Determining and comparing the mean of periodontal indices after using hydrogen peroxide mouthwash in patients with gingivitis
Design
The samples will include 64 patients referred to the pre-ward of the dental school. After obtaining written consent, patients' teeth are first scaled and polished with ultrasonic devices. Health education is given to patients. At this time, patients are randomly divided into 4 groups, patients do not know which groups they are in and the same coverage is considered for mouthwashes. To blind in this study, use a coding system The information phase is phase 3.
Settings and conduct
This study is performed in Isfahan Dental School. Samples will be selected from patients referring to the Periodontics Department of the School. Patients are examined and indicators are recorded in a completely sterile unit at each follow-up. For blinding, mouthwashes are placed in the same cover for patients and the examiner
Participants/Inclusion and exclusion criteria
15 functional teeth at least
Gingival index equal to or greater than 2
Don’t use alcohol and cigarettes
non-existence of systemic diseases that effect gingiva condition
Don’t use drugs that effect periodontal condition
Non-existence of periodontal surgery or condition that effect periodontal diseases
Intervention groups
Control group: This group is considered as a positive control group
It is considered and people in this group will not use mouthwash.
Intervention group 1: in this group are asked to use 0.2% chlorhexidine mouthwash twice a day at a rate of 5 ml for 2 weeks.
Intervention group 2: In this group, people are asked to use 5 ml of hydrogen peroxide mouthwash twice a day for 2 weeks.
Intervention group 3: In this group, people are asked to use placebo mouthwash twice a day in the amount of 5 ml for 2 weeks.
Main outcome variables
Dental plaque/Probe depth /Gingival index /Gingival bleeding index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101006004877N29
Registration date:2021-10-07, 1400/07/15
Registration timing:registered_while_recruiting
Last update:2021-10-07, 1400/07/15
Update count:0
Registration date
2021-10-07, 1400/07/15
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
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hydrogen peroxide and zinc mouth-wash on periodontal indices in patients with chronic gingivitis in randomized clinical trial.
Public title
Effect of hydrogen peroxide and zinc mouth-wash in reducing gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
15 functional teeth at least
Gingivitis in gingival. ( gingival index at least 2 or more )
Don’t use alcohol and cigarettes
non-existence of systemic diseases that effect gingiva condition l
Don’t use drugs that effect periodontal condition
Non-existence of periodontal surgery or condition that effect periodontal diseases
Exclusion criteria:
People with dental anomalies
People over the age of 65
People with a history of orthodontic treatment
People with a history of bleaching treatment.
Age
From 14 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is based on simple decomposition method which is done by lottery method. In this way, 44 envelopes are sealed, in which the four codes related to each of the experimental groups are prepared, and each participant randomly selects one of these envelopes and The base of the code inside the envelope is in one of the test groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In three groups that take mouthwash , mouthwash in the same battles but for reducing ignores , corks of battle manufacturing in three colors. The colors have a code that just researcher have known the codes refer to what kind of mouthwash.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Ethics Committee
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.262
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Decrease in probing death
Timepoint
In the beginning of research- 2 weeks- 6 weeks- 3 months
Method of measurement
By periodontal probe in the mid buccal tooth gingival
2
Description
Plaque index
Timepoint
In the beginning of research- 2 weeks- 6 weeks- 3 months
Method of measurement
For indicating plaque index , using silness&leo plaque index . In this index , 0 demonstrative no microbial plaque , 1 demonstrative a thin layer of plaque in around of free marginal gingival, 2 demonstrative the medium amount of plaque in gingival sulcus and 3 demonstrative large amount of plaque in sulcus or periodontal pocket till free gingival margin.
3
Description
probing bleeding index
Timepoint
In the beginning of research- 2 weeks- 6 weeks- 3 months
Method of measurement
In this criterion, zero indicates the absence of bleeding, one indicates the presence of a specific bleeding point, two indicates the presence of isolated bleeding points in several cases or the presence of a single line of bleeding, three indicates that after probing the triangle between A tooth is immediately filled with blood, and a score of 4 in this index indicates heavy bleeding after probing, which immediately flows into the marginal sulcus.
4
Description
gingival index
Timepoint
In the beginning of research- 2 weeks- 6 weeks- 3 months
Method of measurement
To determine the gingivitis index (GI) of patients, the 4-part Leo & Silness criterion is used, in which zero indicates normal gingiva, one indicates mild inflammation (slight changes in color and mild edema with bleeding during probing), two indicates moderate inflammation. Along with edema redness and bleeding during probing and three also indicate severe inflammation with severe edema redness and ulceration and tendency to bleed simultaneously.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group is considered as a positive control group and people in this group will not use mouthwash.
Category
Treatment - Drugs
2
Description
Intervention group: People in this group are asked to use 0.2% chlorhexidine mouthwash twice a day at a rate of 5 ml for 2 weeks.
Category
Treatment - Drugs
3
Description
Second Intervention group: In this group, people are asked to use 5 ml of hydrogen peroxide mouthwash twice a day for 2 weeks.
Category
Treatment - Drugs
4
Description
third Intervention group: In this group, people are asked to use placebo mouthwash twice a day in the amount of 5 ml for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Alireza Parsapour
Street address
Shohadye Sofhe street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alirezaparsapour10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Nakisa Torabi Nia
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5512
Email
Torabinia@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
Vice chancellor for research, Faculty of Dentistry, Isfahan 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
Jaber Yaghini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Dental School
City
Isfahan
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
Jaber Yaghini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Dental School
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
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
Jaber Yaghini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Dental School
City
Isfahan
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