]>
IRCT20240304061169N1 IRCT 2024-07-22 Khomein University of Medical Sciences Examining the effect of cinnamol and mint mouthwash on oral mucositis Examining the effect of cinnamol and mint mouthwash on oral mucositis in chemotherapy patients: a clinical trial investigation. 2024-07-22 anticipated 126 Complete https://irct.ir/trial/76795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants will be randomized into three groups for treatment: a control group receiving routine mouthwash, a first intervention group receiving mint mouthwash, and a second intervention group receiving cinnamol mouthwash. The randomization will be conducted using a 6-block method. Six cards are selected. The letter A is written on two cards, the letter B is written on the other two cards, and the letter C is written on the remaining two cards. To conceal the cards, they are placed inside the envelope and turned over several times to obscure their order. When each participant enters, a card is selected for them, and the selected card is discarded. This process is repeated for the next five patients until six people are identified. Then, in the same manner, randomization will be conducted for other groups of 6 people to achieve the desired sample size. Write down the person associated with each block so that the final analysis of the information can be conducted, Blinding description: In this research, which is double-blind, the research samples and the researcher conducting the intervention in this study will be blinded. It has been tried to observe the similarity of the intervention in the groups as much as possible. 3 Oral mucositis. Intervention 1: In the mint group (provided by Barij Essan pharmaceutical company), participants are instructed to utilize mint essence mouthwash, which can be obtained from pharmacies, for a duration of 14 days. The mouthwash should be used three times a day following teeth brushing sessions scheduled in the morning, noon, and night. The recommended method involves diluting 10 drops of peppermint essential oil in 30 cc of water, gargling the solution for one minute, and refraining from consuming any food for an hour thereafter. It is important to note that participants should continue with their regular treatment regimen as prescribed by their healthcare provider, with the exception of using any other topical mouthwash. Group B participants are advised to follow the same protocol, receiving daily mouthwash until the completion of the 14-day period. Intervention 2: Intervention group: In the Cinnamol mouthwash group(provided by Gol Daro pharmaceutical company), participants are instructed to use the mouthwash three times daily following tooth brushing (in the morning, at noon, and at night) for a duration of 14 days. Specifically, individuals are advised to dilute 20-25 drops of the Cinnamol solution in 30 cc of water, gargle with the mixture for one minute, and refrain from eating for one hour thereafter. During this period, participants are to continue with their regular treatment regimen as prescribed by their attending physician, with the exception of using any other topical mouthwash. Intervention 3: In the control group, in addition to the routine treatment, a placebo is also gargled three times a day, in the morning, for 1 minute (receive mouthwash daily until the 14th day) (provided by Barij Essan pharmaceutical company),. After using mouthwash, patients do not consume food or liquids for 1 hour (group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mehran Akbari
Azadi street, Khomein
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 1534 mehranakbari1373@yahoo.com Khomein University of Medical Sciences scientific Mehran Akbari
Azadi street, Khomein
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 1534 mehranakbari1373@yahoo.com Khomein University of Medical Sciences Iran (Islamic Republic of) Written consent from participants Written consent from participantsFull consciousness Admitted to the oncology department of Khansari Hospital Similar treatment protocol age is age 18 maximum age is maximum years. years Having oral mucositis (minimum score of 1) 18 years 70 years Both Lack of consent to continue participating in the research Allergy to or oral or solution The patient's death The history of using mint and cinnamol mouthwashes Continuous use of painkillers and drugs Suffering from gum and tooth diseases K13 Other diseases of lip and oral mucosa Treatment - Drugs Treatment - Devices Placebo In the mint group (provided by Barij Essan pharmaceutical company), participants are instructed to utilize mint essence mouthwash, which can be obtained from pharmacies, for a duration of 14 days. The mouthwash should be used three times a day following teeth brushing sessions scheduled in the morning, noon, and night. The recommended method involves diluting 10 drops of peppermint essential oil in 30 cc of water, gargling the solution for one minute, and refraining from consuming any food for an hour thereafter. It is important to note that participants should continue with their regular treatment regimen as prescribed by their healthcare provider, with the exception of using any other topical mouthwash. Group B participants are advised to follow the same protocol, receiving daily mouthwash until the completion of the 14-day period. Intervention group: In the Cinnamol mouthwash group(provided by Gol Daro pharmaceutical company), participants are instructed to use the mouthwash three times daily following tooth brushing (in the morning, at noon, and at night) for a duration of 14 days. Specifically, individuals are advised to dilute 20-25 drops of the Cinnamol solution in 30 cc of water, gargle with the mixture for one minute, and refrain from eating for one hour thereafter. During this period, participants are to continue with their regular treatment regimen as prescribed by their attending physician, with the exception of using any other topical mouthwash. In the control group, in addition to the routine treatment, a placebo is also gargled three times a day, in the morning, for 1 minute (receive mouthwash daily until the 14th day) (provided by Barij Essan pharmaceutical company),. After using mouthwash, patients do not consume food or liquids for 1 hour (group Oral mucositis. Timepoint: on the first, seventh and fourteenth days. Method of measurement: Scoring of patients' oral mucositis using the WHO scoring system. Khomein University of Medical Sciences Approved 2024-06-19 Khomein University of Medical Sciences Azadi street, Khomein Khomein Markazi Iran (Islamic Republic of)