The aim of this study is evaluation of the effect of mulberry fruit juice for treatment of gingivitis.This study is a randomized double blind clinical trial on 60 patients with acute gingivitis. The selected people are non-smokers and without any systemic disease. The patients divided into 3 groups; Group 1: mulberry juice mouthwash, Group 2: chlorhexidine mouthwash and Group3: normal saline mouthwash. All the patients are instructed to use 10 ml of the mouthwash twice daily (morning and evening) after brushing and flossing. Plaque and gingival indices in the first visit and then at 1 and 2 months after the beginning of treatment are evaluated and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091329802N1
Registration date:2016-10-09, 1395/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-09, 1395/07/18
Registrant information
Name
Somayeh Shahani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3761
Email address
s.shahani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Deputy, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-06-29, 1395/04/09
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of mouthwash containing mulberry (Morus nigra L.) fruit juice for treatment of gingivitis
Public title
Effect of mouthwash containing mulberry for treatment of gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with gingivitis; probing depth 4 mm or less; having at least 24 teeth excluding third molar; Absence of any active carious lesion; bleeding on probing. Exclusion criteria: smokers; using any antibiotics during the last 3 months; presence of any systemic diseases; pregnancy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology, Moallem Square
City
Sari
Postal code
Approval date
2016-06-28, 1395/04/08
Ethics committee reference number
IR.MAZUMS.REC.95.2078
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.0
ICD-10 code description
Acute gingivitis
Primary outcomes
1
Description
Gingival Index
Timepoint
In the first visit and then at 1 and 2 months after the beginning of treatment
Method of measurement
Observation and evaluation
Secondary outcomes
1
Description
Plaque Index
Timepoint
In the first visit and then at 1 and 2 months after the beginning of treatment
Method of measurement
Observation and evaluation
Intervention groups
1
Description
Intervention 1: mulberry 1% mouthwash, twice daily for 2 month, 10 ml every time
Category
Treatment - Drugs
2
Description
Intervention 2 : Chlorhexidine 0.2% mouthwash, twice daily for 2 months, 10 ml every time
Category
Treatment - Drugs
3
Description
intervention 3 : Normal saline mouthwash, twice daily for two months, 10 ml every time
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Maedeh Salehi
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Deputy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad-Ali Enayati
Street address
Research and Technology Deputy, Moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Deputy, 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
Somayeh Shahani
Position
Assistant Professor, Department of Pharmacognosy and Biotechnology
Other areas of specialty/work
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Postal code
Phone
+98 11 3354 3761
Fax
Email
so.shahani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
PhD
Other areas of specialty/work
Street address
Department of Pharmacognosy and Biotechnology, Faculty of Pharmacy, Mazandaran University of Medical Sciences
City
Sari
Postal code
Phone
+98 11 3354 3761
Fax
Email
so.shahani@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
Somayeh Shahani
Position
PhD of Pharmacognosy
Other areas of specialty/work
Street address
City
Sari
Postal code
Phone
Fax
Email
so.shahani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)