The aim of this study is comparing the effects of toothbrush (intervention) and Chlorhexidine solution (control) for preventing of oral lesions. In this study 30 intubated patients who are admitted in ICU ward of Shahid Beheshti Hospital, will be randomly divided into two groups. Technique, timing and frequency of mouthwash application is similar in both groups. In the intervention group, internal and external surfaces of the teeth and gums are rotationally brushed by using a soft kid's toothbrush and half a centimeter toothpaste. This action is done every 8 hours during 4 days. Control group members wash their mouths with 0.2 %( Zero point two percent) chlorhexidine solution. This action is also done every 8 hours for 2 minutes during 4 days for control group. patients with age of 18-65 years old who are admitted in ICU Less than 6 hours will be eligible to the study. Transferring from ICU or death before the completion of intervention; allergy to mouthwash; history or current chronic or immune system diseases are exclusion criteria. During the study the mouth is checked three times a day before mouth intervention for four days, the patient's mouth is checked with Boas and Mucoid plaque score(MPS) and those features are recorded in the checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012216309N1
Registration date:2014-04-18, 1393/01/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-18, 1393/01/29
Registrant information
Name
Mohammad Alinejad Moghadam
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 5648
Email address
mohammadalinegad23@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Sabzevar University of Medical Sciences
Expected recruitment start date
2013-11-15, 1392/08/24
Expected recruitment end date
2014-01-18, 1392/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between chlorhexidine solution and toothbrush in prevention of oral lesions in patients hospitalized in intensive care unit
Public title
Comparison the effect of chlorhexidine solution and toothbrush in the prevention of oral lesions
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: Having oral endotracheal tube, being 18-65 years old ,The absence of wound, infection and oral trauma, Not having diseases like hepatitis B and HIV; Not having any symptoms or antecedent of aspiration, serious problems, and artificial teeth. Exclusion criteria are: death at the time of the study, Separation from mechanical ventilation at the time of the study; View apparent aspiration, existence of allergic reactions; restrictions on procedures and aspiration risk.
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this double blind randomized clinical trial samples in the two groups will be labeled by letters A, B and The researcher who measures the Implications of the study is unaware of the intervention groups. Patients are also blind as they are unconscious at the time of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
9613873136
Approval date
2013-11-12, 1392/08/21
Ethics committee reference number
medsab.Rec.92.3
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
k05
ICD-10 code description
Gingivitis and periodontal diseases
2
Description of health condition studied
Other diseases of lip and oral mucosa
ICD-10 code
K13
ICD-10 code description
Other diseases of lip and oral mucosa
3
Description of health condition studied
Diseases of tongue
ICD-10 code
K14
ICD-10 code description
Diseases of tongue
Primary outcomes
1
Description
oral health
Timepoint
Daily for 4 days
Method of measurement
Beck Oral Assessment Scale and Mucosal Plaque Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing the written consent forms by all participants in the study, Patients are divided randomly into two equal groups: 15 patients in intervention and 15 in control group. In the intervention group, internal and external surfaces of the teeth and gums are rotationally brushed by using a soft kid's toothbrush and half a centimeter toothpaste .This action is done every 8 hours during 4 days.
Category
Prevention
2
Description
Control group: control group members wash their mouth with 0.2 %( zero point two percent) chlorhexidine solution. This action is also done every 8 hours for 2 minutes during 4 days but for control group. Also, the observation of mouth is done by BOAS and MPS every 8 hours before utilizing a mouthwash (before washing mouth by chlorhexidine solution). Then, we record it in a checklist.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti Hospital
Full name of responsible person
Mohammad Alinejad Moghadam
Street address
Sabzevar University of Medical Sciences- SHaheed Beheshti Hospital
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research of Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research of Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Alinejad Moghadam
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
Faculty of nursing and midwifery , next to the police station at SHahroud road, Sabzevar
City
Sabzevar
Postal code
9613873136
Phone
+98 57 1441 9573
Fax
+98 57 1444 5648
Email
mohammadalinegad23@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Estaji
Position
MSc./Member of Faculty
Other areas of specialty/work
Street address
Faculty of nursing and midwifery , next to the police station at SHahroud road, Sabzevar
City
Sabzevar
Postal code
9613873136
Phone
+98 57 1441 9573
Fax
+98 57 1444 5648
Email
z.estaji@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Alinejad Moghadam
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
Faculty of nursing and midwifery , next to the police station at SHahroud road, Sabzevar
City
Sabzevar
Postal code
9613873136
Phone
+98 57 1441 9573
Fax
+98 57 1444 5648
Email
mohammadalinegad23@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)