This study aims to compare the effects of Chlorhexidine mouthwash and green tea for treatment of patients with chronic generalized moderate periodontitis. The present study is random double-blind one which includes two parallel control groups treated by placebo. The study made on population included patients with periodontitis referred to sari dental school The total volume of samples is 40 individuals and the intervention is aimed to compare green tea mouthwash efficacy with chlorhexidine and placebo mouthwashes in 3 weeks of intervention. the primary outcomes of this intervention consists of reduction in plaque, gingival and bleeding indicies,.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061434314N2
Registration date:2017-10-25, 1396/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Ashena Sadrzadeh
Name of organization / entity
Mazandaran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4225 1888
Email address
m.babaei@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Oral Chlorhexidine With Green Tea In Treatment Of Patients With Chronic Generalized Periodontitis
Public title
Comparison of Chlorhexidine and Green Tea in Chronic Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria
Inclusion criteria includes all non-smoking patients that are healthy systematically and have more than 20 teeth with middle chronic periodontitisis.
Exclusion Criteria
pregnant mothers ; breastfeeding woman; patients with history of treatment with antibiotics; anti-inflammation drugs ; anti-oxidant drugs ; anti TNF-a treatments during the last 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethical Commite, Mazandaran University Of Medical Sciences
Street address
Shahid Motahari Square, Moalem Street
City
Sari
Postal code
48157-3391
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MAZUMS.REC.95.2442
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis
Primary outcomes
1
Description
Plaque index
Timepoint
Zero,one week,three week
Method of measurement
Check list(periodontal probe)
2
Description
Gingival index
Timepoint
Zero,one week,three week
Method of measurement
Check list(periodontal probe)
3
Description
Gingival Sulcus Bleeding index
Timepoint
Zero,one week,three week
Method of measurement
Check list(wait 15 seconds after pocket probe)
4
Description
Probing Pocket Depth
Timepoint
zero,one week,three week
Method of measurement
check list(periodontal probe)
5
Description
Clinical Attachment Loss
Timepoint
zero,one week,three week
Method of measurement
check list(periodontal probe)
Secondary outcomes
empty
Intervention groups
1
Description
Group case for three weeks will be used Green tea mouthwash.
Category
Placebo
2
Description
The use of chlorhexidine %0.2 in the group for three weeks
Category
Placebo
3
Description
The use of Serum 0.09 in the control group for three weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Hadis Ehsani
Street address
Babol Street, Qaemshahr
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Doctor Ahmad ali Enayati
Street address
Moalem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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.Hadis ehsani
Position
Periodontist
Other areas of specialty/work
Street address
Babol Street, Qaemshahr
City
Qaemshahr
Postal code
Phone
+98 911 854 7442
Fax
Email
hehsani@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Hadis Ehsani
Position
Periodontist
Other areas of specialty/work
Street address
Babol Street, Qaemshahr
City
Qaemshahr
Postal code
Phone
+98 911 854 7442
Fax
Email
hehsani@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Hadis Ehsani
Position
Periodontist
Other areas of specialty/work
Street address
Babol Street, Qaemshahr
City
Qaemshahr
Postal code
Phone
Fax
Email
hehsani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)