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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201211189664N5 |
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Date of registration:
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2016-08-18 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of implementing oral hygiene protocol on improving the dental plaque and gingival index in patients
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Scientific title:
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Effect of oral hygiene protocol on dental plaque and gingival index in patients with Endotracheal tube hospitalized in intensive care unit |
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Date of first enrolment:
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2016-05-25 |
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Target sample size:
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70 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/10239 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: coin tossing.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Ali ghaempanah
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Address:
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Faculty of Nursing and Midwifery
4515789589
Zanjan
Iran (Islamic Republic of) |
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Telephone:
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+98 24 3314 8300 |
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Email:
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alighaempanah511@gmail.com |
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Affiliation:
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Zanjan University of Medical Sciences |
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Name:
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Mitra payami Bousari
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Address:
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Faculty of Nursing and Midwifery
4515789589
Zanjan
Iran (Islamic Republic of) |
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Telephone:
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+98 24 3314 8300 |
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Email:
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payami@zums.ac.ir |
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Affiliation:
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Zanjan University of Medical Science |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria: males and females 18 to 65 years old having endotracheal tube through the mouth, admitted to ICU less than 12 hours, having natural teeth, no teeth fracture, The absence of coagulopathy, non-pregnancy,
Exclusion criteria: to discharge from the ICU or die before completing the study, no inclination to continue the study by the patient’s custodian.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
65 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Deposits [accretions] on teeth
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Periodontosis
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Chronic gingivitis
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Caries of dentine
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Acute gingivitis
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Condition 1: Dental plaque. Condition 2: gingival index. Condition 3: Dental plaque. Condition 4: gingival index. Condition 5: gingival index.
Deposits [accretions] on teeth
Acute gingivitis
Caries of dentine
Chronic gingivitis
Periodontosis
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Intervention(s)
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Intervention 1: Intervention group: Using 15 ml of Cholorhexidin mouthwash, Use a toothbrush and toothpaste, lubricating lips and wetting the patient's mouth based on Boas tool Adjusted for 4 days. Intervention 2: Control group: Using 15 ml of Cholorhexidin mouthwash every 12 hours, for 4 days.
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Intervention group: Using 15 ml of Cholorhexidin mouthwash, Use a toothbrush and toothpaste, lubricating lips and wetting the patient's mouth based on Boas tool Adjusted for 4 days
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Control group: Using 15 ml of Cholorhexidin mouthwash every 12 hours, for 4 days
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Prevention
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Primary Outcome(s)
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Status Dental Plaque. Timepoint: Immediately before intervention and four days later. Method of measurement: O'Leary Index.
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Status Gingival. Timepoint: Immediately before intervention and four days later. Method of measurement: Loe & Sillness.
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Secondary Outcome(s)
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Oral health. Timepoint: Immediately before intervention and four days later. Method of measurement: BOAS and MPS check lists.
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Source(s) of Monetary Support
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Vice chancellor for research, Zanjan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Zanjan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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