Protocol summary

Summary
The overall goal: Comparing of intubated patients in intensive care unit mouth rinse ortodentol and cholerhexzidin on oral health Interventions and Methods: convenience sampling and were randomly selected and single blind.The intervention group rinse the mouth with vegetable (ortodentol) and the control group with chlorhexidine mouth rinse with 15 mL each time with a soft toothbrush can be rinsed, and the suction within 30 seconds. Before rinsing the mouth at the interval (8, 48, 72 hours) from different areas of the mouth sample and agar cultured and assessment of oral hygiene by standard scale-back and plaque oral mucous measured and the questionnaire will be recorded Primary outcomes: Oral health,Studied groups, endotracheal tube intubation time, the oral microbial

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012232101N1
Registration date: 2017-04-02, 1396/01/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Haydeh Heidari
Name of organization / entity
Medical University
Country
Iran (Islamic Republic of)
Phone
+98 33346699
Email address
heidari.h@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences (government)
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-10-11, 1395/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Ortodentol and chlorhexidine mouthwashes 10% and /12 percent on oral hygiene intubated patients in intensive care units
Public title
Comparing the effect of Ortodentol and chlorhexidine mouthwashes 10% and /12 percent on oral hygiene intubated patients in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included: the patient has an endotracheal tube through the mouth ;with the age of 15-85 years ; 8 hours of intubation in the intensive care unit, before ; no history of allergy is to plant compounds Savory (carvacrol) ; Lack of any damage characterized by endotracheal intubation or planes in the mouth Lesion is unknown. Exclusion criteria included: transmission or discharge or death of the patient from the intensive care unit before the study was completed ; Creating profit any damage characterized by endotracheal intubation or planes or other physical Hram ; Lack of desire to continue to study the patient's legal guardian ; and immune system dysfunction, radiotherapy and chemotherapy and having any malignant disease.
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrekord, Medical,University Ethics Committee
Street address
Blvd , Kashani,
City
Shahrekord
Postal code
8815713471
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.SKUMS.REc.1395.122

Health conditions studied

1

Description of health condition studied
Chronic Obstruactive Pulmanary Disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

2

Description of health condition studied
Diabeteic Mellitus
ICD-10 code
E10,E14
ICD-10 code description
Diabetes mellitus

3

Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
J80
ICD-10 code description
Adult respiratory distress syndrome

4

Description of health condition studied
Multiple Truma
ICD-10 code
T00,T07
ICD-10 code description
Injuries involving multiple body regions

5

Description of health condition studied
Cerebral Vascular Attacke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

6

Description of health condition studied
Gastrointestinal haemorrhage
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal haemorrhage, unspecified

7

Description of health condition studied
Poisoning
ICD-10 code
T96
ICD-10 code description
Sequelae of poisoning by drugs, medicaments and biological substances

8

Description of health condition studied
laparatomy
ICD-10 code
Y60
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care

9

Description of health condition studied
Intracerebral haemorrhage
ICD-10 code
I69
ICD-10 code description
Sequelae of cerebrovascular disease

Primary outcomes

1

Description
Oral Health
Timepoint
Before and after the intervention
Method of measurement
Beck standard questionnaire and measured plaque and oral mucosal

Secondary outcomes

1

Description
Malnutrition
Timepoint
Scale
Method of measurement
Relative

2

Description
Side Efect
Timepoint
Scale
Method of measurement
Relative

Intervention groups

1

Description
The intervention group (mouthwash ortodentoll) ortodentol mouthwash solution containing 10% carvacrol extracts pharmaceutical company Khorramabad, Lorestan building twice a day (morning and evening) each time mouthwash is 15 mm Lytrba used syringes and Ghshh to brush and suction the patient's mouth in 30 seconds.
Category
Prevention

2

Description
The control group (chlorhexidine)Control (chlorhexidine) solution of chlorhexidine / 12% Manufacturing Co. World Health Tehran twice a day (morning and evening) patients intubated mouth rinse with a solution of 15 ml is washed with brushes and suction is then washed and the amount and Read mouth rinse is similar to the intervention group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani , Hospital ,Shahrekord
Full name of responsible person
Hayede Heidari
Street address
School ,of Nursing og Ljósmóðurfræði, Shahrekord
City
Shahrekord

2

Recruitment center
Name of recruitment center
Vali-e-ASR , Hospital , Borūjen
Full name of responsible person
Hojat Mirzakhani
Street address
Blvd , Nation
City
Borūjen

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice , President , Research and Technology , University of Medical Sciences
Full name of responsible person
Dr Abdul Rahim Kazemi
Street address
Blvd , Kashani
City
Shahrekord
Grant name
معاونت پژوهشی و فناوری دانشگاه علوم پزشکی شهرکرد
Grant code / Reference number
2243
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice , President , Research and Technology , University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord , Medical , University
Full name of responsible person
Mirzakhani Hojat
Position
Special , Senior , Nursing , Student
Other areas of specialty/work
Street address
Vali-e-Asr, Hospital , Borujen
City
Borujen
Postal code
8871633411
Phone
00893834226410
Fax
+98 38 3422 6630
Email
mirzakhani.h2014@yahoo.com
Web page address
valiasr hospital @yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University, of Medical , Sciences
Full name of responsible person
Heidari Hayede
Position
PhD Children
Other areas of specialty/work
Street address
Nursing Faculty
City
Sharekord
Postal code
8815713471
Phone
+98 98383346699
Fax
Email
Heidari.h@gmail.com
Web page address
www.skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Shahrekord
Full name of responsible person
Heidari Hayede
Position
PhD Children
Other areas of specialty/work
Street address
RAHMATIEH
City
Shahrekord
Postal code
8815713471
Phone
+98 383335656
Fax
Email
Heidari.h@gmail.com
Web page address
www.skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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