Protocol summary
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Study aim
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Comparison of the effect of toothbrush stick and Persica mouthwash solution on the severity of stomatitis and its pain in patients undergoing chemotherapy in breast cancer
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Design
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Double-blind randomized clinical trial, phase 2 on 75 patients.
A random number table will be used for randomization
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Settings and conduct
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75 patients with breast cancer select via convenience method and randomly assign into three groups of toothbrush stick, Persica mouthwash and control.
Patients' oral health status assess before, 7 and 14 days after the start of treatment for the severity of stomatitis and pain by a trained coworker who is unaware of patients groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: diagnose breast cancer, The first session of chemotherapy, Age 20-60 years, Having natural teeth, no oral malformations, and oral mucousal health, Consent to participate in the study
Ineligible criteria: Use of analgesics, antibiotics, and other mouthwash solutions, Drug addiction and smoking, History of sensitivity to specific substance, Underlying diseases, receiving treatment simultaneously ( radiotherapy)
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Intervention groups
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Intervention group 1: Using toothbrush stick three times a day (after each meal) on the inner, outer and chewing surfaces of the teeth for 5 minutes with forward and backward movements
Intervention group 2: Using soft toothbrush and toothpaste for children three times a day (after each meal) followed by using Persica mouthwash for 30-60 seconds
Control group: receiving routine care in the ward
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Main outcome variables
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Decrease severity and pain due to stomatitis
General information
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Reason for update
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Change and modification of the statistical community
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171002036505N2
Registration date:
2021-04-26, 1400/02/06
Registration timing:
prospective
Last update:
2021-10-17, 1400/07/25
Update count:
1
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Registration date
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2021-04-26, 1400/02/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-23, 1400/08/01
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Expected recruitment end date
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2022-05-21, 1401/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of Salvadora persica stick (miswak) and Persica mouthwash solution on the severity of stomatitis and its pain in patients undergoing chemotherapy for Breast Cancer.
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Public title
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The effect of Salvadora persica stick (miswak) and Persica mouthwash solution on the severity and pain of stomatitis in patients undergoing chemotherapy.
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
The definitive diagnosis of breast cancer
The first session of chemotherapy
Age range of 20-60 years
Having natural teeth, no oral malformations, and oral mucosal health at the time of study
Consent to participate in the study
Exclusion criteria:
Use of analgesics, antibiotics, and other mouthwash solution
Addiction to drugs and smoking
History of sensitivity to specific substance, allergic rhinitis, and dermatitis
Underlying diseases (diabetes mellitus, hepatitis, liver and kidney disorders, and gastrointestinal diseases)
Concomitant treatments such as radiation therapy
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
75
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients who meet the inclusion criteria will be by random allocation method and using dice (Roll of a dice),will be assigned to three groups: toothbrush stick (25 people), Persica mouthwash (25 people) and control (25 people). Numbers 1 and 2 will be considered for the toothbrush stick group, numbers 3 and 4 will be considered for the Persica mouthwash group and numbers 5 and 6 will be considered for the control group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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1. The person who evaluates the mouth of the patients participating in the study is blind. Thus, the mouth evaluation of patients in terms of incidence and severity of stomatitis will be performed by a study colleague who is unaware of the patient group, and the result is coded in the checklist of each group (patients in the Salvadora persica stick intervention group). Will register with M code and Persica mouthwash solution group with P code and control group with C code.
2. The statistical consultant in charge of data analysis will be unaware of the intervention groups; The data will be entered by the researcher with codes M, P, C in SPSS and will be provided to the statistical consultant for analysis.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-01, 1399/11/13
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Ethics committee reference number
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IR.ZAUMS.REC.1399.535
Health conditions studied
1
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Description of health condition studied
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stomatitis
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ICD-10 code
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K12
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ICD-10 code description
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ICD-10-CM Code K12 - Stomatitis and related lesions
2
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Description of health condition studied
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breast cancer
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ICD-10 code
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C50
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ICD-10 code description
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ICD-10-CM Code C50-Malignant neoplasm of breast
Primary outcomes
1
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Description
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stomatitis
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Timepoint
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7 and 14 days after the intervention
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Method of measurement
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World Health Organization (WHO) scale for oral mucositis
2
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Description
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Pain
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Timepoint
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7 and 14 days after the intervention
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Method of measurement
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Visual Analog Scale for Pain
Intervention groups
1
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Description
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Intervention group 1: After moistening the toothbrush stick with cold boiled water for 15 minutes, patients move the toothbrush stick like a normal toothbrush, on the inner, outer and chewing surfaces of the teeth for 5 minutes three times a day (after each meal) and refrain from eating for up to an hour.
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Category
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Prevention
2
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Description
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Intervention group 2: Patients will brush their teeth three times a day (after each meal) with a soft toothbrush and toothpaste for children, followed by using 15 drops of Persica mouthwash diluted with 15 cc teeth for half to one minute and taking it out and refraining from eating for an hour.
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Category
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Prevention
3
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Description
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Control group: Patients will not receive any intervention and will perform routine care.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zahedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available