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Comparison of the effectivness of toothbrush and chlorhexidine solution and calendula officinalis extracts in preventing oral lesions in intubated patients

Protocol summary

Study aim
Comparison of The effectivnes of using the toothbrush and chlorhexidine solution and Calendola solution in the prevention of oral cavity lesions in patients intubated in intensive care units
Design
The clinical trial has three groups of parallel, community-based, and pragmatic. Each group has 19 samples. Blind two-way is to random allocation method.
Settings and conduct
After obtaining the necessary permits, the research is done in the intubated patients of Sabzevar's intensive care units. The double-blind study is blind, the assessor and the consulor are blinded to the bias. Trials are performed at intervals of every 12 hours in three groups. The assessment is recorded at the reception and on the fourth and seventh day by the BOAS tool.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obtain informed consent from the legal representative of the patient, intubated patient and in the range of 18 to 65 years old. Having at least 20 healthy teeth, no illness and severe damage to the oral cavity, no coagulation problems and hepatitis B disease, history of HIV and allergic history, no symptoms of aspiration, lack of cover and parcel, dentures and other orthodontic instruments, score greater than 5 The basis of BOAS, lack of pregnancy and lactation in women. Exit criteria: Dissatisfied with the legal representative of the patient to continue cooperation, withdrawal of the tracheal tube, observation of aspiration apparent
Intervention groups
The intervention group 1 consists of intubated patients in the intensive care unit who received: oral toothbrushing ,and control group 2 chlorhexidine solution with toothbrush, and intervention group 3 brush with calendola.
Main outcome variables
The main outcome is the primary outcome of oral cavity health based on the Boas instrument and the secondary outcome variable is the complications of oral cavity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180512039625N1
Registration date: 2019-01-16, 1397/10/26
Registration timing: retrospective

Last update: 2019-01-16, 1397/10/26
Update count: 0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Hosein Norozibami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 7816
Email address
noroozibami@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectivness of toothbrush and chlorhexidine solution and calendula officinalis extracts in preventing oral lesions in intubated patients
Public title
Comparison of effectivness of toothbrush and chlorhexidine solution and calendula officinalis extracts in preventing oral lesions
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the legal representative The patient is Intubated during the study ( oral endotracheal tube). Having age between 18 to 65 years Have at least 20 teeth No severe shaking and ulcers in the mouth No history of hepatitis B and HIV, according to the doctor and see the test Absence of signs of aspiration According to the doctor and see no problem coagulation tests Have not doing dentures No history of allergic lesions and bleeding and periodontal disease in the mouth Lack of oral lesions and oral & maxillofacial fractures or anatomic abnormalities The absence of crowns and dentures and partial plates and other orthodontic devices Lack of grade 5 and less on the tools BOAS Lack of pregnancy and lactation in women
Exclusion criteria:
Legal representative of patient dissatisfaction continued cooperation Out of the endotracheal tube Find aspiration revealed The incidence of allergic reactions
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is simple type using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to avoid bias, the person who carries out the intervention (special care nurse with 22 years of work experience) and the evaluator are different, the assessor is blind about the type of mouthwash procedure. In this study, a statistic counselor is also required to prevent blind bias. Statisticians and counselors are involved with coding patients in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Each sample monitoring period is a week to study the effect of microbial resistance chlorhexidine solution is possible. Marigold solution is used as a mouthwash solution.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Pardis , Shahrak Tohid., Taleghani Blvd., 051
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834714
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.MEDSAB.REC.1397.004

Health conditions studied

1

Description of health condition studied
Mouthwash and prevention of oral cavity lesions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Oral health
Timepoint
Admission, fourth and seventh day of hospitalization
Method of measurement
Beck Oral Assessment Score

Secondary outcomes

1

Description
diseases of lip
Timepoint
Admission, fourth and seventh day of hospitalization
Method of measurement
Beck Oral Assessment Score

2

Description
diseases of oral mucosa
Timepoint
Beck Oral Assessment Score
Method of measurement
Admission, fourth and seventh day of hospitalization

3

Description
Diseases of tongue
Timepoint
Admission, fourth and seventh day of hospitalization
Method of measurement
Beck Oral Assessment Score

4

Description
periodontal diseases
Timepoint
Admission, fourth and seventh day of hospitalization
Method of measurement
Beck Oral Assessment Score

Intervention groups

1

Description
The first intervention group (toothbrush group): in case of lack of contraindication, the patient's bed head is placed at a 30-degree angle and suction of the oral cavity is performed, if necessary. In addition, the sterilized mouthwash set is opened, and all internal and external surfaces of the teeth, gums, tongue, palate, and the trachea, with the exception of lips, are cleaned with a soft toothbrush for three-four minutes. In the end, the oral cavity is washed with 0.9% normal saline solution.
Category
Prevention

2

Description
The second intervention group (toothbrush-calendula group): in case of lack of contraindication, the patient's bed head is placed at a 30-degree angle and suction of the oral cavity is performed, if necessary. The dressing set is opened, and the oral cavity is washed with normal saline. All internal and external surfaces of the teeth, gums, tongue, palate, and the trachea, with the exception of lips, are cleaned with a soft toothbrush for three-four minutes. In the end, the oral cavity was washed with forceps and cotton impregnated with 0.2%calendula solution (five cc) for two and a half minutes. Afterwards, the oral cavity was washed with 0.9% normal saline and suctioned one more time. The oral cavity health was recorded upon admission and at the end of the fourth and seventh days.
Category
Prevention

3

Description
Control group (toothbrush-chlorhexidine): after performing the steps of the toothbrush group, five cc of 0.2% chlorhexidine solution (Mahsa Company) is poured into the sterile receiver. Afterwards, all parts of the oral cavity are washed with forceps and a cotton ball impregnated with 0.2% chlorhexidine solution for two minutes. Following that, we wait up to 30 seconds so that the antimicrobial properties of chlorhexidine could appear. In the final stage, the oral cavity is washed with 0.9% normal saline and is then suctioned. The oral health is recorded by BOAS upon admission, as well as at the end of the fourth and seventh days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Beheshti Hospital in Sabzevar
Full name of responsible person
Hosein norozi bami
Street address
Beheshti hospital, Razi street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834714
Phone
+98 51 4464 0115
Email
noroozibami@medsab.ac.ir

2

Recruitment center
Name of recruitment center
Vasei hospital in Sabzevar
Full name of responsible person
Hosein norozi bami
Street address
Vaseie hospital, Taleghani Blvd, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834714
Phone
+98 51 4465 1300
Email
noroozibami@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Rad mostafa
Street address
Pardis building, Sabzevar University of Medical Sciences, tohid Blvr.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834714
Phone
+98 51 4401 8000
Email
www@medsab.ac.ir
Web page address
http://fa.irct.ir/user/trial/31602/update/sponsor
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
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
Sabzevar University of Medical Sciences
Full name of responsible person
Hosein norozi bami
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 33 , University 3, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834714
Phone
+98 51 4466 7816
Email
norozbam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mosa Al.reza tadayonfar
Position
Faculty of Medical Sciences, Sabzevar
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Building, Tohid Blvd, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8000
Email
mtadayonfar@medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hosein norozi bami
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tohid Blvd, Vaseie hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834714
Phone
+98 44651300
Email
norozbam@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
Comments
-
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