In this study the effect of cinnamaldehyde mouthwash 1% on patients with gingivitis was examined. 105 patients with gingivitis who had been referred to the department of oral medicine in Sari Faculty of Dentistry in summer of 1396 were divided into three groups.One group received treatment with licorice mouthwash , the other group received chlorhexidine mouthwash and the last group received placebo. In each group the mouthwash should be used twice a day for about 5 weeks. After three weeks first examination is run to check the GI and PI. Two weeks after the second examination, in the third checking, the final PI and GI are written down. Finally the GI and PI are compared in the three groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082233722N3
Registration date:2017-08-31, 1396/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-31, 1396/06/09
Registrant information
Name
Tahereh Molania
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3861
Email address
tmolania@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Anti-inflammatory Efficacy of Cinnamaldehyde Mouthwash Comparing with Chlorhexidine Gluconate Mouthwash in Patients with Gingivitis
Public title
Evaluation of Anti-inflammatory Efficacy of Cinnamaldehyde Mouthwash Comparing with Chlorhexidine Gluconate Mouthwash in Patients with Gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being a non-smoker; absence of systemic diseases and pregnancy; having at least 24 teeth excluding third molar; absence of active caries lesions; no use of antibiotics within the previous three months; suffering gingivitis with a probing depth of less than 4mm; positive BOP(Bleeding on probing) and finally ensuring patient cooperation.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The number of sampling is chosen by convenient sampling. After that, by random sampling, one group of samples are located in the first intervention group, another group of samples in the second intervention group, and some in the control group. Each individual is assigned a number and then randomly chosen so the objectivity of the research is reached. Blinding for the study subjects (patients) and those who have run the study (researchers) have been carried out.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran university of medical science, The martyr Motahhari square, Street teacher
City
Sari
Postal code
Approval date
2017-07-03, 1396/04/12
Ethics committee reference number
IR.MAZUMS.REC.96.2989
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.0
ICD-10 code description
Necrotizing ulcerative stomatitis
Primary outcomes
1
Description
Gingival index
Timepoint
Before intervention, three weeks after intervention, five weeks after the beginning of intervention
Method of measurement
Periodontal probe
2
Description
Plaque index
Timepoint
Before intervention, three weeks after intervention, five weeks after the beginning of intervention
Method of measurement
Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
The control group use the mouthwash without medicine (placebo) twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .
Category
Treatment - Drugs
2
Description
The first intervention group use the cinnamaldehyde mouthwash 1% twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .
Category
Treatment - Drugs
3
Description
The second intervention group use the chlorhexidine mouthwash 0.2% twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Tahereh Molania
Street address
Dental clinic, Khazar Blvd, Khazar square Sari Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, The martyr Motahhari square, Street teacher
City
Sari
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, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Maedeh Salehi
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
salehimaede1165@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Tahereh Molania
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar squar
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
T_molania117@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Tahereh Molania
Position
Expert mouth disease diagnosis / Associate Professor, Faculty of Dentistry University of Medical Sci
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3354 3861
Fax
Email
T_molania117@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)