthwashes are delivered in unnamed packages and similar to the samples.
Each code sample is assigned and the person who measures the indexes does not know which groups are in the sample.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of esfahan University of Medical Sciences
Street address
Hezar harib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.mui.rec.1396.3.944
Health conditions studied
1
Description of health condition studied
Dental plaque and dental stain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
25/5000Plaque and dental plaque
Timepoint
1 and 4 weeks after entering the patient to study
Method of measurement
1-PI(silness and loe plaque inndex)2-GMSI (gingival modification of the stain index)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Use of chlorhexidine mouthwash in the morning - Mouthwash with hydrogen peroxide - Chlorhexidine in the nourish
Category
Treatment - Drugs
2
Description
Intervention group 2: Using chlorhexidine mouthwash and then immediately hydrogen peroxide in the morning-chlorhexidine and then immediately hydrogen peroxide at night
Category
Treatment - Drugs
3
Description
Intervention group 3: Use hydrogen peroxide mouthwash and then immediately chlorhexidine in the morning - hydrogen peroxide solution and then immediately chlorhexidine at night
Category
Treatment - Drugs
4
Description
Control group 1: Use of chlorhexidine mouthwash in the morning - Chlorhexidine mouthwash at night
Category
Treatment - Drugs
5
Description
Control group2: Use of hydrogen peroxide mouthwash in the morning - Hydrogen Peroxide Mouthwash at Night
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Street address
Hezar Jarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5542
Email
j_yaghini@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Street address
Hezar Jarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5542
Email
j_yaghini@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5542
Email
j_yaghini@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5542
Email
j_yaghini@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5542
Email
j_yaghini@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available