The aim of this study is determining the effect of green tea extract on oral lesions in intubated patients admitted in the ICU . In this study 50 intubated patients who are admitted in ICU ward of Sabzevar vasei Hospital, will be randomly divided into two groups. Technique, timing and frequency of mouthwash application is similar in both groups. In the intervention group,10 ml chlorhexidine solution was used and after 1 hour green tea extract was used. This action is done every 8 hours during 4 days. Control group members wash their mouths with 10ml( 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 Mucos plaque score(MPS) and those features are recorded in the checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042127513N1
Registration date:2016-06-15, 1395/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-15, 1395/03/26
Registrant information
Name
Mehdi Farzami
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
farzami.mehdi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Sabzevar University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of green tea extract on oral lesions in intubated patients admitted in the ICU
Public title
The effect of green tea extract on oral lesions
Purpose
Other
Inclusion/Exclusion criteria
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:
death at the time of the study;Separation from mechanical ventilation at the time of the study; View apparent aspiration; existence of allergic reactions and 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:
50
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. For randomization of the patients,random permutation of blocks was used. In this method ,there were four patients in each block(2 chlorhexidin and 2 green tea). Then blocks were chosen randomly 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 Gnabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, next to the asian road, gonabad, iran
City
Gonabad
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
IR.GMU.REC.1394.26
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
k05
ICD-10 code description
Gingivitis and periodontal diseases
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 Ethics committee of Gonabad University of medical sciences and completing the written consent forms by all participants in the study, Patients are divided randomly into two equal groups: 25 patients in intervention and25 in control group. In the intervention group, chlorhexidine solution was used and after one hour10 % green tea extract was used. This action is done every 8 hours during 4 days.
Category
N/A
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.