The aim of this study is comparing and determining the effects of chamomile mouthwash (intervention) and Chlorhexidine solution (control) for preventing of oral lesions. In this study 70 intubated patients who are admitted in ICU ward of Shahid Hashemi-Nejad Hospital, will be randomly into two groups. Technique, timing and frequency of mouthwash application is similar in both groups. In the intervention group, Control group members wash their mouths with chamomile. 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 Mucoid plaque score(MPS) and those features are recorded in the checklist
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015123125774N1
Registration date:2016-06-12, 1395/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-12, 1395/03/23
Registrant information
Name
Shima Yazdanparast
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4441 9566
Email address
yazdanparastsh1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2016-01-04, 1394/10/14
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
determine and compare the effect of chamomile mouthwash with chlorhexidine and the incidence of oral lesion in ICU patients.
Public title
The effect of chlorhexidine, and chamomile are two types 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 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
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee Sabzevar University of Medical Sciences
Street address
Asad Abadi, st.
City
Sabzevar
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
IR.MEDSAB.REC.1394.116
Health conditions studied
1
Description of health condition studied
Gingivitis,other disorder of lip and oral mucosa
ICD-10 code
K05, K13
ICD-10 code description
Gingivitis and periodontal diseases, Other diseases of lip and oral mucosa
Primary outcomes
1
Description
Oral Health
Timepoint
Three times a day for 4 days
Method of measurement
Mucous plaque score
Secondary outcomes
1
Description
Plaque
Timepoint
Three times a day for 4 days
Method of measurement
Mucous plaque score
Intervention groups
1
Description
Control group: 35 patients with a solution of 0.2% Chlorhexidine mouthwash every 8 hours for 4 days.
Category
Prevention
2
Description
Group Intervention: After receiving the code of ethics of Sabzevar University of Medical Sciences and the satisfaction of patients for the study were 35 patients in the intervention group and mouthwashes every 8 hours for 4 days by a swab soaked in chamomile was dissolved.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi-Nejad Hospital
Full name of responsible person
Shima Yazdanparast
Street address
Abo Rayhan, Blvd.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohamad Mohamadzade
Street address
Asad Abadi, st.
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, 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
Shima Yazdanparast
Position
Clinical Nurse Spacialist student
Other areas of specialty/work
Street address
Asad abadi, st.
City
Sabzevar
Postal code
Phone
+98 51 4441 9566
Fax
Email
yazdanparastsh1@mums.ac.ir
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
Other areas of specialty/work
Street address
Asad Abadi, st.
City
Sabzevar
Postal code
Phone
+98 51 4441 9566
Fax
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
Shima Yazdanparast
Position
Clinical Nurse Spacialist student
Other areas of specialty/work
Street address
Asad abadi, st.
City
Sabzevar
Postal code
Phone
+98 51 4441 9566
Fax
Email
yazdanparastsh1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)