Investigating the impact of cinnamol and mint mouthwash on oral mucositis in patients undergoing chemotherapy
Design
A clinical trial was conducted on 126 patients, utilizing a controlled group design with parallel groups, double-blinded, and randomized by using a block randomization method in groups of six.
Settings and conduct
This research comprises a randomized clinical trial to be carried out in three distinct groups at Khoansazi Hospital in Arak. Prior to the initiation of chemotherapy, all study participants will receive standardized instruction on proper oral hygiene practices, such as brushing and flossing, in accordance with the guidelines outlined by the World Health Organization. Assessment of oral mucositis will be conducted using the WHO checklist on the first, seventh, and fourteenth days following the commencement of the intervention.
Both the researcher and the participants involved in the study will be blinded to the group assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Written consent from participants؛ Full consciousness ؛ Minimum age 18 and maximum 70 years؛ Having oral mucositis (minimum score of 1)
Exclusion criteria: 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؛Suffering from gum and tooth diseases
Intervention groups
In the routine mouthwash group, participants gargle three times a day with either a placebo that resembles mint drops or cyanmol as part of their daily treatment regimen. In the mint group, mint essence mouthwash is used. They believe that the standard treatment provided by the attending physician will continue as usual, with the exception of using topical mouthwash. In the Cinnamol group, participants use Cinnamol mouthwash.
Main outcome variables
Measuring the possible improvement of mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240304061169N1
Registration date:2024-07-22, 1403/05/01
Registration timing:registered_while_recruiting
Last update:2024-07-22, 1403/05/01
Update count:0
Registration date
2024-07-22, 1403/05/01
Registrant information
Name
Negin Gholami
Name of organization / entity
Khomein University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3833 8322
Email address
negingholami8031@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of cinnamol and mint mouthwash on oral mucositis in chemotherapy patients: a clinical trial investigation.
Public title
Examining the effect of cinnamol and mint mouthwash on oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Khomein University of Medical Sciences
Street address
Azadi street, Khomein
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2024-06-19, 1403/03/30
Ethics committee reference number
IR.KHOMEIN.REC.1403.011
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K13
ICD-10 code description
Other diseases of lip and oral mucosa
Primary outcomes
1
Description
Oral mucositis
Timepoint
on the first, seventh and fourteenth days
Method of measurement
Scoring of patients' oral mucositis using the WHO scoring system
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Devices
3
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari Hospital
Full name of responsible person
Mehran Akbari
Street address
End of University Street, Arak
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
mehranakbari1373@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Dr Abbas Farahani
Street address
Azadi Street, Khomien
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi street, Khomein
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi street, Khomein
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi street, Khomein
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD