Protocol summary
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Study aim
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Evaluation of the Effect of Protact Mouthwash(Zataria Mutiflora) and Chlorhexidine on Candida Albicans and Gingival Indices in Patients Under Fixed Orthodontic Treatment
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Design
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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 saline mouthwash (placebo) and they use mouthwash for 21 days.
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Settings and conduct
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Eligible patients will first undergo sampling to measure the number of candida albicans 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.
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Participants/Inclusion and exclusion criteria
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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, periodontitis or active dental caries, pregnancy and lactation, and sensitivity to mouthwash
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Intervention groups
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Protact Mouthwash(Zataria Mutiflora)
Chlorhexidine Mouthwash
physiological saline as plasebo
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Main outcome variables
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Gingival index(BI.MGI)
Candida albicans number of fung
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190803044423N1
Registration date:
2019-09-15, 1398/06/24
Registration timing:
prospective
Last update:
2019-09-17, 1398/06/26
Update count:
1
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Registration date
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2019-09-15, 1398/06/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-23, 1398/07/01
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Expected recruitment end date
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2020-03-02, 1398/12/12
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the comparative effect of Protact mouthwash (Zataria Multilflora extract) and chlorhexidine on Candida Albicans and gingival indexes in patients undergoing fixed orthodontic treatment
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Public title
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Evaluation of the effect of Protact mouthwash (Zataria Multilflora extract) on Candida Albicans and gingival indexes in patients undergoing fixed orthodontic treatment
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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 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
Not using the recommended health protocol during the study
Do not use mouthwash as instructed during the study period
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Age
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From 13 years old to 30 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-28, 1398/05/06
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Ethics committee reference number
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IR.ZAUMS.REC.1398.213
Health conditions studied
1
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Description of health condition studied
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Candida albicans number of fungi,gingival index
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Candida albicans number of fungi
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Timepoint
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At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
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Method of measurement
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Swab specimen culture from cervical enamel of second premolars and central incisors of both mandibles adjacent to brackets
2
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Description
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Modified gingival index (MGI)
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Timepoint
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At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
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Method of measurement
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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)
3
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Description
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Gingival bleeding Index (BI)
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Timepoint
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At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention
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Method of measurement
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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.
Intervention groups
1
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Description
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Control group: placebo physiological saline
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Category
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Placebo
2
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Description
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Intervention group: protact mouthwash(zataria mutiflora)
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Chlorhexidine Mouthwash 0.12%
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zahedan University of Medical Sciences
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable