Comparing the efficacy of Matricaria chamomilla, Achillea millefolium, and chlorhexidine gluconate mouthwashes on dental plaque and oral mucosal lesions of patients using ventilator in the intensive care unit

To compare the efficacy of Matricaria chamomilla, Achillea millefolium, and chlorhexidine gluconate mouthwashes on dental plaque and oral mucosal lesions of patients using ventilator

A three-arm, parallel-group, triple-blinded randomized clinical trial with a control group

Seventy-five eligible patients admitted to the traumatic intensive care unit of Imam Reza Hospital of Birjand in 2019 will be selected by convenience sampling method and allocated to one control and two intervention groups via permuted block randomization. All patients will be examined for oral mucosal lesions and dental plaque before intervention and on the 2nd and 5th days after intervention. The study is triple-blinded where the patients, care-providers, and data analysts are not aware of the intervention. Patients will be in spine position, and if applicable, the head will be in a 30-degree gradient and the face in a lateral direction. The mouth, gums, tongue, pharynx, and teeth are brushed with a soft brush before intervention. Mouthwashes will be applied on a daily basis, every 8 hours, for 5 days.

Major inclusion criteria: Informed consent provided by the patient or guardian; age between 15 and 65 years; and having an oral tube. Major exclusion criteria: Diabetes and traumatic oral injuries.

There are three 25-member groups. In the control group, 0.2 percent chlorhexidine gluconate mouthwash will be used. In the first intervention group, Matricaria chymomilla extract at a concentration of 10 percent, and in the second intervention group, Achillea millefolium extract at a concentration of 5% will be used.

Oral lesions, dental plaque

Samples will be recruited via convenience sampling method and allocated to study groups via permuted block randomization.

In this study, patients and their companions will be aware of the overall study design but will not be aware of the type of intervention the patient is to receive. Mouthwash solutions will be delivered to the nurses participating in the study in similar containers labeled A, B, or C, and the nurses will not be aware of the solution in the containers. Moreover, the statistical analyzer will not be informed of the interventions.

Deidentified Individual Participant Data Set

after the paper extracted from the research project is published and for six months

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