Comparing the effectiveness of Echinacea, Listerine, and chlorhexidine mouthwashes on oral microbial flora and oral health status of patients in Intensive Care Unit.

Comparing the effectiveness of Echinacea,Listerine, and chlorhexidine mouthwashes on oral microbial flora and oral health status of unconscious patients in Intensive Care Unit.

A randomized clinical trial using blocking method with sealed envelopes with control group with parallel groups, three blinded with a sample size of 180, (three 60-person randomized groups).

Sampling will perform among hospitalized patients in the intensive care unit of Imam Hossein Hospital and Shohadaye Tajrish Hospital in Tehran. Patients will be divided into 3 groups (2 intervention and control). Individuals in each group received 15 cc of echinacea mouthwash, Listerine or Chlorhexidine. The outcome assessor, the research sample who anesthetized and the data analyst will be unaware of allocating the intervention and control groups.

Inclusion criteria:15-65 years old, consciousness level should be lower than 8. utilizing endotracheal tube and hospitalized less than 12 hours in intensive care unit. Exclusion criteria: Active periodontal disease, traumatic and oral anatomic lesions, using antibiotic two weeks before admission, systemic infections, autoimmune and malignant diseases, radiation therapy precedent. using immunosuppressive drugs, allergy to mouthwashes, patients with tracheostomy and pregnant women

Group 1: 15 cc Echinacea mouthwash Group 2: 15 cc Listerine mouthwash Group 3 (control): 15 cc chlorhexidine mouthwash

To review the growth of microorganisms and their colonial characteristics, samples will grow in blood agar medium and then will grow for 48 hours at 37 ° C in the presence of 5-10% CO2. The laboratory will deliver the results as a printed report with patient code, and the data will use for analysis. Beck Oral Assessment Scale, will use to assess oral health in these patients.

The method of randomization is hexagonal blocking and the randomization tool is the sealed envelope. An statistic expert will accomplish the randomization sequence by using the suitable software. Sampling will be done sequentially. In order to concealment, mouthwashes are poured into same bottles and given a code, which the main researcher will not be aware.

The outcome assessor, participants, and data analyst will not be aware of the assigned groups Participants will be unconscious Mouthwashes are poured into same bottles with different codes; which the outcome assessor will not see them. The data analyzer will also not be present in the research environment

The obtained data after testing on 180 participants in Shohada Tajrish and Imam Hossein hospitals can be shared after unidentifiable individuals.

Data will be accessible, 6 months after printing the results

Researchers working in academies and scientific institutions, could access to data and documentation .

To promote and extend the subject under study from other aspects and to compare the results with other relevant scientific results, it is permissible to use documentation and data to improve the level of health.

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After reviewing the reason of requesting to access documentation and data by the researcher, the data and documentation file will be sent to the researcher (one month after submitting the request).