Comparison of the effect of hypochlorite sodium 0.25% and chlorhexidine 0.2% mouthwash on periodontal indices in treatment of patients with chronic gingivitis : A control clinical trial study
Evaluation and comparison of the effect of 0.25% sodium hypochlorite and 0.2% chlorhexidine on periodontal indices in patients with chronic gingivitis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 20 patients, randomized with block method and randomization.com website
Settings and conduct
Patients with generalized marginal and papillary gingivitis who referred to the Priodontology Department of Mashhad Dental School are selected for the study. Patients are randomly divided into two groups . The first group of patients use 0.2% chlorhexidine mouthwash and the second group of patients use 0.25% hypochlorite mouthwash as an adjunct treatment after brushing twice a day for two weeks. Before using mouthwash and after this period, the condition of the gums is evaluated and compared between the two groups with the help of periodontal indices (PI), (MGI), (BOP) .This study is double blind and data analysor and the outcome assessor are blinde.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Generalized marginal and papillary gingivitis.
Exclusion criteria: Patients with periodontitis; Presence of systemic diseases; Patients who have received antibiotics in the last 6 months; Patients with Necrotizing periodontitis; Use of medications affecting gingival enlargement; Patients with a positive history of HIV, AIDS; smoking >10 cigarettes a day
Intervention groups
Intervention group: Patients in this group use sodium hypochlorite mouthwash with NACLO chemical composition and concentration of 0.25% twice a day for two weeks after brushing.
Control group: Patients in this group use chlorhexidine mouthwash with C22H30CL2N10 chemical composition and a concentration of 0.2% twice a day for two weeks after brushing.
Main outcome variables
Bleeding On Probing Index (BOP);
Modified Gingival Index (MGI);
Plaque Index (PI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200916048739N1
Registration date:2020-10-08, 1399/07/17
Registration timing:registered_while_recruiting
Last update:2020-10-08, 1399/07/17
Update count:0
Registration date
2020-10-08, 1399/07/17
Registrant information
Name
Reyhane Mousavi Neyshabouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 9483
Email address
mousavinr931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hypochlorite sodium 0.25% and chlorhexidine 0.2% mouthwash on periodontal indices in treatment of patients with chronic gingivitis : A control clinical trial study
Public title
The effect of 0.25% sodium hypochlorite mouthwash on gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Generalized marginal and papillary gingivitis
Exclusion criteria:
Patients with periodontitis
Diabetic patients , Severe systemic cardiac patients
Patients who have received antibiotics in the last 6 months
Patients with necrotizing periodontitis
Systemic diseases that cause generalized gingivitis
Patients with a positive history of HIV, AIDS
Patients with tobacco usage in smoked or smokeless form
Immunosuppressive drug therapy or use of medications affecting gingival enlargement
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is block.
In this method, we first specify the valume of each block. In this study, we use blocks with two items. Then we write a list of blocks and assign a number to them (AA1,BB2,AB3,BA4). Finally, random blocks will be selected by using the randomization.com website.
Unit of randomization is individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome Assessor: Mouthwashes are delivered to samples without name and in similar packages. A code is assigned to each sample, so the assessor makes assessments and measurements without knowing the intervention and control groups.
Data Analyzer: Information and data is sent to the assessor without the knowledge of the intervention and control group and with specific codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.060
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
Bleeding On Probing Index (BOP)
Timepoint
At the beginning of the study and 14 days after starting mouthwash
Method of measurement
Using periodontal probe
2
Description
Modified Gingival Index (MGI)
Timepoint
At the beginning of the study and 14 days after starting mouthwash
Method of measurement
Visual observation
3
Description
Plaque Index (PI)
Timepoint
At the beginning of the study and 14 days after starting mouthwash
Method of measurement
Using periodontal probe, Loe and Silness method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group use sodium hypochlorite mouthwash with NACLO chemical composition and concentration of 0.25% (15 mililitr), twice a day for two weeks after brushing.After using the mouthwash they should refrain from eating and drinking for about one hour.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group use chlorhexidine mouthwash with C22H30Cl2N10 chemical composition and a concentration of 0.2%(made by Iran Najo Company) 15 mililitr, twice a day for two weeks after brushing.After using the mouthwash they should refrain from eating and drinking for about one hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of periodontology, Mashhad Faculty of Dentistry
Full name of responsible person
Reyhane Mousavi Neyshabouri
Street address
Periodontology Department, Faculty of Dentistry, Vakilabad Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
MousaviNR931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Zare Mahmoudabadi
Street address
Faculty of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
MousaviNR931@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
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
Mashhad University of Medical Sciences
Full name of responsible person
Reyhane Mousavi Neyshabouri
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 2, No.54, 19 Samanieh Alley., 28 Saremi St., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657335
Phone
+98 51 3881 9483
Fax
Email
MousaviNR931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Nasrabadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Faculty of Dentistry, Vakilabad Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
nasrabadi.nahid@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reyhane Mousavi Neyshabouri
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 2, No.54, 19 Samanieh Alley., 28 Saremi St., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657335
Phone
+98 51 3881 9483
Fax
Email
MousaviNR931@mums.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