Protocol summary

Summary
The purpose of this study is to provide herbal mouthwashes and comparison their clinical effects with chlorhexidin mouhwash. this research is a double blind randomized (using random permutation blocks) clinical trial done on 140 qualified volunters referring to gum diseasesc department of urmia university medical sciences.In this study patients and researcheres don't aware from kind of intervention. In this way , after obtaining permission from the ethics committe and registering the research on the IRCT site, the researcher selects her own sample of adults who are eligible to enter in the study accordind with enclusion criteria including plaque index above 1.9 ,gingival index upper 1 and etc,and exclusion criteria including pregnancy ,smoking,methabolic diseases and etc. Prepared herbal mouthrinses(tree type of mouthrinse respectively contain zataria multiflora extract,frankincense extract and both extract) and also chlorhexidine mouthrinse are packaging in quite similar containers. The necessary explantations about the study objectives will be given to the volunters and the description sheet will be available to study. In the next step, the letter of consent and personal profile questionnaire is completed.One package cntaining one toothpaste,toothfloss and toothbrush is available to volunters and they are thought how to use them correctly. In the next step the people are randomly assigned to one of the groups ,and according to assigned code, a special mouthrinse is given to them(A,B,C or D). Clinical examination to control the indexes to be considered in the study(plaque index, bleeding index, gingival index, teeth color index) will be done on the first day, fourteen and twenty one. Each week a phone call is made with the participants in the study and the next visit time and how to use the mouthrinse is remembered them. Degree of satisfaction and possible adverse effects were measured by a questionnaire. The obtained information will be analyzed using the SPSS24 software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072435263N1
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
Zoleikha Khoshbakht
Name of organization / entity
Tabriz university medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 9528
Email address
khoshbakhtz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Governent
Expected recruitment start date
2017-08-30, 1396/06/08
Expected recruitment end date
2017-12-30, 1396/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation of mouthrinse from extract of aerial part of zataria multiflora &frankincense as well as evaluation of their clinical effects on oral and dental healthcare's indexes.
Public title
Preparation of mouthrinse from extract of aerial parts of zataria multiflora &frankincense as well as evaluation of their clinical effects on oral and dental diseases.
Purpose
Prevention
Inclusion/Exclusion criteria
Enclusion criteria: 1-plaq index above 1.9. 2-gingival index above 1. 3- not receiving any antibiotic or anti inflamatory drug in the long of this study and one month ago. 4- being literate. 5-having a call number. 6-the desire to participate in this study. Exclusion criteria: 1-systemic diseases. 2-using drugs that cause inflammation in the gum or excerbate the gum diseases. 3-smoking . 4-use of other mouthrinses from four weeks ago . 5-sensitization to plant materials . 6-methabolic diseases(diabet,hyperthyroidism,etc). 7-pregnancy. 8-Doing any dental practices outside the scope of the study. 9-orthodontic patients.
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
It is randomised using of random permutation blocks.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
East azarbaijan university of medical sciences& health services
Street address
Tabriz,golbad street, tabriz university of medical sciences.
City
Tabriz
Postal code
5165665931
Approval date
2017-05-29, 1396/03/08
Ethics committee reference number
IR.tbzmed.REC.1396.161

Health conditions studied

1

Description of health condition studied
Oral& teeth health indexes.
ICD-10 code
ICD-1
ICD-10 code description
Certain infectious and parasitic diseases

Primary outcomes

1

Description
Bleeding index
Timepoint
Before intervention ,fourteen and twenty one day after intervention
Method of measurement
Salcos test and giving grade between 0-3 for it.

2

Description
Teeth color index
Timepoint
Before intervention and fourteen and twenty one day after intervention.
Method of measurement
Abservation and giving a grade between 0-3 for it.

3

Description
Gingivit index
Timepoint
Before intervention and fourteen and twenty one day after intevention
Method of measurement
Abservation and giving grade between 0-3 for it.

4

Description
Plaque index
Timepoint
Efore intervention and fourteen and twenty one day after intevention
Method of measurement
Chewing plaque search tablet and counting the number of plaques.

Secondary outcomes

1

Description
Possible advers effects
Timepoint
Twenty one day after interaction
Method of measurement
Questionnaire

Intervention groups

1

Description
Using herbal mouthrinse contain zataria multiflora extract for 21day (twice in a day)as one of the intervention groupes.
Category
Treatment - Drugs

2

Description
Using mouthrinse contain chlorhexidine for 21day (twice in a day)as control group
Category
Treatment - Drugs

3

Description
Using herbal mouthrinse contain both of zataria multiflora &frankincense extract for 21 day (twice In day) as one of the intervention group
Category
Treatment - Drugs

4

Description
Using herbal mouthrinse contain frankincense extract for 21day (twice in a day) as one of the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gum diseases department urmia university of medical sciences
Full name of responsible person
Ehsan khashabi
Street address
Urmia,alborz street,gum diseases department urmia university of medical cciences
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chncellor for research of tabriz university of medical sciences.
Full name of responsible person
Laleh khodaie dr
Street address
Tabriz,golbad street, tabriz university of medical sciences,traditional medicine department
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chncellor for research of tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Zoleikha khoshbakht
Position
Phd candidate of traditional pharmacy
Other areas of specialty/work
Street address
Tabriz, abresane, golbad street
City
Tabriz
Postal code
Phone
+98 44 3348 7232
Fax
Email
Khoshbakhtz@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia university of medical scienses
Full name of responsible person
Ehsan khashabi dr
Position
Phd dr
Other areas of specialty/work
Street address
Urmia ,alboorz street
City
Urmia
Postal code
Phone
+98 44 3275 4980
Fax
Email
Khashabi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Zoleikha khoshbakht
Position
Phd candidate of traditional pharmacy
Other areas of specialty/work
Street address
Tabriz,golbad street
City
Tabriz
Postal code
Phone
00
Fax
Email
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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