Evaluation of the effect of Protact mouthwash (Zataria Multilflora extract) on streptococcus mutans and lactobacillus and gingival indexes in patients undergoing fixed orthodontic treatment
Evaluation of the effect of Protact mouthwash (Zataria Multilflora extract) on Streptococcus mutans and Lactobacillus and gingival indices in patients undergoing fixed orthodontic treatment
Design
In this double-blind clinical trial, 60 eligible patients were randomly divided into three groups of Protact mouthwash ( Zataria Multilflora extract), chlorhexidine mouthwash and physiological serum mouthwash (placebo) and they use mouthwash for 21 days.
Settings and conduct
Eligible patients will first undergo sampling to measure the number of Streptococcus mutans and Lactobacillus colonies as well as screening for modified gingival index (MGI) and gingival bleeding index (BI). They were then randomly assigned to one of three study groups and used mouthwash for 21 days. At the end, the above assessment are re-conducted. The mouthwashes as well as the physiological saline, as placebo, are provided in similar plastic containers with same size, so that the patient and the researcher will not be aware of the type of mouthwash.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients undergoing fixed orthodontic treatment (including brackets on the anterior and premolars and band on first molar), at least three to five months after orthodontic treatment with proper oral hygiene
major exclusion criteria:
Existence of immune insufficient disease or systemic diseases, the presence of severe rotation and malposition in teeth, periodontists or active dental caries, pregnancy and lactation, and sensitivity to mouthwash
Intervention groups
Three groups: Protact mouthwash ( Zataria Multilflora extract), chlorhexidine mouthwash and physiological saline mouthwash (placebo)
Main outcome variables
Streptococcus mutans and Lactobacilli colony count, Modified gingival index (MGI), and Gingival bleeding Index (BI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190803044423N2
Registration date:2019-09-18, 1398/06/27
Registration timing:prospective
Last update:2019-09-18, 1398/06/27
Update count:0
Registration date
2019-09-18, 1398/06/27
Registrant information
Name
bahareh fatemipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 4002
Email address
fatemipourb@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Protact mouthwash (Zataria Multilflora extract) on streptococcus mutans and lactobacillus and gingival indexes in patients undergoing fixed orthodontic treatment
Public title
Evaluation of the effect of Protact mouthwash (Zataria Multilflora extract) on streptococcus mutans and lactobacillus and gingival indexes in patients undergoing fixed orthodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing fixed orthodontic treatment (including brackets on the anterior and premolars and band on first molar)
At least three to five months after orthodontic treatment
Proper oral hygiene
Exclusion criteria:
Existence of immune insufficient disease or systemic diseases
The presence of severe rotation and malposition in the second premolar teeth
Existence of periodontitis
Existence of active dental caries
Smoking and substance use
Taking any antibiotics and antifungal medication for several days before starting the study and during the study period
Pregnancy and lactation
Sensitivity to mouthwash
Use of mouthwash in the past month
The consumption of drinks containing Zataria Multilflora during the study period
Not using the recommended health protocol during the study
Do not use mouthwash as instructed during the study period
Age
From 13 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple random allocation. In such a way, the required number of cards in each study group labeled A, B, and C is placed in a bag. Upon referral, a eligible case is asked to take one of the cards. Card A will be in the control group (placebo), card B will be in the Protact mouthwash (Zataria Multilflora extract) group and card C will be in the chlorhexidine group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The mouthwashes as well as the physiological serum, as placebo, are provided in similar plastic containers with same size, so that the patient and the researcher will not be aware of the type of mouthwash.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.ZAUMS.REC.1398.214
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Streptococcus mutans colony count
Timepoint
At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
Method of measurement
Swab specimen culture from cervical enamel of second premolars and central incisors of both mandibles adjacent to brackets
2
Description
Lactobacilli colony count
Timepoint
At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
Method of measurement
Swab specimen culture from cervical enamel of second premolars and central incisors of both mandibles adjacent to brackets
3
Description
Modified gingival index (MGI)
Timepoint
At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
Method of measurement
The labial/facial surfaces of the gingiva and the interdental papillae of the desired teeth are examined and rated for inflammation from zero (no inflammation) to 4 (severe inflammation)
4
Description
Gingival bleeding Index (BI)
Timepoint
At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
Method of measurement
The probe is carefully inserted into the pocket of the desired tooth, gently moving sideways to the wall of the pocket, and scored based on its bleeding time. In case of no bleeding within 30 seconds, score is zero, in case of bleeding within 30 seconds, score is 1 and in case of immediate bleeding, score is 2.
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Protact mouthwash ( Zataria Multilflora extract)
Category
Prevention
2
Description
Second Intervention group: Chlorhexidine mouthwash
Category
Prevention
3
Description
Control group: Physiological serum mouthwash
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Fatemipour
Street address
East Azadeghan St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3342 9519
Email
Fatemipourb@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Dr. Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
zaums.research@gmail.com
Web page address
http://research.zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Fatemipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,East Azadegan St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3342 9519
Email
Fatemipourb@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Fatemipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,East Azadegan St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 4002
Fax
Email
fatemipourb@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Fatemipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, East Azadegan St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3342 9519
Email
Fatemipourb@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No need.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available