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Comparision of the effects of Flower Punica Granatum and Rhus Coriaria Mouthwashes with Cholorhexidine Mouthwash on periodontal indices in 16-25 year fixed orthodontic female patients

Protocol summary

Summary
This study aimed to compare the effects of Punica granatum (PG) and Rhus coriaria (RC) mouthwashes with those of chlorhexidine (CHX), the gold standard, on periodontal parameters in fixed orthodontic patientsThis cross over double blinded randomized clinical trial study was conducted on 42 female (16 – 25 years), who were undergoing fixed orthodontic treatment and presenting to the Orthodontics Department of Shahid Beheshti University and Behfar Clinic . Then patients were divided randomly into four groups. Lobene, Bay and Ainamo, O’leary indeces have been recorded before treatment, after using first mouthwash, then after serum as a placebo, and finally after second mouthwash. In group 1, at first cholorhexidine mouthwash, then flower Punica Granatum mouthwash was prescribed. In group 2, at first cholorhexidine mouthwash, then Rhus Coriaria mouthwash was prescribed. In group 3, at first Rhus Coriaria mouthwash, then cholorhexidine mouthwash was prescribed. In 4, group at first flower Punica Granatum mouthwash, then cholorhexidine mouthwash was prescribed. Each mouthwash was used for 28 days.Patients used 15mL of 0.2% CHX mouthwash twice daily each time for 30 seconds.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031817061N1
Registration date: 2014-07-29, 1393/05/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-29, 1393/05/07
Registrant information
Name
Elahe Vahid Dastjerdie
Name of organization / entity
Dental University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 4707
Email address
elahevahid@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental University of Shahid Beheshti
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effects of Flower Punica Granatum and Rhus Coriaria Mouthwashes with Cholorhexidine Mouthwash on periodontal indices in 16-25 year fixed orthodontic female patients
Public title
Comparision of the effects of Flower Punica Granatum and Rhus Coriaria Mouthwashes with Cholorhexidine Mouthwash on periodontal indices in 16-25 year fixed orthodontic female patients
Purpose
Other
Inclusion/Exclusion criteria
42 female 16 – 25 years subjects with full fixed orthodontic treatment ;absence of extensive carious lesions ; no dental calculus ; having a minimum score of 1 in Lobene’s MGI ; having a minimum score of 1 in GBI by Bay and Ainamo ; gingival sulcus depth of ≤3mm ; no history of corticosteroid therapy in the past three months ; no antibiotic therapy in the past six months ; no systemic disease ; no history of periodontal disease or periodontal surgery ; no history of using mouthrinses for 10 consecutive days in the past three months ; no history of allergy to mouthrinses ; no pregnancy or nursing ; and no cigarette smoking.
Age
From 77 years old to 69 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences , Daneshju Blvd,Velenjak St
City
Tehran
Postal code
Approval date
2014-02-25, 1392/12/06
Ethics committee reference number
116/5376

Health conditions studied

1

Description of health condition studied
Periodontal Indeces in Fix Orthodontic Patients
ICD-10 code
K05
ICD-10 code description
Gingivitis and Periodontal Diseases

Primary outcomes

1

Description
lobene index
Timepoint
28 days
Method of measurement
colour observe of margin and papilla of gingival

2

Description
Bay and Ainamo index
Timepoint
28 days
Method of measurement
probing in salcus.evalute bleeding or not after 10 sec

3

Description
O'leary index
Timepoint
28 days
Method of measurement
use of disclosing sulution

Secondary outcomes

empty

Intervention groups

1

Description
Chlorhexidin Mouthwash 0.2% : Patients used 15mL , twice daily each time for 30 seconds.
Category
Treatment - Drugs

2

Description
Punica Granatum Mouthwas: Patients used 15mL , twice daily each time for 30 seconds.
Category
Treatment - Drugs

3

Description
Rhus Coriari Mouthwas: Patients used 15mL , twice daily each time for 30 seconds.
Category
Treatment - Drugs

4

Description
Serum Mouthwash Patients used 15mL , twice daily each time for 30 seconds.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental University of Shahid Beheshti
Full name of responsible person
Dr.Elahe Vahid Dastjerdie
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Behfar Clinic
Full name of responsible person
Dr.Elahe Vahid Dastjerdie
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental University of Shahid Beheshti
Full name of responsible person
dr.khojaste
Street address
Dental University of Shahid Beheshti , Daneshju Blvd ,Velenjak St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental University of Shahid Beheshti
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
Dental University of Shahid Beheshti
Full name of responsible person
Zahra Shadkar
Position
General Practicinig
Other areas of specialty/work
Street address
Dental University of Shahid Beheshti , Daneshju Blvd ,Velenjak St
City
Tehran
Postal code
Phone
00892188687488
Fax
Email
z.shadkar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental University of Shahid Beheshti
Full name of responsible person
Elahe Vahid Dastjerdi
Position
Associate
Other areas of specialty/work
Street address
Orthodontic Depatment , Dental University of Shahid Beheshti , Daneshju Blvd , Velenjak St
City
Tehran
Postal code
Phone
+98 21 8868 7488
Fax
Email
elahevahid@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental University of Shahid Beheshti
Full name of responsible person
Zahra Shadkar
Position
General Practicinig
Other areas of specialty/work
Street address
Dental University of Shahid Beheshti , Daneshju Blvd , Velenjak St
City
Tehran
Postal code
Phone
+98 21 8868 7488
Fax
Email
z.shadkar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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