The Comparison of the effects of Botanical mouthwashes of Miswak/Aloe Vera and Cholorhexidine on dental
plaque and gingivitis Index of patients having endotracheal tube hospitalized in the Intensive Care Unit.
This is a double blind clinical trial that will be performed to compare the effects of two mouthwashes (Miswak/Aloe Vera and Chlorhexidine) on dental plaque and gingival index in Yazd educational hospitals. 76 patients having endotracheal tube will be chosen according to inclusion and exclusion criteria and will be divided in two groups randomly (Miswak/Aloe Vera and Chlorhexidine). Oral care and mouth washing will be performed in intervention group by the use of 15 ml Miswak/Aloe Vera mouthwash, every 12 hours and for 4 days and in control group by the use of 15 ml Chlorhexidine in the same way. Oral care in both groups will be done similarly. For collecting data (at first and 4 days later), dental plaque index (O'Leary) and gingival index (Loe & Sillness) will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062418212N1
Registration date:2014-10-05, 1393/07/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-05, 1393/07/13
Registrant information
Name
Sahra Rezaei
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
s.rezaee@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-11-28, 1393/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effects of Botanical mouthwashes of Miswak/Aloe Vera and Cholorhexidine on dental
plaque and gingivitis Index of patients having endotracheal tube hospitalized in the Intensive Care Unit.
Public title
The effects of botanical mouthwashes of Miswak/Aloe Vera and Cholorhexidine on healing of dental plaque and gingivitis of Patients having endotracheal tube
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: 18-65 years old; having endotracheal tube through the mouth; admitted to ICU less than 24 hours; no history of allergy to herbal compounds and chlorhexidine; having natural teeth; not have an injury in the mouth and around it;
Exclusion criteria: to discharge from the ICU or die before completing the study; inclination to continue the study; any damage caused by endotracheal tube, air way or any other factors.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran
City
Arak
Postal code
3848176941
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
92-159-5
Health conditions studied
1
Description of health condition studied
Dental plaque
ICD-10 code
K03.6
ICD-10 code description
Deposits [accretions] on teeth
2
Description of health condition studied
Gingival index
ICD-10 code
K05.0
ICD-10 code description
Acute gingivitis
3
Description of health condition studied
Dental plaque
ICD-10 code
K02.1
ICD-10 code description
Caries of dentine
4
Description of health condition studied
Gingival index
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
5
Description of health condition studied
Gingival index
ICD-10 code
K05.4
ICD-10 code description
Periodontosis
Primary outcomes
1
Description
Dental Plaque Index
Timepoint
Immediately before intervention and four days later
Method of measurement
O'Leary Index
2
Description
Gingival Index
Timepoint
Immediately before intervention and four days later
Method of measurement
Loe & Sillness
Secondary outcomes
1
Description
Temperature
Timepoint
Immediately before intervention and four days later
Method of measurement
Thermometer
2
Description
Blood Pressure
Timepoint
Immediately before intervention and four days later
Method of measurement
Millimeters of Mercury, Using Manometer and Blood Pressure Cuff
3
Description
Pulse Rate
Timepoint
Immediately before intervention and four days later
Method of measurement
Pulse Counting
4
Description
Respiratory Rate
Timepoint
Immediately before intervention and four days later
Method of measurement
Respiratory Rate Counting
Intervention groups
1
Description
Intervention group: Using 15 ml of Miswak/Aloe Vera mouthwash, every 12 hours, for 4 days.
Category
Treatment - Drugs
2
Description
Control group: Using 15 ml of Cholorhexidin mouthwash every 12 hours, for 4 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadooghi Hospital of Yazd
Full name of responsible person
Dr. Mohammad Hossien Jarahzadeh, Anesthesiologist, and Intensive Care Fellowship Specialist