A clinical trial to compare the effect of Bisept mouthwash with Chlorhexidine 0.2% mouthwash on gingival inflammation and dental staning in gingivitis and mild periodontitis patients
(1) Objectives: To compare the impact of Bisept mouthwash with conventional chlorhexidine 0.2% mouthwash on gingival inflammation, plaque accumulation, and tooth stain.
(2) Design: This study is designed as a controlled randomized Parallel single blind clinical trial.
(3) Setting and conduct: Thirty patients with gingivitis or mild periodontitis with clinical signs of erythema, edema and bleeding gums will participate in this study. Then they will be allocated in one of the two groups of test (Bisept mouthwash) and control (conventional chlorhexidine 0.2%) by simple randomization.
(4) Major inclusion criteria: Systemically healthy individuals who are suffering from gingivitis or mild periodontitis with clinical signs of erythema, edema and bleeding gums; Major exclusion criteria: Smoking; Receiving mouthwash or periodontal treatment during the past three months.
(5) Intervention: Each of the participants in test (Bisept mouthwash) or control (conventional chlorhexidine 0.2%) groups will use 15ml mouthwash two times daily for four weeks. The indices for gingival inflammation, plaque accumulation and dental staining will be measured at baseline, two weeks and four weeks and the values change will be compared between the two groups.
(6) Main outcome measures: Gingival inflammation that will be evaluated using the Gingival Index and Bleeding Index and dental staining that is measured using Lobene stain index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031527056N1
Registration date:2017-06-11, 1396/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Nazila Lashkarizadeh
Name of organization / entity
Kerman university of medical sciences, Dental school
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
n_lashkari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effect of Bisept mouthwash with Chlorhexidine 0.2% mouthwash on gingival inflammation and dental staning in gingivitis and mild periodontitis patients
Public title
An evaluation to compare Bisept mouthwash with chlorhexidine 0.2% mouthwash based on the influence on gingival inflammation and dental staining
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: Age 18_50 years old; The presence of plaque induced gingivitis (Gingival Index ≥ 2) or mild periodontitis (1_2 mm Clinical Attachment Loss) so that redness and edema of gingiva and bleeding on probing to be seen on clinical examination; At least 20 teeth present in the mouth (teeth with improper or extensive restorations, extensive caries and third molars would be excluded); Systemically healthy patients.
Exclusion criteria are: A condition that affects immune system such as diabetes and pregnancy; The habit of smoking, alcohol or tobacco consumption; Antibiotics, anti-inflammatory and immunosuppressive drugs intake or mouthwash consumption during the last three months; The presence of removable or fixed appliances in the mouth; Periodontal treatment during the last three months.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Kerman University of Medical Sciences
Street address
Ethics Committee, Vice Chancellor for Research and Technology of University of Medical Sciences Building, First of Ebne Sina Street, Jahad Boulevard, Sommaye Cross road, Kerman
City
Kerman
Postal code
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
IR.Kmu.REC.1395.99
Health conditions studied
1
Description of health condition studied
Mild Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic Periodontitis
2
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic Gingivitis
Primary outcomes
1
Description
Tooth Staining
Timepoint
Baseline, 2 weeks, 4 weeks
Method of measurement
Lobene stain index
2
Description
Gingival inflammation
Timepoint
Baseline, 2 weeks, 4 weeks
Method of measurement
Modified Gingival Index
3
Description
Gingival inflammation
Timepoint
Baseline, 2 weeks, 4 weeks
Method of measurement
Bleeding Index using periodontal probe
Secondary outcomes
1
Description
Dental plaque accumulation
Timepoint
Baseline, 2 weeks, 4 weeks
Method of measurement
Oleary plaque Index
2
Description
dental plaque accumulation
Timepoint
4 weeks
Method of measurement
Observation _ Turesky plaque index
3
Description
side effects or discomfort
Timepoint
4 weeks
Method of measurement
question
Intervention groups
1
Description
Intervention in control group includes 15ml chlorhexidine 0.2% (standard) mouth wash twice daily for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention in test group includes a15ml Bisept mouth wash twice daily for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Keman dental school, Periodontology department
Full name of responsible person
Dr. Nazila Lashkarizadeh assistant proffessor in Periodontology department
Street address
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Vice Chancellor for Research and Technology of University of Medical Sciences Building, First of Ebne Sina Street, Jahad Boulevard, Sommaye Cross road, Kerman
City
Kerman
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 and Technology, Kerman 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
Kerman dental school
Full name of responsible person
Nazila Lashkarizadeh
Position
Specialist in periodontics _ Assistant professor in periodontics department
Other areas of specialty/work
Street address
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman